Vamikibart in Participants With Uveitic Macular Edema

Phase 3

Active, not recruiting

• Conditions: Uveitic Macular Edema
• Interventions: Drug: Vamikibart; Other: Sham

• Registration Number: NCT05642325
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This study will assess the efficacy and safety of vamikibart in participants with uveitic macular edema.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-06
• Study First Submitted QC: 2022-12-06
• Study First Posted: 2022-12-08
• Study Start: 2023-03-23
• Status Verified: 2025-05
• Primary Completion: 2025-05-07
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Study Completion: 2025-12-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

• Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocol
• Diagnosis of macular edema associated with non-infectious uveitis (NIU)
• Diagnosis of active or inactive, acute, or chronic NIU of any etiology and of any anatomical type (anterior, intermediate, posterior, panuveitis)
• BCVA letter score of 73 to 19 letters (inclusive) on Early Treatment Diabetic Retinopathy Study (EDTRS)-like charts

Exclusion Criteria

• Evidence of active or latent syphilis infection
• Evidence of active or latent tuberculosis infection and/or positive tuberculosis assay, or previous or current HIV diagnosis
• Serious acute or chronic medical or psychiatric illness
• History of major ocular and non-ocular surgical procedures
• Uncontrolled IOP or glaucoma or chronic hypotony
• Any anatomical changes or media opacity in the study eye preventing evaluation of retina, vitreous, and capture of study images
• Prior use of IVT biologics including anti-VEGFs less than 2-4 months prior to Day 1; received IVT Methotrexate within 4 months prior to Day 1
• Prior macular laser therapy, cataract surgery within 6 months and laser capsulotomy within 3 months of Day 1
• Topical corticosteroids and/or topical NSAID > 3 drops per day in the 14 days prior to Day 1 (D1); intraocular or periocular corticosteroid injections in the 2 months prior to D1; subconjunctival corticosteroid injection within 1 month prior to Day 1; an OZURDEX implant in the 4 months prior to D1; YUTIQ, RETISERT or ILUVIEN implant in the 3 years prior to D1
• Diagnosis of macular edema due to any cause other than NIU
• Any major ocular conditions that may require medical or surgical intervention during the study period to prevent vision loss

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Vamikibart	Participants will receive 4 high-dose vamikibart intravitreal (IVT) injections every 4 weeks (Q4W) to Week 12, followed by as-needed (PRN) dosing from Week 20 to Week 48.
Arm B	Vamikibart	Participants will receive 4 low-dose vamikibart IVT injections Q4W to Week 12, followed by PRN dosing from Week 20 to Week 48.
Arm C	Sham	Participants will receive 4 sham injections Q4W to Week 12, followed by PRN sham dosing from Week 20 to Week 48.

Primary Outcome Measures

Name	Time	Method
Proportion of participants with ≥ 15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16	Week 16

Secondary Outcome Measures

Name	Time	Method
Number of rescue treatments received	Up to Week 52
Change from baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) at Weeks 16 and 52	Weeks 16 and 52
Change from Baseline in BCVA at Weeks 20 and 52	Weeks 20 and 52
Proportion of participants without ≥15 letter loss from baseline in BCVA at Week 16 and 52	Weeks 16 and 52
Percent change from baseline in corneal endothelial cell density at Week 24	Week 24
Percentage of participants with non-ocular AEs	Up to Week 52
Aqueous humor (AH) concentration of vamikibart	Up to Week 52
Change from baseline in BCVA at Week 16	Week 16
Change from baseline in central subfield thickness (CST) at Week 16	Week 16
Change from baseline in CST at Weeks 20 and 52	Weeks 20 and 52
Time to rescue treatment	Up to Week 52
Type of rescue treatments received	Up to Week 52
Percentage of participants with adverse events of special interest (AESIs)	Up to Week 52
Percent change from baseline in corneal endothelial cell density at Week 52	Week 52
Serum concentration of vamikibart	Up to Week 52
Proportion of participants with ≥ 15 letter improvement from baseline in BCVA at Week 20	Week 20
Proportion of participants with uveitic macular edema secondary to non-infectious uveitis (UME) resolution defined by standardized (by machine) CST threshold <325um on optical coherence tomography (OCT) from baseline at Weeks 16 and 52	Weeks 16 and 52
Proportion of participants with ≥15 letter improvement from baseline in BCVA at Week 16 and 52	Weeks 16 and 52
Time to first PRN injection	Up to Week 52
Percentage of participants with ocular adverse events (AEs)	Up to Week 52
Anti-drug antibody titer to vamikibart	Baseline to Week 52

Trial Locations

Locations (93)

Associated Retina Consultants; 🇺🇸 Phoenix, Arizona, United States

Barnet Dulaney Perkins Eye Center; 🇺🇸 Sun City, Arizona, United States

Retina Consultants of Orange County; 🇺🇸 Fullerton, California, United States

Northern California Retina Vitreous Associates; 🇺🇸 Mountain View, California, United States

California Eye Specialists Medical group Inc.; 🇺🇸 Pasadena, California, United States

Retina Consultants of Southern California; 🇺🇸 Redlands, California, United States

Kaiser Permanente Riverside Medical Center; 🇺🇸 Riverside, California, United States

University of California, Davis, Eye Center; 🇺🇸 Sacramento, California, United States

Retinal Consultants Med Group; 🇺🇸 Sacramento, California, United States

Advanced Research; 🇺🇸 Deerfield Beach, Florida, United States

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