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

  • STATUS
    Recruiting
  • participants needed
    400
  • sponsor
    IVERIC bio, Inc.
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Updated on 16 February 2024
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age-related macular degeneration
atrophy
geographic atrophy
macular degeneration
complement c5
maculopathy

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:

  • Zimura 2 mg
  • 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 Dry Macular Degeneration, age-related macular degeneration, macular degeneration, macular degeneration, geographic atrophy
Age 50years - 100years
Treatment Sham, Zimura
Clinical Study IdentifierNCT04435366
SponsorIVERIC bio, Inc.
Last Modified on16 February 2024

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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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age-related macular degeneration
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