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A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)
Not Recruiting
Trial ID: NCT04435366
Purpose
The objectives of this study are to evaluate the safety and efficacy of Zimura (avacincaptad
pegol) intravitreal administration in patients with geographic atrophy secondary to
age-related macular degeneration (AMD)
Official Title
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
Stanford Investigator(s)
Diana Do, MD
Professor of Ophthalmology
Eligibility
Inclusion Criteria:
- Subjects of either gender aged ≥ 50 years
- Diagnosis of Non-foveal GA secondary to dry AMD
Exclusion Criteria:
- 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
Intervention(s):
drug: Sham
drug: Avacincaptad Pegol
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305