Geographic Atrophy (GA)
Conditions
Keywords
Age-related Macular Degeneration (AMD), GA secondary to AMD
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)
Interventions
DRUGPozelimab
Administered per the protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Part A will not be masked (Open label) and part B is masked
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of ocular Treatment-Emergent Adverse Event (TEAEs) in the study eye | Through week 8 | Part A |
| Occurrence of ocular TEAEs in the study eye | Through week 16 | Part B |
| Occurrence of systemic TEAEs | Through week 8 | Part A |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentrations of pozelimab in serum | Through week 8 | Part A |
| Occurrence of Anti-Drug Antibody (ADA) to pozelimab | Through week 8 | Part A |
| Magnitude of ADA to pozelimab | Through week 8 | Part A |
| Occurrence of ADA to pozelimab | Through week 16 | Part B |
Countries
Georgia, Puerto Rico, Romania, United States
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed