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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
AAVCAGsCD59 is administered as an intravitreal injection in the enrolled eye
Sham injection mimics a real injection in the enrolled eye
Evaluate the change in Geographic Atrophy area (mm2) measured at Day 0 and compared to the measurement at Month 24
Geographic atrophy will be measured based on imaging of the retina
Time frame: 24 Months
Incidence of conversion from dry to wet age-related macular degeneration
Measure the number of treated eyes in the sham and AAVCAGsCD59-treated arms that convert from dry to wet age-related macular degeneration
Time frame: 24 Months
Change in visual acuity of the AAVCAGsCD59 treated eye
Visual acuity measured on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart will be compared at Day 0 and Month 24
Time frame: 24 Months
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