Tests FWY003 against placebo in people with geographic atrophy from macular degeneration
Tests FWY003 or placebo in adults over 50 with macular degeneration-related geographic atrophy.
Plain-language title generated from the registry record
Registry title: A Study to Investigate Efficacy and Safety of FWY003 Compared With Placebo in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
Key facts
- Where
- Florence, Milan, and Rome, ItalySee the 4 sites
- Phase
- Phase 2
Where in Italy
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyTaking people
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
- Fondazione G.B.Bietti Per Lo Studio E La Ricerca In OftalmologiaRome, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT07441642EU 2025-523704-77-00
- Record updated
- 9 November 2026
- Original description
To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).Read full original descriptionShow less
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
To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Inclusion: 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.
Exclusion: Previous cell or gene therapy in either eye; Intraocular surgery, including cataract and vitreoretinal surgery, in the study eye within 3 months prior to Baseline; A history of, or current evidence of, choroidal neovascularization (exudative MNV) in the study eye; Macular atrophy in either eye due to a cause other than AMD, such as Stargardt disease, cone rod dystrophy, toxic maculopathies, etc; 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.