Status:
COMPLETED
A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)
Lead Sponsor:
IVERIC bio, Inc.
Conditions:
Geographic Atrophy
Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief 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 degenera...
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 we...
Eligibility Criteria
Inclusion
- Subjects of either gender aged ≥ 50 years
- Diagnosis of Non-foveal GA secondary to dry AMD
Exclusion
- Any prior treatment for AMD (dry or wet) or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals
- Any intraocular surgery or thermal laser within 3 months of trial entry.
- Any prior thermal laser in the macular region, regardless of indication
- Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 12 weeks.
- Previous therapeutic radiation in the region of the study eye
- Any sign of diabetic retinopathy in either eye
Key Trial Info
Start Date :
June 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2023
Estimated Enrollment :
448 Patients enrolled
Trial Details
Trial ID
NCT04435366
Start Date
June 22 2020
End Date
August 22 2023
Last Update
October 21 2025
Active Locations (205)
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1
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
2
Retinal Diagnostic Center
Campbell, California, United States, 95008
3
Eye Medical Center of Fresno
Fresno, California, United States, 93720
4
Retina Consultants of Orange County
Fullerton, California, United States, 92835