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
- Creteil Cedex, Dijon, Lyon Cedex 04, Paris, and Saint-Cyr-Sur-Loire, FranceSee the 5 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 50 or older with geographic atrophy, an eye disease from age-related macular degeneration (AMD), in at least one eye. It compares FWY003 with a placebo.
- Age
- 50 years or older
- Sex
- Men and women can both join.
- Disease stage
- Geographic atrophy secondary to AMD in at least one eye (the study eye). Total lesion area must be ≥2.5 and ≤17.5 mm2. A multifocal lesion needs at least one lesion of 1.25 mm2 or more. The whole lesion must be visible on the macula-centered image and not touch peripapillary atrophy.
- Earlier treatment
- People with previous cell or gene therapy in either eye cannot join. Eye surgery in the study eye within 3 months before baseline is also not allowed.
- Biomarker or test result
- Vision in the study eye must be ETDRS BCVA ≥ 35 letters (20/200).
Main reasons for not taking part
- Current or past choroidal neovascularization (exudative MNV) in the study eye
- Previous cell or gene therapy in either eye
- Macular atrophy in either eye from a cause other than AMD, such as Stargardt disease or cone rod dystrophy
- Intraocular surgery (including cataract or vitreoretinal) in the study eye within 3 months before baseline
- Significant media opacity, nystagmus, severe ptosis, eye movement restriction or head tremor that would prevent good eye imaging
Read by machine on 12 November 2026.
Where in France
- Centre Hospitalier Intercommunal CreteilCreteil Cedex, FranceTaking people
- Centre Hospitalier Universitaire de DijonDijon, FranceTaking people
- Hospices Civils De LyonLyon Cedex 04, FranceTaking people
- Fondation A. de RothschildParis, FranceTaking people
- RetinaSaint-Cyr-Sur-Loire, FranceTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.