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

  • STATUS
    Recruiting
  • End date
    Jun 1, 2023
  • sponsor
    IVERIC Bio, Inc.
Updated on 24 June 2021

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).

Description

Patients will be randomized in a 1:1 ratio to the following monthly treatment groups:
  1. Zimura 2 mg
  2. Sham
At month 12, the patients in the Zimura 2mg treatment group will be re-randomized to receive the study drug either on a monthly basis or on an every other month basis.
The patients initially randomized to Sham treatment will continue with monthly Sham injections through Month 23.
All patients will have a final follow up visit at Month 24.

Details
Condition Macular Degeneration, Geographic Atrophy
Clinical Study IdentifierTX273657
SponsorIVERIC Bio, Inc.
Last Modified on24 June 2021

Eligibility

Yes No Not Sure

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
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