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

A Phase 1 Dose-Escalation and Repeated-Dose Study of the Safety and Tolerability of Intravitreal Pozelimab in Participants With Geographic Atrophy

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)

Study Overview

• Status: Recruiting
• Conditions: Geographic Atrophy (GA)
• Intervention / Treatment: Drug: Pozelimab

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Clinical Trials Administrator; Phone Number: 844-734-6643; Email: clinicaltrials@regeneron.com

Study Locations

• United States
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Recruiting
      • Colorado Retina Associates
  • Massachusetts
    • East Weymouth, Massachusetts, United States, 02189
      • Recruiting
      • Ophthalmic Consultants of Boston
  • Texas
    • Austin, Texas, United States, 78705
      • Recruiting
      • Austin Retina Associates
    • Dallas, Texas, United States, 75231
      • Recruiting
      • Retina Foundation of the Southwest
    • The Woodlands, Texas, United States, 77384
      • Recruiting
      • Retina Consultants Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A	Drug: Pozelimab; Administered per the protocol; Other Names: REGN3918
Experimental: Part B	Drug: Pozelimab; Administered per the protocol; Other Names: REGN3918

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentrations of pozelimab in serum	Part A	Through week 8
Concentrations of pozelimab in serum	Part B	Through week 16
Occurrence of Anti-Drug Antibody (ADA) to pozelimab	Part A	Through week 8
Magnitude of ADA to pozelimab	Part A	Through week 8
Occurrence of ADA to pozelimab	Part B	Through week 16
Magnitude of ADA to pozelimab	Part B	Through week 16

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2026
• Primary Completion (Estimated): July 3, 2028
• Study Completion (Estimated): July 3, 2028

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Age-related Macular Degeneration (AMD); GA secondary to AMD
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration; Geographic Atrophy
• Other Study ID Numbers: R3918-AMD-2501; 2025-521758-40-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

IPD Sharing 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

• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No