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NCT Number: NCT07230834

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

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)

Recruiting

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Key information

Conditions

Geographic Atrophy (GA) Eye Diseases Geographic Atrophy Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arensia Exploratory Medicine at the Research Institute of Clinical Medicine, Tbilisi, Georgia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Treatment and study plan

Pozelimab

Drug

Administered per the protocol

Other names: REGN3918

Primary outcomes

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

    Time frame: Through week 8

    Part A

  2. Occurrence of ocular TEAEs in the study eye

    Time frame: Through week 16

    Part B

  3. Occurrence of systemic TEAEs

    Time frame: Through week 8

    Part A

  4. Occurrence of systemic TEAEs

    Time frame: Through week 16

    Part B

Secondary outcomes

  1. Concentrations of pozelimab in serum

    Time frame: Through week 8

    Part A

  2. Concentrations of pozelimab in serum

    Time frame: Through week 16

    Part B

  3. Occurrence of Anti-Drug Antibody (ADA) to pozelimab

    Time frame: Through week 8

    Part A

  4. Magnitude of ADA to pozelimab

    Time frame: Through week 8

    Part A

  5. Occurrence of ADA to pozelimab

    Time frame: Through week 16

    Part B

  6. Magnitude of ADA to pozelimab

    Time frame: Through week 16

    Part B

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: VIENNA

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 17, 2025
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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