Trials / Completed
CompletedNCT04435366
A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)
A Phase 3 Multicenter, Randomized, Double Masked, Sham- Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura (Complement C5 Inhibitor) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 448 (actual)
- Sponsor
- IVERIC bio, Inc. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
The objectives of this study was to evaluate the safety and efficacy of avacincaptad pegol intravitreal administration in participants with geographic atrophy secondary to age-related macular degeneration (AMD)
Detailed description
Participants were randomized in a 1:1 ratio to the following monthly treatment groups: * Avacincaptad pegol 2 mg * Sham At Month 12, the participants in the avacincaptad pegol 2mg treatment group were re-randomized to receive the study drug either on a monthly basis or on an every other month basis The participants initially randomized to sham treatment continued with monthly sham administration through Month 23 All participants had a final follow up visit at Month 24
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Avacincaptad Pegol | Avacincaptad Pegol Intravitreal Injection |
| DRUG | Sham | Sham Administration (includes placement of the blunt opening of an empty, needleless syringe barrel on the conjunctiva in the inferotemporal quadrant of the eyeball to simulate the pressure of an injection) |
Timeline
- Start date
- 2020-06-22
- Primary completion
- 2022-07-25
- Completion
- 2023-08-22
- First posted
- 2020-06-17
- Last updated
- 2025-10-21
- Results posted
- 2023-12-28
Locations
205 sites across 20 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Croatia, Czechia, Estonia, France, Germany, Hungary, Israel, Italy, Latvia, Poland, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04435366. Inclusion in this directory is not an endorsement.