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NCT07441642PHASE2Recruiting

A Study to Investigate Efficacy and Safety of FWY003 Compared With Placebo in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

Novartis Pharmaceuticals

Start Date

3/9/2026

Completion Date

8/22/2029

Summary

To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Detailed Description

This study is designed as a randomized, multi-center, double-masked, prospective study to characterize the dose response relationship, efficacy and safety of FWY003.

Eligibility Criteria

Age Range: 50 years to No maximum

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.

Interventions

DRUG

FWY003

DRUG

Placebo

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Conditions

Geographic Atrophy Secondary to Age-related Macular Degeneration

Locations

Salehi Retina Institute

Huntington Beach, California 92647

United States

Retinal Consultants Medical Group Inc

Sacramento, California 95841

United States

California Retina Consultants

Santa Barbara, California 93103

United States

Advanced Research LLC

Boynton Beach, Florida 33437

United States

Advanced Research LLC

Deerfield Beach, Florida 33064

United States

Retina Vitreous Associates of Florida

St. Petersburg, Florida 33711

United States

Opthamalic Consultants of Boston

Boston, Massachusetts 02114

United States

NJ Retina

Toms River, New Jersey 08755

United States

New York Eye and Ear Infirmary of Mount Sinai

New York, New York 10003

United States

Columbia University Medical Center

New York, New York 10032

United States

Erie Retina Research LLC

Erie, Pennsylvania 16505

United States

Mid Atlantic Retina

Philadelphia, Pennsylvania 19107

United States

Retina Consultants TX Rsrch Ctr

Bellaire, Texas 77401

United States

Retina Consultants of Houston PA

Houston, Texas 77030

United States

Retina Consultants of Texas

Katy, Texas 77494

United States

Novartis Investigative Site

Albury, New South Wales 2640

Australia

Novartis Investigative Site

Parramatta, New South Wales 2150

Australia

Novartis Investigative Site

Strathfield, New South Wales 2135

Australia

Novartis Investigative Site

East Melbourne, Victoria 3002

Australia

Novartis Investigative Site

Sofia, 1618

Bulgaria

Novartis Investigative Site

London, Ontario N6A 4L8

Canada

Novartis Investigative Site

Ottawa, Ontario K2B 7E9

Canada

Novartis Investigative Site

Prague, 100 34

Czechia

Novartis Investigative Site

Prague, 128 08

Czechia

Novartis Investigative Site

Lyon, Rhone 69004

France

Novartis Investigative Site

Créteil, 94000

France

Novartis Investigative Site

Dijon, 21000

France

Novartis Investigative Site

Paris, 75940

France

Novartis Investigative Site

Bonn, 53105

Germany

Novartis Investigative Site

Ludwigshafen, 67063

Germany

Novartis Investigative Site

Münster, 48145

Germany

Novartis Investigative Site

Tübingen, 72076

Germany

Novartis Investigative Site

Pécs, Baranya 7621

Hungary

Novartis Investigative Site

Debrecen, Hajdu Bihar Megye 4032

Hungary

Novartis Investigative Site

Budapest, H-1083

Hungary

Novartis Investigative Site

Florence, FI 50134

Italy

Novartis Investigative Site

Milan, MI 20122

Italy

Novartis Investigative Site

Milan, MI 20132

Italy

Novartis Investigative Site

Roma, RM 00184

Italy

Novartis Investigative Site

Bunkyo Ku, Tokyo 113-8655

Japan

Novartis Investigative Site

Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-631

Poland

Novartis Investigative Site

Krakow, 31-070

Poland

Emanuelli Research and Development Center LLC

Arecibo, 00612

Puerto Rico

Novartis Investigative Site

Cluj-Napoca, Cluj 400006

Romania

Novartis Investigative Site

Bucharest, 011658

Romania

Novartis Investigative Site

Santiago Compostela, A Coruna 15706

Spain

Novartis Investigative Site

Sant Cugat Del V, Barcelona 08190

Spain

Novartis Investigative Site

Burjassot, Valencia 46100

Spain

Novartis Investigative Site

Córdoba, 14012

Spain

Novartis Investigative Site

Bristol, BS1 2LX

United Kingdom

Novartis Investigative Site

London, NW10 7NS

United Kingdom