To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
A diagnosis of GA secondary to AMD in at least one eye (study eye). If both eyes qualify, then the eye with the better BCVA would be assigned as study eye.
Total GA area must be ≥2.5 and ≤17.5 mm2 (1 and 7 disk areas (DA), respectively)
If GA lesion is multifocal, then the total lesion area must be between 2.5-17.5 mm2 and at least one lesion should have an area of at least 1.25 mm2
Entire GA lesion must be visualized on the macula centered image and not contiguous with peripapillary atrophy
A history of, or current evidence of, choroidal neovascularization (exudative MNV) in the study eye.
Previous cell or gene therapy in either eye.
Macular atrophy in either eye due to a cause other than AMD, such as Stargardt disease, cone rod dystrophy, toxic maculopathies, etc.
Intraocular surgery, including cataract and vitreoretinal surgery, in the study eye within 3 months prior to Baseline.
Parallel
FWY003
DrugFWY003 arm participants will receive a specific dose of FWY003
Placebo
DrugPlacebo arm participants will receive placebo
Change of geographic atrophy (GA) lesion area in the study eye
To evaluate the dose response relationship of FWY003 on GA lesion area in the study eye in participants with GA secondary to age-related macular degeneration (AMD).
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
To assess the safety and tolerability of FWY003.
Change in visual function measure by ETDRS (Regular Luminance) Best Corrected Visual Acuity (BCVA) in the study eye
To assess the change in visual function over time by measuring Best Corrected Visual Acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart under normal lighting conditions. BCVA is the sharpest vision a person can achieve with optimal correction, such as glasses or contact lenses. The ETDRS eye chart is the standardized chart used in clinical trials.
Change in visual function measure by ETDRS Low Luminance Visual Acuity (LLVA) in the study eye
To assess the change in visual function using Early Treatment Diabetic Retinopathy Study (ETDRS) Low Luminance Visual Acuity (LLVA) vision test. This test measures how well a person can see under low-light conditions. It is performed using the standard ETDRS eye chart.
Change in visual function measure by Quantitative contrast sensitivity function (qCSF) under regular luminance in the study eye
To assess the change in visual function by using a test called the quantitative Contrast Sensitivity Function (qCSF). qCSF checks how faint a pattern a person can see, and how that changes for large vs. small details.
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