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

Regeneron Pharmaceuticals

Status and phase: Enrolling; Phase 1

Conditions: Geographic Atrophy (GA)

Treatments: Drug: Pozelimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07230834

2025-521758-40-00 (EU Trial (CTIS) Number)

R3918-AMD-2501

Details and patient eligibility

About

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)

Enrollment: 54 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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54 participants in 2 patient groups

Part A

Experimental group

Treatment:

Drug: Pozelimab

Part B

Experimental group

Treatment:

Drug: Pozelimab