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

• Status: Active, not recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IVERIC bio, Inc.

Criteria

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