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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

Next steps

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
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

Full criteria on ClinicalTrials.gov

Sites (68)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
-CABAArgentinaRecruiting
-RosarioArgentinaRecruiting
-AlburyAustraliaRecruiting
-East MelbourneAustraliaRecruiting
-ParramattaAustraliaRecruiting
-StrathfieldAustraliaRecruiting
Multispecialty hospital for active treatment Sveta Sofia EOODSofiyaBulgariaRecruiting
-BlumenauBrazilRecruiting
-SerraBrazilRecruiting
-LondonCanadaRecruiting
-OttawaCanadaRecruiting
-ShanghaiChinaRecruiting
-BarranquillaColombiaRecruiting
-MedellínColombiaRecruiting
Fakultni nemocnice Kralovske VinohradyPragueCzechiaRecruiting
Vseobecna fakultni nemocnice v PrazePragueCzechiaRecruiting
Universitaetsklinikum Bonn AöRBonnGermanyRecruiting
Klinikum der Stadt Ludwigshafen am Rhein gGmbHLudwigshafen Am RheinGermanyRecruiting
Augenzentrum Am St Franziskus-Hospital MuensterMunsterGermanyRecruiting
Universitaetsklinikum Tuebingen AöRTuebingenGermanyRecruiting
Oftalmologia Vistahermosa S.L.BurjassotSpainRecruiting
Metavision Arruzafa S.L.CordobaSpainRecruiting
Hospital Universitari General de CatalunyaSant Cugat del VallèsSpainRecruiting
Instituto Oftalmologico Gomez-Ulla S.L.Santiago De CompostelaSpainRecruiting
Centre Hospitalier Intercommunal CreteilCreteil CedexFranceRecruiting
Centre Hospitalier Universitaire de DijonDijonFranceRecruiting
Hospices Civils De LyonLyon Cedex 04FranceRecruiting
Fondation A. de RothschildParisFranceRecruiting
RetinaSaint-Cyr-Sur-LoireFranceRecruiting
-BristolUnited KingdomRecruiting
-LondonUnited KingdomRecruiting
-Newcastle upon TyneUnited KingdomRecruiting
-SouthamptonUnited KingdomRecruiting
Central Hospital Of Northern Pest Military HospitalBudapest VIHungaryRecruiting
Semmelweis UniversityBudapest VIIIHungaryRecruiting
Budapest Retina Associates Kft.Budapest XIIIHungaryRecruiting
University of DebrecenDebrecenHungaryRecruiting
Nozologen Kft.PécsHungaryRecruiting
Azienda Ospedaliero-Universitaria CareggiFlorenceItalyRecruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilanItalyRecruiting
Ospedale San Raffaele S.r.l.MilanItalyRecruiting
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In OftalmologiaRomeItalyRecruiting
-AmagasakiJapanRecruiting
-Bunkyo KuJapanRecruiting
-Chiyoda-kuJapanRecruiting
-KobeJapanRecruiting
OFTALMIKA Sp. z o.oBydgoszczPolandRecruiting
Centrum Medyczne Dietla 19 Sp. z o.o.CracowPolandRecruiting
Caminomed Sp. z o.o.Tarnowskie GóryPolandRecruiting
Emanuelli Research and Development Center, LLCAreciboPuerto RicoRecruiting
Arensia Clinics S.R.L.BucharestRomaniaRecruiting
Spitalul Clinic Judetean De Urgenta ClujCluj-NapocaRomaniaRecruiting
Retina Consultants TX Rsrch CtrBellaireUnited StatesRecruiting
Opthamalic Consultants of BostonBostonUnited StatesRecruiting
Advanced research, LLCBoynton BeachUnited StatesRecruiting
Advanced Research LLCDeerfield BeachUnited StatesRecruiting
Erie Retina Research LLCErieUnited StatesRecruiting
Retina Consultants of Houston PAHoustonUnited StatesRecruiting
Salehi Retina InstituteHuntington BeachUnited StatesRecruiting
Retina Consultants of TexasKatyUnited StatesRecruiting
Retina Associates New OrleansMetairieUnited StatesRecruiting
New York Eye and Ear Infirmary of Mount SinaiNew YorkUnited StatesRecruiting
Columbia University Medical CenterNew YorkUnited StatesRecruiting
Mid Atlantic RetinaPhiladelphiaUnited StatesRecruiting
Retinal Consultants Medical Group, Inc.SacramentoUnited StatesRecruiting
California Retina ConsultantsSanta BarbaraUnited StatesRecruiting
Retina Vitreous Associates of FloridaSt. PetersburgUnited StatesRecruiting
NJ RetinaToms RiverUnited StatesRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.