A Randomized, Double Masked, Placebo-controlled, Multicenter, Dose-range Finding Study to Assess the Efficacy and Safety of FWY003 in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration
Status: Recruiting
Location: See all (33) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
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∙ Male or female participants ≥ 50 years of age.
• 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
• ETDRS BCVA ≥ 35 letters (20/200) in the study eye.