Last Update: Aug 20, 2026 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 ClinicalTrials.gov Identifier: [NCT07441642](https://clinicaltrials.gov/ct2/show/NCT07441642) Novartis Reference Number:CFWY003A12201 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). This study is designed as a randomized, multi-center, double-masked, prospective study to characterize the dose response relationship, efficacy and safety of FWY003. Condition Geographic Atrophy Secondary to Age-related Macular Degeneration Phase Phase2 Overall Status Recruiting Number of Participants272 Start Date Mar 09, 2026 Completion Date Aug 22, 2029 Gender All Age(s) 50 Years - (Adult, Older Adult) ## Interventions Drug ### FWY003 FWY003 arm participants will receive a specific dose of FWY003 Drug ### Placebo Placebo arm participants will receive placebo ## Eligibility Criteria 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 ≥ 35 letters (20/200) in the study eye. Exclusion Criteria: \* 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. \* Presence of significant media opacity, eye movement disorder (nystagmus), severe ptosis, extraocular motility restriction or head tremor, which in the opinion of the investigator, would prevent adequate fundus visualization or which in the opinion of the Reading Center could interfere with the assessment of study images. Other protocol-defined inclusion/exclusion criteria may apply. 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