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
Novartis Pharmaceuticals
Summary
To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Description
This study is designed as a randomized, multi-center, double-masked, prospective study to characterize the dose response relationship, efficacy and safety of FWY003.
Eligibility
- Age range
- 50+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 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. 1. Total GA area must be ≥2.5 and ≤17.5 mm2 (1 and 7 disk areas (DA), respectively) 2. 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 3. Entire GA lesion must be visualized on the macula centered image and not contiguous with peripapillary atrophy * ETDRS BCVA ≥ 3…
Interventions
- DrugFWY003
FWY003 arm participants will receive a specific dose of FWY003
- DrugPlacebo
Placebo arm participants will receive placebo
Locations (14)
- Salehi Retina InstituteHuntington Beach, California
- Retinal Consultants Medical Group IncSacramento, California
- Advanced Research LLCBoynton Beach, Florida
- Advanced Research LLCDeerfield Beach, Florida
- Retina Vitreous Associates of FloridaSt. Petersburg, Florida
- Opthamalic Consultants of BostonBoston, Massachusetts