Trials / Completed
CompletedNCT05811351
A Study to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 305 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate change in geographic atrophy (GA) lesion growth of eyes treated with JNJ-81201887 compared to sham control.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JNJ-81201887 | JNJ-81201887 will be administered as intravitreal injection. |
| DRUG | Prednisone | Prednisone will be administered as oral capsule. |
| OTHER | Placebo | Prednisone matching placebo will be administered as oral capsule. |
| DRUG | Triamcinolone | Triamcinolone (corticosteroid injection) periocular injection will be administered as per local practice. |
| OTHER | Sham Procedure | Sham injections matching to single JNJ-81201887 injection and matching to corticosteroid (triamcinolone) periocular injection will be administered. |
Timeline
- Start date
- 2023-03-06
- Primary completion
- 2026-02-23
- Completion
- 2026-02-23
- First posted
- 2023-04-13
- Last updated
- 2026-03-13
Locations
162 sites across 17 countries: United States, Australia, Belgium, Canada, Czechia, Denmark, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05811351. Inclusion in this directory is not an endorsement.