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NCT07230834PHASE1Recruiting

Intravitreal (IVT) Pozelimab for Geographic Atrophy (GA) in Adult Participants

Regeneron Pharmaceuticals

Start Date

1/19/2026

Completion Date

7/3/2028

Summary

This study is researching an experimental drug called pozelimab (called "study drug"). The study is focused on people with a condition where certain parts of the eye's retina stop working over time, which can make it harder to see. This is called geographic atrophy (GA). The aim of the study is to see how safe and tolerable the study drug is when used as an injection in the eye. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood and the fluid in the eye at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Eligibility Criteria

Age Range: 50 years to No maximum

Key Inclusion Criteria: 1. Study eye with diagnosis of GA of the macula secondary to AMD, as determined by the investigator 2. Study eye with total GA area measuring approximately one disc area or greater in size (2.5 mm\^2 or larger) at screening, as determined by the Central Reading Center (CRC), as described in the protocol 3. Best-Corrected Visual Acuity (BCVA) of 60 letters or worse using the Early Treatment Diabetic Retinopathy Score (ETDRS) charts (Snellen equivalent of \~ ≤20/63) in the study eye at screening and baseline visit Key Exclusion Criteria: 1. GA (macular atrophy) in either eye due to causes other than dry AMD 2. History or current evidence of macular neovascularization and/or retinal exudation in either eye 3. Concurrent eye disease (elevated Intraocular Pressure (IOP) \>25mm Hg, diabetic retinopathy, ocular infections/inflammation) 4. Prior or current intravitreal (IVT) treatment of any kind for any indication in either the study or fellow eye, except complement inhibitor therapy for GA, as long as last dose was ≥3 months prior to screening 5. Any prior systemic treatment for dry AMD, except oral supplements or vitamins 6. History or current use of systemic complement inhibitor therapy Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Interventions

DRUG

Pozelimab

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Conditions

Geographic Atrophy (GA)

Locations

Colorado Retina Associates

Lakewood, Colorado 80228

United States

Ophthalmic Consultants of Boston

East Weymouth, Massachusetts 02189

United States

Austin Retina Associates

Austin, Texas 78705

United States

Retina Foundation of the Southwest

Dallas, Texas 75231

United States

Retina Consultants Texas

The Woodlands, Texas 77384

United States

Arensia Exploratory Medicine at the Research Institute of Clinical Medicine

Tbilisi, 0112

Georgia

ARENSIA Clinics SRL

Bucharest, 011658

Romania

Arensia Exploratory Medicine Clinic at Country Hospital Cluj-Napoca

Cluj-Napoca, 400006

Romania