Last Update: May 05, 2026
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
ClinicalTrials.gov Identifier:
Novartis Reference Number:CFWY003A12201
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). This study is designed as a randomized, multi-center, double-masked, prospective study to characterize the dose response relationship, efficacy and safety of FWY003.

Geographic Atrophy Secondary to Age-related Macular Degeneration
Phase2
Recruiting
272
Mar 09, 2026
Aug 22, 2029
All
50 Years - (Adult, Older Adult)

Interventions

Drug

FWY003

FWY003 arm participants will receive a specific dose of FWY003
Drug

Placebo

Placebo arm participants will receive placebo

Eligibility Criteria

Inclusion Criteria:

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.

1. Total GA area must be ≥2.5 and ≤17.5 mm2 (1 and 7 disk areas (DA), respectively)
2. 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
3. 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 Criteria:

* A history of, or current evidence of, choroidal neovascularization (exudative MNV) in either eye, as determined by the central reading center on multimodal imaging at screening.
* Previous cell or gene therapy in either eye.
* Macular atrophy in either eye due to a cause other than AMD, such as Stargardt disease, cone rod dystrophy, toxic maculopathies, etc.
* Intraocular surgery, including cataract and vitreoretinal surgery, in the study eye within 3 months prior to Baseline.
* 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 interfere with retinal imaging data quality.

Other protocol-defined inclusion/exclusion criteria may apply.

Novartis Investigative Site

Recruiting

East Melbourne,Victoria,3002,Australia

Novartis Investigative Site

Recruiting

Strathfield,New South Wales,2135,Australia

Novartis Investigative Site

Recruiting

Parramatta,New South Wales,2150,Australia

Novartis Investigative Site

Recruiting

Albury,New South Wales,2640,Australia

Novartis Investigative Site

Recruiting

Ottawa,Ontario,K2b 7e9,Canada

Retina Consultants of Houston PA

Recruiting

Houston,Texas,77030,United States

Erin Shelato
Charles C Wykoff

Salehi Retina Institute

Recruiting

Huntington Beach,California,92647,United States

Gillian Nguyen
Hani Salehi-Had

Retinal Consultants Medical Group Inc

Recruiting

Sacramento,California,95841,United States

Margaret Chang
Daniel Ortiz

Retina Consultants of Texas

Recruiting

Katy,Texas,77494,United States

Kymmia Majedi
Kenneth Fan

NJ Retina

Recruiting

Toms River,New Jersey,08755,United States

Howard Fine
Andy Merino

Retina Vitreous Associates of Florida

Recruiting

St. Petersburg,Florida,33711,United States

Logan Wilson
David Eichenbaum

Opthamalic Consultants of Boston

Recruiting

Boston,Massachusetts,02114,United States

Jeffrey S Heier
Hanna Raymond

Advanced Research LLC

Recruiting

Deerfield Beach,Florida,33064,United States

Shailesh Gupta
Isabella Villalonga

Advanced Research LLC

Recruiting

Boynton Beach,Florida,33437,United States

Drew Philip Bawcombe
Alayka Reddy

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Novartis Pharmaceuticals

Novartis Pharmaceuticals