Intravitreal AAVCAGsCD59 for Advanced Dry Age-related Macular Degeneration (AMD) With Geographic Atrophy (GA)
NCT04358471 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2021-05-10
Summary
Patients with advanced dry AMD with GA meeting inclusion criteria will be randomized in one eye in a 1:1:1 ratio comparing intravitreal high or low dose AAVCAGsCD59 with a sham injection. All enrolled subjects will be followed for 24 months to evaluate reduction in GA growth and safety of intravitreal AAVCAGsCD59.
Conditions
- Dry Age-related Macular Degeneration
- Geographic Atrophy
- Gene Therapy
- Intravitreal Injection
Interventions
- BIOLOGICAL
-
Intravitreal AAVCAGsCD59
AAVCAGsCD59 is administered as an intravitreal injection in the enrolled eye
- OTHER
-
Intravitreal Sham Injection
Sham injection mimics a real injection in the enrolled eye
Sponsors & Collaborators
-
Hemera Biosciences
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-07-31
- Primary Completion
- 2023-07-01
- Completion
- 2023-09-01
- FDA Drug
- Yes
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