A Phase 1 Dose-Escalation and Repeated-Dose Study of the Safety and Tolerability of Intravitreal Pozelimab in Participants With Geographic Atrophy
Regeneron Pharmaceuticals
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)
Eligibility
- Age range
- 50+ years
- Sex
- All
- Healthy volunteers
- No
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 eith…
Interventions
- DrugPozelimab
Administered per the protocol
Locations (5)
- Colorado Retina AssociatesLakewood, Colorado
- Ophthalmic Consultants of BostonEast Weymouth, Massachusetts
- Austin Retina AssociatesAustin, Texas
- Retina Foundation of the SouthwestDallas, Texas
- Retina Consultants TexasThe Woodlands, Texas