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

NCT07230834 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: R3918-AMD-25012025-521758-40-00
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 5

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)

Keywords

Age-related Macular Degeneration (AMD); GA secondary to AMD

Outcome Measures

Primary Outcomes (4)

• Occurrence of ocular Treatment-Emergent Adverse Event (TEAEs) in the study eye

  Part A

  Through week 8

• Occurrence of ocular TEAEs in the study eye

  Part B

  Through week 16

• Occurrence of systemic TEAEs

  Part A

  Through week 8

• Occurrence of systemic TEAEs

  Part B

  Through week 16

Secondary Outcomes (6)

• Concentrations of pozelimab in serum

  Through week 8

• Concentrations of pozelimab in serum

  Through week 16

• Occurrence of Anti-Drug Antibody (ADA) to pozelimab

  Through week 8

• Magnitude of ADA to pozelimab

  Through week 8

• Occurrence of ADA to pozelimab

  Through week 16

Study Arms (2)

Part A

EXPERIMENTAL

Drug: Pozelimab

Part B

EXPERIMENTAL

Drug: Pozelimab

Interventions

Pozelimab DRUG

Administered per the protocol

Also known as: REGN3918

Part A; Part B

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study eye with diagnosis of GA of the macula secondary to AMD, as determined by the investigator
• 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
• 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

You may not qualify if:

• GA (macular atrophy) in either eye due to causes other than dry AMD
• History or current evidence of macular neovascularization and/or retinal exudation in either eye
• Concurrent eye disease (elevated Intraocular Pressure (IOP) \>25mm Hg, diabetic retinopathy, ocular infections/inflammation)
• 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
• Any prior systemic treatment for dry AMD, except oral supplements or vitamins
• History or current use of systemic complement inhibitor therapy

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (5)

Colorado Retina Associates

Lakewood, Colorado, 80228, United States

RECRUITING

Ophthalmic Consultants of Boston

East Weymouth, Massachusetts, 02189, United States

RECRUITING

Austin Retina Associates

Austin, Texas, 78705, United States

RECRUITING

Retina Foundation of the Southwest

Dallas, Texas, 75231, United States

RECRUITING

Retina Consultants Texas

The Woodlands, Texas, 77384, United States

RECRUITING

MeSH Terms

Conditions

Geographic Atrophy; Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part A will not be masked (Open label) and part B is masked
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: January 19, 2026
• Primary Completion (Estimated): July 3, 2028
• Study Completion (Estimated): July 3, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

US (5)