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

NCT ID: NCT07230834

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-22
• Study Completion Date: 2028-07-10

Brief 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)

Conditions

Geographic Atrophy (GA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part A

Group Type: EXPERIMENTAL

Pozelimab

Intervention Type: DRUG

Administered per the protocol

Part B

Group Type: EXPERIMENTAL

Pozelimab

Intervention Type: DRUG

Administered per the protocol

Interventions

Pozelimab

Administered per the protocol

Intervention Type: DRUG

Other Intervention Names

REGN3918

Eligibility Criteria

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

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Colorado Retina Associates

Lakewood, Colorado, United States

Site Status: RECRUITING

Austin Retina Associates

Austin, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clinical Trials Administrator

Role: CONTACT

clinicaltrials@regeneron.com

844-734-6643

Other Identifiers

2025-521758-40-00

Identifier Type: CTIS

Identifier Source: secondary_id

R3918-AMD-2501

Identifier Type: -

Identifier Source: org_study_id