Actively Recruiting
A Phase 1 Dose-Escalation and Repeated-Dose Study of Safety and Tolerability of Intravitreal Pozelimab in Adults With Geographic Atrophy
Led by Regeneron Pharmaceuticals · Updated on 2026-05-28
54
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying an experimental drug called pozelimab, given as an injection into the eye, for people with geographic atrophy (GA), a condition where parts of the retina stop working over time, causing vision difficulties. The main goal is to evaluate how safe and tolerable pozelimab is when used in the eye. The study also examines possible side effects, how much pozelimab is present in the blood and eye fluid over time, and whether the body develops antibodies against the drug that might affect its use. Participants will receive pozelimab injections according to the study protocol during two parts of the trial. The study is randomized and uses a quadruple masking design to carefully assess safety and drug effects. There are dose-escalation and repeated-dose phases to monitor different dosing schedules and responses. The trial runs through multiple weeks, including assessments at 8 and 16 weeks. During the study, participants will be closely monitored for eye-related and systemic side effects. Researchers will measure drug levels in the blood and check for antibodies against pozelimab at set times. Visual acuity and retinal health will be evaluated using standardized tests. Safety monitoring and follow-up visits will continue through the study period, which lasts at least 16 weeks. The trial is sponsored by Regeneron Pharmaceuticals and is designed for adults aged 50 and older with GA secondary to age-related macular degeneration.
CONDITIONS
Brief Title
Intravitreal (IVT) Pozelimab for Geographic Atrophy (GA) in Adult Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Study eye diagnosed with geographic atrophy (GA) of the macula due to age-related macular degeneration (AMD)
- GA area in the study eye measuring about one disc area or larger (2.5 mm² or more) at screening
- Best-corrected visual acuity (BCVA) of 60 letters or worse on the Early Treatment Diabetic Retinopathy Score (ETDRS) chart (about 20/63 vision or worse) in the study eye at screening and baseline
You will not qualify if you...
- GA caused by reasons other than dry AMD in either eye
- History or current signs of macular neovascularization or retinal fluid in either eye
- Other eye diseases such as high intraocular pressure over 25 mm Hg, diabetic retinopathy, or eye infections/inflammation
- Prior or current intravitreal (eye) treatments in either eye, except complement inhibitor therapy for GA if last dose was at least 3 months before screening
- Any previous systemic treatment for dry AMD except vitamins or supplements
- History or current use of systemic complement inhibitor therapy
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 16 weeks
Participants receive intravitreal injections of Pozelimab as per the study protocol to evaluate safety and tolerability.
Trial Site Locations
Total: 7 locations
1
Colorado Retina Associates
Lakewood, Colorado, United States, 80228
Actively Recruiting
2
Ophthalmic Consultants of Boston
East Weymouth, Massachusetts, United States, 02189
Actively Recruiting
3
Austin Retina Associates
Austin, Texas, United States, 78705
Actively Recruiting
4
Retina Foundation of the Southwest
Dallas, Texas, United States, 75231
Actively Recruiting
5
Retina Consultants Texas
The Woodlands, Texas, United States, 77384
Actively Recruiting
6
ARENSIA Clinics SRL
Bucharest, Romania, 011658
Actively Recruiting
7
Arensia Exploratory Medicine Clinic at Country Hospital Cluj-Napoca
Cluj-Napoca, Romania, 400006
Actively Recruiting
Research Team
C
Clinical Trials Administrator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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