FWY003 in Geographic Atrophy Secondary to Age-Related Macular Degeneration in Patients

2 1

What is this study about?

This clinical trial is studying geographic atrophy, a form of eye damage that can happen with age-related macular degeneration. The treatment being tested is FWY003, taken by mouth as a capsule. Some participants will receive placebo instead. The purpose of the study is to see how different doses of FWY003 may affect the eye disease and to check its safety.

The study will compare FWY003 with placebo in people with this eye condition. It is a randomized study, which means the treatment is assigned by chance, and double masked, which means neither the participants nor the study team know who receives FWY003 or placebo during the study. Over time, the study follows changes in the damaged area in the eye and also watches for side effects and other health changes. The study lasts for many months and includes regular visits during which eye health and general well-being are reviewed.

Who Can Join the Study?

  • Be a man or woman who is 50 years of age or older.
  • Have a diagnosis of geographic atrophy secondary to age-related macular degeneration in at least one eye. Geographic atrophy means an area of damage or thinning in the back part of the eye, and age-related macular degeneration is an eye condition that affects central vision.
  • For the eye that will be studied, the total size of the geographic atrophy area, measured with a special eye scan called FAF (fundus autofluorescence, a picture that helps show damaged areas in the retina), must be at least 2.5 mm² and no more than 17.5 mm².
  • If the geographic atrophy is made up of more than one separate area, the total combined size must still be between 2.5 mm² and 17.5 mm², and at least one separate area must be at least 1.25 mm².
  • The entire geographic atrophy area must be visible on the eye image centered on the macula (the central part of the retina that helps with sharp, straight-ahead vision).
  • The geographic atrophy area must not touch peripapillary atrophy, which means thinning or damage around the optic nerve area at the back of the eye.
  • The study eye must have best-corrected visual acuity of at least 35 letters on the ETDRS chart, which is an eye chart used to measure vision, equal to about 20/200 vision or better.

Who Cannot Join the Study?

  • Any choroidal neovascularization in either eye, meaning new abnormal blood vessels under the retina, or current signs of this condition at screening.
  • Any exudative macular neovascularization in either eye, meaning leaking abnormal blood vessels in the macula, the central part of the retina needed for sharp vision.
  • Use of a complement inhibitor by injection into the eye in either eye within the past 3 months, or within 5 drug half-lives from screening, whichever is longer. A complement inhibitor is a medicine that blocks part of the immune system.
  • Having received 6 or more doses of an injected anti-complement treatment in the study eye.
  • Any previous cell therapy or gene therapy in either eye. Cell therapy uses living cells as treatment, and gene therapy changes genes to treat disease.
  • Macular atrophy in either eye caused by a condition other than age-related macular degeneration, such as Stargardt disease, cone rod dystrophy, or toxic maculopathies. Macular atrophy means loss or thinning of tissue in the macula.
  • Eye surgery in the study eye within 3 months before the starting visit, including cataract surgery or vitreoretinal surgery. Cataract surgery removes the cloudy lens, and vitreoretinal surgery is surgery inside the eye involving the retina and vitreous gel.
  • Any significant problem that makes it hard to see the back of the eye clearly or may affect image quality, such as cloudy eye tissue, nystagmus (uncontrolled eye movements), severe drooping of the eyelid, limited eye movement, or head tremor.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Centre Hospitalier Intercommunal Creteil Creteil France
Spitalul Clinic Judetean De Urgenta Cluj Cluj Napoca Romania

Other Sites

Site Name City Country Status
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
Hospital Universitari General De Catalunya Sant Cugat Del Valles Spain
Klinikum der Stadt Ludwigshafen am Rhein gGmbH Ludwigshafen Am Rhein Germany
Retina Saint-Cyr-Sur-Loire France
Augenzentrum Am St Franziskus-Hospital Muenster Munster Germany
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia Rome Italy
Nozologen Kft. Pecs Hungary
Instituto Oftalmologico Gomez-Ulla S.L. Santiago De Compostela Spain
Oftalmologia Vistahermosa S.L. Burjassot Spain
Fondation A De Rothschild Paris France
University Of Debrecen Debrecen Hungary
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Ospedale San Raffaele S.r.l. Milan Italy
Semmelweis University Budapest Hungary
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Centre Hospitalier Lyon Sud Pierre Benite France
Multispecialty hospital for active treatment Sveta Sofia EOOD Sofia Bulgaria
Budapest Retina Associates Budapest Hungary
Oftalmika Sp. z o.o. Bydgoszcz Poland
Metavision Arruzafa S.L. Cordoba Spain
Arhzfcq Cvznqmu Swohfu Bucharest Romania
Ccxwvez Maldijeg Dlawux 1a Sbk z oinl Cracow Poland
Cmjrmpkig Sgo z omab Tarnowskie Gory Poland
Cqthru Haubjyfutpb Uctzzfjhsstzw Dj Dntbd Dijon France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not yet recruiting
26.05.2026
Czechia Czechia
Recruiting
26.05.2026
France France
Recruiting
26.05.2026
Germany Germany
Not yet recruiting
26.05.2026
Hungary Hungary
Not yet recruiting
26.05.2026
Italy Italy
Not yet recruiting
26.05.2026
Poland Poland
Not yet recruiting
26.05.2026
Romania Romania
Recruiting
26.05.2026
Spain Spain
Recruiting
26.05.2026

Trial locations

FWY003 is the study medicine being tested in this trial. It is taken by mouth as a capsule. The goal of the study is to see whether FWY003 can help slow the growth of geographic atrophy lesions in people with age-related macular degeneration, and to check how safe it is and how well it works.

Geographic atrophy secondary to age-related macular degeneration – A form of age-related macular degeneration in which areas of the central retina gradually waste away. It usually develops slowly, with patches of damaged tissue becoming larger over time. As the affected area expands, central vision can become more affected, and nearby retinal layers may also thin.

Trial ID:
2025-523704-77-00
Protocol code:
CFWY003A12201
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Study of ONL1204 eye injections to slow vision loss in patients with age-related macular degeneration and geographic atrophy

    Recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Austria Czechia Germany Greece Hungary Italy +3
  • Study on the Effectiveness and Safety of GAL-101 Eye Drops for Patients with Geographic Atrophy from Age-Related Macular Degeneration

    Recruiting

    2 1
    France Germany Ireland Italy