Intravitreal (IVT) Pozelimab for Geographic Atrophy (GA) in Adult Participants
Purpose
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)
Condition
- Geographic Atrophy (GA)
Eligibility
- Eligible Ages
- Over 50 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Part A will not be masked (Open label) and part B is masked
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part A |
|
|
|
Experimental Part B |
|
Recruiting Locations
Colorado Retina Associates
Lakewood 5427946, Colorado 5417618 80228
Lakewood 5427946, Colorado 5417618 80228
Austin Retina Associates
Austin 4671654, Texas 4736286 78705
Austin 4671654, Texas 4736286 78705
More Details
- NCT ID
- NCT07230834
- Status
- Recruiting
- Sponsor
- Regeneron Pharmaceuticals