Trials / Completed
CompletedNCT02686658
Zimura in Participants With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
A Phase 2/3 Randomized, Double-Masked, Controlled Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura™ (Anti-C5 Aptamer) in Patients With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 286 (actual)
- Sponsor
- IVERIC bio, Inc. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
The objectives of this study were to evaluate the safety and efficacy of Zimura intravitreal (IVT) administration when administered in participants with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).
Detailed description
Participants will receive monthly intravitreal injections of Zimura or Sham for 18 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Avacincaptad Pegol | Avacincaptad Pegol 20 mg/mL solution for intravitreal (IVT) injection |
| OTHER | Sham | The Sham procedure included the blunt opening of an empty, needleless syringe barrel placed on the conjunctiva in the inferotemporal quadrant of the eyeball to simulate the pressure of an injection. |
Timeline
- Start date
- 2015-12-15
- Primary completion
- 2019-09-26
- Completion
- 2020-04-23
- First posted
- 2016-02-19
- Last updated
- 2025-06-10
- Results posted
- 2023-05-11
Locations
78 sites across 7 countries: United States, Croatia, Czechia, Estonia, Hungary, Israel, Latvia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02686658. Inclusion in this directory is not an endorsement.