A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Assess the Efficacy and Safety of Lampalizumab Administered Intravitreally to Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 975
- Locations
- 152
- Primary Endpoint
- Change From Baseline in Geographic Atropy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48
Study Overview
Brief Summary
This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants aged greater than or equal to (>/=) 50 years
- •Well demarcated area(s) of Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD) with no evidence of prior or active choroidal neovascularization (CNV) in both eyes
Exclusion Criteria
- •Ocular Exclusion Criteria (Study Eye):
- •History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
- •Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy
- •Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation)
- •Ocular Exclusion Criteria (Both Eyes):
- •GA in either eye due to causes other than AMD
- •Previous treatment with eculizumab, lampalizumab, and/or fenretinide
Arms & Interventions
Lampalizumab once in every 4 weeks (Q4W)
Participants will receive 10 mg (milligrams) dose of lampalizumab by intravitreal injection, Q4W, starting at the Day 1 visit for approximately 92 weeks.
Intervention: Lampalizumab (Drug)
Lampalizumab once in every 6 weeks (Q6W)
Participants will receive 10 mg dose of lampalizumab by intravitreal injection, Q6W, starting at the Day 1 visit for approximately 90 weeks.
Intervention: Lampalizumab (Drug)
Sham Comparator
Participants will receive sham comparator, Q4W, starting at the Day 1 visit for approximately 92 weeks or Q6W, starting at the Day 1 visit for approximately 90 weeks.
Intervention: Sham Comparator (Other)
Outcomes
Primary Outcomes
Change From Baseline in Geographic Atropy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48
Time Frame: Baseline, Week 48
The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48
Time Frame: Baseline, Week 48
For CFI profile, positive or negative biomarker status refers to the presence (carrier) or absence of the risk allele at CFI and at least one risk allele at complement factor H (CFH) or risk locus containing both complement component 2 and complement factor B (C2/CFB).The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
Secondary Outcomes
- Change From Baseline in Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48(Baseline, Week 48)
- Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score at Week 48(Baseline, Week 48)
- Change From Baseline in NEI VFQ-25 Distance Activity Subscale Score at Week 48(Baseline, Week 48)
- Change From Baseline in Number of Absolute Scotomatous Points Assessed by Mesopic Microperimetry at Week 48(Baseline, Week 48)
- Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week 48(Week 48)
- Percentage of Participants With Less Than 15 Letters Loss From Baseline in LLVA Score at Week 48(Week 48)
- Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Week 48(Baseline, Week 48)
- Change From Baseline in Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions at Week 48(Baseline, Week 48)
- Change From Baseline in Mean Functional Reading Independence (FRI) Index at Week 48(Baseline, Week 48)
- Change From Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Charts or Radner Reading Charts at Week 48(Baseline, Week 48)
- Change From Baseline in Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts at Week 48(Baseline, Week 48)
- Change From Baseline in NEI VFQ-25 Near Activity Subscale Score at Week 48(Baseline, Week 48)