Recruiting
Phase 1

Pozelimab

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT07230834

Conditions

Geographic Atrophy (GA)

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Pozelimab

Study Details

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 ID

NCT07230834

Start date

Jan 19, 2026

Status verified date

Mar, 2026

Completion date

Jul 3, 2028

Anticipated

Primary completion date

Jul 3, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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 Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A

experimental: Part B

Interventions

Pozelimab

Administered per the protocol

Primary outcome measure

  • Occurrence of ocular Treatment-Emergent Adverse Event (TEAEs) in the study eye [ Time Frame: Through week 8 ]
  • Occurrence of ocular TEAEs in the study eye [ Time Frame: Through week 16 ]
  • Occurrence of systemic TEAEs [ Time Frame: Through week 8 ]
  • Occurrence of systemic TEAEs [ Time Frame: Through week 16 ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Colorado Retina Associates

Recruiting

Lakewood, Colorado, United States, 80228

Ophthalmic Consultants of Boston

Recruiting

East Weymouth, Massachusetts, United States, 02189

Austin Retina Associates

Recruiting

Austin, Texas, United States, 78705

Retina Foundation of the Southwest

Recruiting

Dallas, Texas, United States, 75231

Retina Consultants Texas

Recruiting

The Woodlands, Texas, United States, 77384

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Aug 5, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-08-05.