NCT07441642RecruitingPhase 2
A Study to Investigate Efficacy and Safety of FWY003 Compared With Placebo in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
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
Source: ClinicalTrials.gov · Last updated 9 Nov 2026
Brief summary (registry, in English)
To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 272 (estimated)
- First submitted
- 24 Feb 2026
- Start date
- 9 Mar 2026
- Primary completion date
- 21 Aug 2029
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Macular degeneration
- NCT number
- NCT07441642
- EU CT number
- 2025-523704-77-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 272
- From 9 Mar 2026 to the primary completion date, 21 Aug 2029
- 68 sites in 19 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
AI-kivonat: who the study is looking for
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 10 Nov 2026.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (68)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - | CABA | Argentina | Recruiting |
| - | Rosario | Argentina | Recruiting |
| - | Albury | Australia | Recruiting |
| - | East Melbourne | Australia | Recruiting |
| - | Parramatta | Australia | Recruiting |
| - | Strathfield | Australia | Recruiting |
| Multispecialty hospital for active treatment Sveta Sofia EOOD | Sofiya | Bulgaria | Recruiting |
| - | Blumenau | Brazil | Recruiting |
| - | Serra | Brazil | Recruiting |
| - | London | Canada | Recruiting |
| - | Ottawa | Canada | Recruiting |
| - | Shanghai | China | Recruiting |
| - | Barranquilla | Colombia | Recruiting |
| - | Medellín | Colombia | Recruiting |
| Fakultni nemocnice Kralovske Vinohrady | Prague | Czechia | Recruiting |
| Vseobecna fakultni nemocnice v Praze | Prague | Czechia | Recruiting |
| Universitaetsklinikum Bonn AöR | Bonn | Germany | Recruiting |
| Klinikum der Stadt Ludwigshafen am Rhein gGmbH | Ludwigshafen Am Rhein | Germany | Recruiting |
| Augenzentrum Am St Franziskus-Hospital Muenster | Munster | Germany | Recruiting |
| Universitaetsklinikum Tuebingen AöR | Tuebingen | Germany | Recruiting |
| Oftalmologia Vistahermosa S.L. | Burjassot | Spain | Recruiting |
| Metavision Arruzafa S.L. | Cordoba | Spain | Recruiting |
| Hospital Universitari General de Catalunya | Sant Cugat del Vallès | Spain | Recruiting |
| Instituto Oftalmologico Gomez-Ulla S.L. | Santiago De Compostela | Spain | Recruiting |
| Centre Hospitalier Intercommunal Creteil | Creteil Cedex | France | Recruiting |
| Centre Hospitalier Universitaire de Dijon | Dijon | France | Recruiting |
| Hospices Civils De Lyon | Lyon Cedex 04 | France | Recruiting |
| Fondation A. de Rothschild | Paris | France | Recruiting |
| Retina | Saint-Cyr-Sur-Loire | France | Recruiting |
| - | Bristol | United Kingdom | Recruiting |
| - | London | United Kingdom | Recruiting |
| - | Newcastle upon Tyne | United Kingdom | Recruiting |
| - | Southampton | United Kingdom | Recruiting |
| Central Hospital Of Northern Pest Military Hospital | Budapest VI | Hungary | Recruiting |
| Semmelweis University | Budapest VIII | Hungary | Recruiting |
| Budapest Retina Associates Kft. | Budapest XIII | Hungary | Recruiting |
| University of Debrecen | Debrecen | Hungary | Recruiting |
| Nozologen Kft. | Pécs | Hungary | Recruiting |
| Azienda Ospedaliero-Universitaria Careggi | Florence | Italy | Recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milan | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. | Milan | Italy | Recruiting |
| Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia | Rome | Italy | Recruiting |
| - | Amagasaki | Japan | Recruiting |
| - | Bunkyo Ku | Japan | Recruiting |
| - | Chiyoda-ku | Japan | Recruiting |
| - | Kobe | Japan | Recruiting |
| OFTALMIKA Sp. z o.o | Bydgoszcz | Poland | Recruiting |
| Centrum Medyczne Dietla 19 Sp. z o.o. | Cracow | Poland | Recruiting |
| Caminomed Sp. z o.o. | Tarnowskie Góry | Poland | Recruiting |
| Emanuelli Research and Development Center, LLC | Arecibo | Puerto Rico | Recruiting |
| Arensia Clinics S.R.L. | Bucharest | Romania | Recruiting |
| Spitalul Clinic Judetean De Urgenta Cluj | Cluj-Napoca | Romania | Recruiting |
| Retina Consultants TX Rsrch Ctr | Bellaire | United States | Recruiting |
| Opthamalic Consultants of Boston | Boston | United States | Recruiting |
| Advanced research, LLC | Boynton Beach | United States | Recruiting |
| Advanced Research LLC | Deerfield Beach | United States | Recruiting |
| Erie Retina Research LLC | Erie | United States | Recruiting |
| Retina Consultants of Houston PA | Houston | United States | Recruiting |
| Salehi Retina Institute | Huntington Beach | United States | Recruiting |
| Retina Consultants of Texas | Katy | United States | Recruiting |
| Retina Associates New Orleans | Metairie | United States | Recruiting |
| New York Eye and Ear Infirmary of Mount Sinai | New York | United States | Recruiting |
| Columbia University Medical Center | New York | United States | Recruiting |
| Mid Atlantic Retina | Philadelphia | United States | Recruiting |
| Retinal Consultants Medical Group, Inc. | Sacramento | United States | Recruiting |
| California Retina Consultants | Santa Barbara | United States | Recruiting |
| Retina Vitreous Associates of Florida | St. Petersburg | United States | Recruiting |
| NJ Retina | Toms River | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.