MedPath

A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion

Phase 3
Completed
Conditions
Central Retinal Vein Occlusion
Hemiretinal Vein Occlusion
Macular Edema
Interventions
Drug: Faricimab
Drug: Aflibercept
Procedure: Sham Procedure
Registration Number
NCT04740931
Lead Sponsor
Hoffmann-La Roche
Brief Summary

This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in patients with macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
729
Inclusion Criteria
  • Foveal center-involved macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO), diagnosed no longer than 4 months prior to the screening visit
  • Best-corrected visual acuity (BCVA) of 73 to 19 letters, inclusive (20/40 to 20/400 approximate Snellen equivalent)
  • Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis
  • For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs during the treatment period and for 3 months after the final dose of study treatment
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Exclusion Criteria
  • Any major illness or major surgical procedure within 1 month before screening
  • Uncontrolled blood pressure
  • Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1
  • Pregnant or breastfeeding, or intending to become pregnant during the study

Ocular Exclusion Criteria for Study Eye:

  • History of previous episodes of macular edema due to RVO or persistent macular edema due to RVO diagnosed more than 4 months before screening
  • Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than macular edema due to RVO in the study eye (e.g., ischemic maculopathy, Irvine-Gass syndrome, foveal atrophy, foveal fibrosis, pigment abnormalities, dense subfoveal hard exudates, or other non-retinal conditions)
  • Macular laser (focal/grid) in the study eye at any time prior to Day 1
  • Panretinal photocoagulation in the study eye within 3 months prior to Day 1 or anticipated within 3 months of study start on Day 1
  • Any prior or current treatment for macular edema; macular neovascularization, including diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD); and vitreomacular-interface abnormalities, including, but not restricted to, IVT treatment with anti-VEGF, steroids, tissue plasminogen activator, ocriplasmin, C3F8, air or periocular injection
  • Any prior intervention with verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or vitreo-retinal surgery including sheathotomy
  • Any prior steroid implant use including dexamethasone intravitreal implant (Ozurdex) and fluocinolone acetonide intravitreal implant (Iluvien)

Ocular Exclusion Criteria for Both Eyes:

  • Prior IVT administration of faricimab in either eye
  • History of idiopathic or autoimmune-associated uveitis in either eye
  • Active periocular, ocular or intraocular inflammation or infection (including suspected) in either eye on Day 1
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)Sham ProcedureIn Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).
Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)Sham ProcedureIn Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).
Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)FaricimabIn Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).
Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)FaricimabIn Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).
Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)AfliberceptIn Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).
Primary Outcome Measures
NameTimeMethod
Part 1: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 24From Baseline through Week 24

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.

Secondary Outcome Measures
NameTimeMethod
Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24Baseline, Weeks 4, 8, 12, 16, 20, and 24

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Part 1: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24Baseline, Weeks 4, 8, 12, 16, 20, and 24

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Part 1: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24Baseline, Weeks 4, 8, 12, 16, 20, and 24

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24Baseline, Weeks 4, 8, 12, 16, 20, and 24

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.

Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Week 24From Baseline through Week 24

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Part 1: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24Baseline, Weeks 4, 8, 12, 16, 20, and 24

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Part 1: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 24Baseline, Weeks 4, 8, 12, 16, 20, and 24

Absence of diabetic macular edema was defined as achieving a central subfield thickness of \<325 microns in the study eye. Central subfield thickness was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Part 1: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24Baseline, Weeks 4, 8, 12, 16, 20, and 24

Intraretinal fluid and subretinal fluid were measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24Baseline, Weeks 4, 8, 12, 16, 20, and 24

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Part 1: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24Baseline, Weeks 4, 8, 12, 16, 20, and 24

Subretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Part 1: Change From Baseline in National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) Composite Score at Week 24Baseline and Week 24

The NEI VFQ-25 captures a patient's perception of vision-related functioning and vision-related quality of life. The core measure includes 25 items that comprise 11 vision-related subscales and 1 item on general health. The composite score ranges from 0 to 100, with higher scores indicating better vision-related functioning. For the ANCOVA analysis, the model uses the non-missing change from baseline in BCVA at Weeks 24 as the response variables adjusted for the treatment group, baseline NEI VFQ-25 Composite Score (continuous), baseline BCVA score (≥55 and ≤54 letters) and region (U.S. and Canada, Asia, and the rest of the world). Observed NEI VFQ-25 assessments were used regardless of the occurrence of intercurrent events. Missing data were not imputed. 95% CI is a rounding of 95.03% CI.

Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24Baseline, Weeks 4, 8, 12, 16, 20, and 24

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Part 1: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24Baseline, Weeks 4, 8, 12, 16, 20, and 24

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Part 1: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24Baseline, Weeks 4, 8, 12, 16, 20, and 24

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Part 1: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24Baseline, Weeks 4, 8, 12, 16, 20, and 24

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (\>38 and ≤38 letters) and region (U.S. and Canada, Asia, and rest of the world). All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Part 1: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24Baseline, Weeks 4, 8, 12, 16, 20, and 24

Intraretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.

Part 1: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24Baseline, Weeks 4, 8, 12, 16, 20, and 24

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Parts 1 and 2: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (\>38 and ≤38 letters) and region (U.S. and Canada, Asia, and rest of the world). All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Part 1: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 24Baseline, Weeks 4, 8, 12, 16, 20, and 24

Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the Bruch's membrane (BM) using optical coherence tomography (OCT), as assessed by the central reading center. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline CST (continuous), and randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.

Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) using optical coherence tomography (OCT), as assessed by the central reading center. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline CST (continuous), and randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.

Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Parts 1 and 2: Change From Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints Through Week 72Baseline, Weeks 24, 48, and 72

The NEI VFQ-25 captures a patient's perception of vision-related functioning and vision-related quality of life. The core measure includes 25 items that comprise 11 vision-related subscales and 1 item on general health. The composite score ranges from 0 to 100, with higher scores indicating better vision-related functioning. For the MMRM analysis, the model adjusted for the treatment group, visit, visit-by-treatment group interaction, baseline NEI VFQ-25 Composite Score continuous), baseline BCVA score (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and the rest of the world). Observed NEI VFQ-25 assessments were used regardless of the occurrence of intercurrent events. Missing data were implicitly imputed. Invalid BCVA values were excluded. 95% CI is a rounding of 95.03% CI.

Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Absence of diabetic macular edema was defined as achieving a central subfield thickness of \<325 microns in the study eye. Central subfield thickness was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Intraretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Subretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading ScalePart 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72

This analysis of adverse events (AEs) only includes ocular AEs that occurred in the study eye. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. Ocular AEs of special interest included the following: Suspected transmission of an infectious agent by the study drug; Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, require surgical or medical intervention to prevent permanent loss of sight, or are associated with severe intraocular inflammation (IOI).

Number of Participants With Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and Post-Baseline During the StudyPredose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72

Anti-drug antibodies (ADAs) against fariciamb were detected in plasma using a validated bridging enzyme-linked immunosorbent assay (ELISA). The number of participants with treatment-emergent ADA-positive samples includes post-baseline evaluable participants with at least one treatment-induced (defined as having an ADA-negative sample or missing sample at baseline and any positive post-baseline sample) or treatment-boosted (defined as having an ADA-positive sample at baseline and any positive post-baseline sample with a titer that is equal to or greater than 4-fold baseline titer) ADA-positive sample during the study treatment period. Treatment-unaffected ADA-positive is a post-baseline sample with a titer that is lower than 4-fold the ADA-positive baseline titer (faricimab arm) or the ADA-positive titer prior to first faricimab injection (aflibercept arm).

Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Intraretinal fluid and subretinal fluid were measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Part 2: Number of Study Drug Injections Received in the Study Eye From Week 24 Through Week 72From Week 24 to Week 72
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.

Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Incidence of Ocular Adverse Events in the Fellow EyePart 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72

This analysis of adverse events (AEs) only includes ocular AEs that occurred in the fellow eye. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. Ocular AEs of special interest included the following: Suspected transmission of an infectious agent by the study drug; Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, require surgical or medical intervention to prevent permanent loss of sight, or are associated with severe intraocular inflammation (IOI).

Incidence of Non-Ocular Adverse EventsPart 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72

This analysis of adverse events (AEs) only includes non-ocular (systemic) AEs. Investigators sought information on adverse events (AEs) at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. The non-ocular AE of special interest was: Cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law.

Plasma Concentration of Faricimab Over TimePredose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72
Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.

Part 2: Percentage of Participants on Different Treatment Intervals at Week 68Week 68

In Part 2 of the study, participants in both the faricimab Q4W and aflibercept Q4W arms in Part 1 received 6 mg faricimab intravitreal injections administered according to a personalized treatment interval (PTI) dosing regimen in intervals between Q4W and Q16W. At faricimab dosing visits, treatment intervals were maintained or adjusted (i.e., increased by 4 weeks or decreased by 4, 8, or 12 weeks), based on central subfield thickness (CST) and BCVA values.

Trial Locations

Locations (194)

Fort Lauderdale Eye Institute

🇺🇸

Plantation, Florida, United States

Assoc Retinal Consultants PC

🇺🇸

Royal Oak, Michigan, United States

Midwest Vision Research Foundation

🇺🇸

Chesterfield, Missouri, United States

Texas Retina Associates

🇺🇸

Dallas, Texas, United States

West Virginia University Eye Institute

🇺🇸

Morgantown, West Virginia, United States

Sydney Retina Clinic and Day Surgery

🇦🇺

Sydney, New South Wales, Australia

Hadassah MC; Ophtalmology

🇮🇱

Jerusalem, Israel

Barnet Dulaney Perkins Eye Center

🇺🇸

Mesa, Arizona, United States

Buenos Aires Mácula

🇦🇷

Ciudad Autonoma Buenos Aires, Argentina

Sierra Eye Associates

🇺🇸

Reno, Nevada, United States

Kurume University Hospital

🇯🇵

Fukuoka, Japan

Kansai Medical University Medical Center

🇯🇵

Osaka, Japan

Dobry Wzrok Sp Z O O

🇵🇱

Gda?sk, Poland

Retina Associates Southwest PC

🇺🇸

Tucson, Arizona, United States

Oftar

🇦🇷

Mendoza, Argentina

Budapest Retina Associates Kft.

🇭🇺

Budapest, Hungary

Tel Aviv Sourasky MC; Ophtalmology

🇮🇱

Tel Aviv, Israel

Bajcsy-Zsilinszky Hospital

🇭🇺

Budapest, Hungary

Szegedi Tudományegyetem ÁOK; Department of Ophtalmology

🇭🇺

Szeged, Hungary

Retina Group of New England

🇺🇸

Waterford, Connecticut, United States

Rambam Medical Center; Opthalmology

🇮🇱

Haifa, Israel

Kaplan Medical Center; Ophtalmology

🇮🇱

Rehovot, Israel

Sugita Eye Hospital

🇯🇵

Aichi, Japan

Nagoya University Hospital

🇯🇵

Aichi, Japan

Toho University Sakura Medical Center

🇯🇵

Chiba, Japan

MT Medic Krosno

🇵🇱

Krosno, Poland

Intersec Research and Technology Complex ?Eye Microsurgery? n.a. S.N. Fyodorov; Cheboksary Branch

🇷🇺

Cheboksary, Marij EL, Russian Federation

Hospital General de Catalunya

🇪🇸

San Cugat Del Valles, Barcelona, Spain

1 Saint-Petersburg St. Med. University named after academician I.P.Pavlov; Chair of ophathalmology

🇷🇺

Sankt-peterburg, Sankt Petersburg, Russian Federation

Retina Vit Surgeons/Central NY

🇺🇸

Liverpool, New York, United States

Retinal Diagnostic Center

🇺🇸

Campbell, California, United States

The Retina Partners

🇺🇸

Encino, California, United States

East Bay Retina Consultants

🇺🇸

Oakland, California, United States

Colorado Retina Associates, PC

🇺🇸

Lakewood, Colorado, United States

Retina Consultants of Southern Colorado PC

🇺🇸

Colorado Springs, Colorado, United States

Florida Eye Associates

🇺🇸

Melbourne, Florida, United States

Advanced Research

🇺🇸

Deerfield Beach, Florida, United States

Rand Eye

🇺🇸

Deerfield Beach, Florida, United States

Georgia Retina PC

🇺🇸

Marietta, Georgia, United States

Retina Consultants of Hawaii

🇺🇸

'Aiea, Hawaii, United States

Retina Vitreous Assoc of FL

🇺🇸

Saint Petersburg, Florida, United States

Southeast Retina Center

🇺🇸

Augusta, Georgia, United States

Northwestern Medical Group/Northwestern University

🇺🇸

Chicago, Illinois, United States

Retina Associated Ltd

🇺🇸

Elmhurst, Illinois, United States

University Retina and Macula Associates, PC

🇺🇸

Oak Forest, Illinois, United States

Prairie Retina Center

🇺🇸

Springfield, Illinois, United States

Johns Hopkins Med; Wilmer Eye Inst

🇺🇸

Baltimore, Maryland, United States

Retina Associates

🇺🇸

Lenexa, Kansas, United States

Retina Group of Washington

🇺🇸

Chevy Chase, Maryland, United States

Cumberland Valley Retina PC

🇺🇸

Hagerstown, Maryland, United States

Retina Assoc of Western NY

🇺🇸

Rochester, New York, United States

Black Hills Eye Institute

🇺🇸

Rapid City, South Dakota, United States

Palmetto Retina Center

🇺🇸

West Columbia, South Carolina, United States

Retina Res Institute of Texas

🇺🇸

Abilene, Texas, United States

Retina Consultants of Texas

🇺🇸

The Woodlands, Texas, United States

Fundacion Zambrano

🇦🇷

Caba, Argentina

Oftalmos

🇦🇷

Capital Federal, Argentina

Centro Oftalmológico Dr. Charles S.A.

🇦🇷

Capital Federal, Argentina

Hospital Italiano; Ophtalmology

🇦🇷

Capital Federal, Argentina

Centro Oftalmólogos Especialistas

🇦🇷

Rosario, Argentina

Strathfield Retina Clinic

🇦🇺

Strathfield, New South Wales, Australia

Organizacion Medica de Investigacion

🇦🇷

San Nicolás, Argentina

Eyeclinic Albury Wodonga

🇦🇺

Albury, New South Wales, Australia

Save Sight Institute

🇦🇺

Sydney, New South Wales, Australia

Centre For Eye Research Australia

🇦🇺

East Melbourne, Victoria, Australia

Retina Specialists Victoria

🇦🇺

Rowville, Victoria, Australia

The Lions Eye Institute

🇦🇺

Nedlands, Western Australia, Australia

LKH-Univ.Klinikum Graz; Universitäts-Augenklinik

🇦🇹

Graz, Austria

Hospital de Olhos de Aparecida - HOA

🇧🇷

Aparecida de Goiania, GO, Brazil

Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

🇦🇹

Wien, Austria

Hospital das Clinicas - UFRGS

🇧🇷

Porto Alegre, RS, Brazil

Botelho Hospital da Visao

🇧🇷

Blumenau, SC, Brazil

West China Hospital, Sichuan University

🇨🇳

Chengdu, China

The 2nd Affiliated Hospital of Harbin Medical University

🇨🇳

Harbin, China

Shanghai Tenth People's Hospital

🇨🇳

Shanghai, China

Tianjin Eye Hospital

🇨🇳

Tianjin City, China

Hosp de Olhos de Sorocaba

🇧🇷

Sorocaba, SP, Brazil

Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia

🇧🇷

Sao Paulo, SP, Brazil

Beijing Hospital of Ministry of Health

🇨🇳

Beijing, China

Zhongshan Ophthalmic Center, Sun Yat-sen University

🇨🇳

Guangzhou City, China

The Second Affiliated Hospital of Zhejiang University School of Medicine

🇨🇳

Hangzhou City, China

Shanghai First People's Hospital

🇨🇳

Shanghai, China

The University of Hong Kong-Shenzhen Hospital; Local Ethic Committee

🇨🇳

Shenzhen City, China

AXON Clinical

🇨🇿

Prague, Czechia

He Eye Specialist Shenyang Hospital

🇨🇳

Shenyang City, China

Renmin Hospital of Wuhan University

🇨🇳

Wuhan, China

Henan Provincial Eye Hosptial

🇨🇳

Zhengzhou, China

Tianjin Medical University Eye Hospital

🇨🇳

Tianjin City, China

Chi De Creteil; Ophtalmologie

🇫🇷

Creteil, France

Eye Hospital, Wenzhou Medical University

🇨🇳

Wenzhou City, China

General Teaching Hospital Prague; Ophthalmology clinic

🇨🇿

Prague, Czechia

Centre Ophtalmologique; Imagerie et laser

🇫🇷

Paris, France

Hopital Lariboisiere; Ophtalmologie

🇫🇷

Paris, France

Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik

🇩🇪

Ludwigshafen, Germany

Universitätsklinikum Freiburg, Klinik für Augenheilkunde

🇩🇪

Freiburg, Germany

Centres Ophtalmologique St Exupéry; Ophtalmologie

🇫🇷

St Cyr Sur Loire, France

Queen Mary Hospital; Department of Ophthalmology

🇭🇰

Hong Kong, Hong Kong

Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

🇭🇺

Debrecen, Hungary

Zala Megyei Kórház; SZEMESZET

🇭🇺

Zalaegerszeg, Hungary

Rabin MC; Ophtalmology

🇮🇱

Petach Tikva, Israel

Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico

🇮🇹

Roma, Lazio, Italy

Irccs Ospedale San Raffaele;U.O. Oculistica

🇮🇹

Milano, Lombardia, Italy

Aichi Medical University Hospital

🇯🇵

Aichi, Japan

Hayashi Eye Hospital

🇯🇵

Fukuoka, Japan

Asahikawa Medical University Hospital

🇯🇵

Hokkaido, Japan

Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)

🇯🇵

Hyogo, Japan

Kozawa eye hospital and diabetes center

🇯🇵

Ibaraki, Japan

Kagawa University Hospital

🇯🇵

Kagawa, Japan

Kagoshima University Hospital

🇯🇵

Kagoshima, Japan

Shinshu University Hospital

🇯🇵

Nagano, Japan

Mie University Hospital

🇯🇵

Mie, Japan

Osaka Metropolitan University Hospital

🇯🇵

Osaka, Japan

Tokyo Women's Medical University Hospital

🇯🇵

Tokyo, Japan

Pusan National University Hospital

🇰🇷

Busan, Korea, Republic of

Yeungnam University Medical Center

🇰🇷

Daegu, Korea, Republic of

Kyung Hee University Hospital

🇰🇷

Seoul, Korea, Republic of

Seoul National University Hospital

🇰🇷

Seoul, Korea, Republic of

Kim's Eye Hospital

🇰🇷

Seoul, Korea, Republic of

Samsung Medical Center

🇰🇷

Seoul, Korea, Republic of

Asan Medical Center

🇰🇷

Seoul, Korea, Republic of

Szpital sw. Lukasza

🇵🇱

Bielsko-Biala, Poland

OFTALMIKA Sp. z o.o

🇵🇱

Bydgoszcz, Poland

Specjalistyczny O?rodek Okulistyczny Oculomedica

🇵🇱

Bydgoszcz, Poland

Optimum Profesorskie Centrum Okulistyki

🇵🇱

Gda?sk, Poland

Szpital Specjalistyczny nr 1; Oddzial Okulistyki

🇵🇱

Bytom, Poland

Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT

🇵🇱

Gliwice, Poland

SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej

🇵🇱

Krakow, Poland

Gabinet Okulistyczny Prof Edward Wylegala

🇵🇱

Katowice, Poland

Centrum Medyczne Dietla 19 Sp. Z O.O.

🇵🇱

Kraków, Poland

O?rodek Chirurgii Oka Prof. Zagórskiego Na??czów

🇵🇱

Na??czów, Poland

Lens Clinic

🇵🇱

Rybnik, Poland

Centrum Medyczne Pulawska SP. z o.o.

🇵🇱

Piaseczno, Poland

Espaco Medico Coimbra

🇵🇹

Coimbra, Portugal

Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia

🇵🇹

Coimbra, Portugal

Caminomed

🇵🇱

Tarnowskie Góry, Poland

Centrum Zdrowia MDM

🇵🇱

Warszawa, Poland

Hospital de Santa Maria; Servico de Oftalmologia

🇵🇹

Lisboa, Portugal

Clinic Optimed

🇷🇺

UFA, Baskortostan, Russian Federation

Medical Military Academy n.a S.M.Kirov

🇷🇺

St.Petersburg, Sankt Petersburg, Russian Federation

Tan Tock Seng Hospital; Ophthalmology Department

🇸🇬

Singapore, Singapore

Singapore Eye Research Institute

🇸🇬

Singapore, Singapore

Complejo Hospitalario de Navarra; Servicio de oftalmologia

🇪🇸

Pamplona, Navarra, Spain

Hospital de Santa Creu I Sant Pau; Servicio de Oftalmologia

🇪🇸

Barcelona, Spain

Centro de Oftalmologia Barraquer; Servicio Oftalmologia

🇪🇸

Barcelona, Spain

Hospital Universitario Puerta de Hierro

🇪🇸

Majadahonda, Madrid, Spain

Hospital Universitario Rio Hortega; Servicio de Oftalmologia

🇪🇸

Valladolid, Spain

Changhua Christian Hospital; Department of Ophthalmology

🇨🇳

Changhua, Taiwan

Hospital Clinic de Barcelona; Consultas Externas Oftalmologia

🇪🇸

Barcelona, Spain

Chang Gung Medical Foundation - Linkou; Ophthalmology

🇨🇳

Taoyuan, Taiwan

Taipei Veterans General Hospital; Ophthalmology

🇨🇳

Taipei, Taiwan

Birmingham Midland Eye Centre

🇬🇧

Birmingham, United Kingdom

University Hospital of Wales

🇬🇧

Cardiff, United Kingdom

Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL

🇬🇧

Belfast, United Kingdom

Opthalmology Research Office

🇬🇧

Bradford, United Kingdom

Bristol Eye Hospital;Retinal Treatment and Research Unit

🇬🇧

Bristol, United Kingdom

Central Middlesex Hospital

🇬🇧

London, United Kingdom

Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre

🇬🇧

Liverpool, United Kingdom

St James University Hospital

🇬🇧

Leeds, United Kingdom

Royal Victoria Infirmary

🇬🇧

Newcastle upon Tyne, United Kingdom

Maidstone and Tunbridge Wells NHS Trust

🇬🇧

Maidstone, United Kingdom

Piedmont Eye Center

🇺🇸

Lynchburg, Virginia, United States

Mid Atlantic Retina - Wills Eye Hospital

🇺🇸

Philadelphia, Pennsylvania, United States

VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota

🇺🇸

Edina, Minnesota, United States

Cincinnati Eye Institute

🇺🇸

Cincinnati, Ohio, United States

California Eye Specialists Medical group Inc.

🇺🇸

Pasadena, California, United States

Northern California Retina Vitreous Associates

🇺🇸

Mountain View, California, United States

Retina Consultants, San Diego

🇺🇸

Poway, California, United States

Retina Consultants of Orange County

🇺🇸

Fullerton, California, United States

Charleston Neuroscience Institute

🇺🇸

Ladson, South Carolina, United States

Charles Retina Institute

🇺🇸

Germantown, Tennessee, United States

Long Is. Vitreoretinal Consult

🇺🇸

Hauppauge, New York, United States

Cascade Medical Research Institute LLC

🇺🇸

Springfield, Oregon, United States

Retina & Vitreous of Texas

🇺🇸

Bellaire, Texas, United States

Grupo Laser Vision

🇦🇷

Rosario, Argentina

Strategic Clinical Research Group, LLC

🇺🇸

Willow Park, Texas, United States

The Second Hospital of Jilin University

🇨🇳

Changchun, China

Internationale Innovative Ophthalmochirurgie GbR; c/o Makula-Netzhaut-Zentrum Breyer Kaymak Klabe

🇩🇪

Düsseldorf-Oberkassel, Germany

Nagoya City University Hospital

🇯🇵

Aichi, Japan

Hyogo Medical University Hospital

🇯🇵

Hyogo, Japan

Fukushima Medical University Hospital

🇯🇵

Miyagi, Japan

Tokyo Medical University Hachioji Medical Center

🇯🇵

Tokyo, Japan

Seoul National University Bundang Hospital

🇰🇷

Seongnam-si, Korea, Republic of

SPEKTRUM Osrodek Okulistyki Klinicznej

🇵🇱

Wroclaw, Poland

FSBI ?Scientific Research Institute of Eye Diseases? of Russian Academy of medical Sciences

🇷🇺

Moscow, Moskovskaja Oblast, Russian Federation

Hospital Universitario de Bellvitge

🇪🇸

Hospitalet de Llobregat, Barcelona, Spain

West Coast Retina Medical Group

🇺🇸

San Francisco, California, United States

Retina Associates of Florida, LLC

🇺🇸

Tampa, Florida, United States

Retina Northwest

🇺🇸

Portland, Oregon, United States

Retinal Research Institute, LLC

🇺🇸

Phoenix, Arizona, United States

Tennessee Retina PC

🇺🇸

Nashville, Tennessee, United States

Austin Retina Associates

🇺🇸

Austin, Texas, United States

Austin Clinical Research LLC

🇺🇸

Austin, Texas, United States

Retina Associates of Utah, PLLC

🇺🇸

Salt Lake City, Utah, United States

Hong Kong Eye Hospital; CUHK Eye Centre

🇭🇰

Mongkok, Hong Kong

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