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Recruiting NCT07230834

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

Phase I Interventional Geographic Atrophy (GA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pozelimab.
Who it may be relevant to
Registry conditions: Geographic Atrophy (GA). Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Georgia, Puerto Rico, Romania
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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)

Interventions

  • Drug Pozelimab
    Administered per the protocol

Primary outcome measures

  • 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]
Secondary outcome measures (6)
  • Concentrations of pozelimab in serum [Time frame: Through week 8]
  • Concentrations of pozelimab in serum [Time frame: Through week 16]
  • Occurrence of Anti-Drug Antibody (ADA) to pozelimab [Time frame: Through week 8]
  • Magnitude of ADA to pozelimab [Time frame: Through week 8]
  • Occurrence of ADA to pozelimab [Time frame: Through week 16]
  • Magnitude of ADA to pozelimab [Time frame: Through week 16]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 5 centers
  • Colorado Retina Associates — Lakewood
  • Ophthalmic Consultants of Boston — East Weymouth
  • Austin Retina Associates — Austin
  • Retina Foundation of the Southwest — Dallas
  • Retina Consultants Texas — The Woodlands
Romania · 2 centers
  • ARENSIA Clinics SRL — Bucharest
  • Arensia Exploratory Medicine Clinic at Country Hospital Cluj-Napoca — Cluj-Napoca
Georgia · 1 center
  • Arensia Exploratory Medicine at the Research Institute of Clinical Medicine — Tbilisi
Puerto Rico · 1 center
  • Emanuelli Research and Development Center — Arecibo

Identifiers

NCT: NCT07230834 · R3918-AMD-2501 · 2025-521758-40-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗