A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)

Principal Investigator

Philip Rosenfeld

Enrollment Status

Not Accepting

Clinical Trial ID

Institutional Protocol # 20200925

National Clinical Trials Identifier NCT04435366

Clinical Trial Summary

The objectives of this study are to evaluate the safety and efficacy of Zimura intravitreal
administration in patients with geographic atrophy secondary to age-related macular
degeneration (AMD)

Phase

Phase 3

Funding Agency/Sponsor

Industry

Disease

Retina

Enrollment 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

Contact Information

Study Contact Philip Rosenfeld

Phone Number +1 (305) 3266148

Email prosenfeld@miami.edu

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