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

Study Overview
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Brief Summary
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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)

Detailed Description
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Participants will be randomized in a 1:1 ratio to the following monthly treatment groups: Avacincaptad pegol 2 mg Sham At Month 12, the participants in the avacincaptad pegol 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 participants initially randomized to sham treatment will continue with monthly sham administration through Month 23 All participants will have a final follow up visit at Month 24

Official Title
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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

Conditions
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Geographic Atrophy, Macular Degeneration

Intervention / Treatment
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* Drug: Avacincaptad Pegol
* Drug: Sham


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Avacincaptad Pegol Treatment Group<br>Monthly avacincaptad pegol 2mg intravitreal injections through Month 11 (Year 1) NOTE: At Month 12, participants are re-randomized to receive monthly injections or every other month injections (alternating with sham) from Month 12 to Month 23 (Year 2) - Year 2 is not included in the primary analysis. | Drug: Avacincaptad Pegol<br>* Avacincaptad Pegol Intravitreal Injection<br>* Other names: IZERVAY;|
| Sham Comparator: Sham Treatment Group<br>Monthly sham administration through Month 11 (Year 1) NOTE: At Month 12, participants continue to receive monthly sham administration from Month 12 to Month 23 (Year 2) - Year 2 is not included in the primary analysis. | Drug: Sham<br>* Sham Administration (includes placement of the blunt opening of an empty, needleless syringe barrel on the conjunctiva in the inferotemporal quadrant of the eyeball to simulate the pressure of an injection)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Rate of Change in GA Over 12 Months (Measured at Three Time Points: Baseline, Month 6, and Month 12) | The least squares mean rate of growth (slope) estimated based on geographic atrophy (GA) area measured by fundus autofluorescence (FAF) in at least 3 timepoints: Baseline, Month 6, and Month 12 was used to determine mean rate of change (slope) in GA from Baseline to Month 12. The square root of the GA area was used in the analysis. | Baseline and Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Geographic Atrophy (GA), Age-related Macular Degeneration, AMD, Zimura, Complement C5 inhibitor, avacincaptad pegol, IZERVAY