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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Geographic Atrophy Secondary to Age-related Macular Degeneration

In brief

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

Key facts

Study ID

NCT07441642

Run by

Novartis Pharmaceuticals

People needed

272

Starts

2026-03-09

Expected to finish

2029-08-22

Last updated by the study team

2026-07-09

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Retinal Consultants Medical Group Inc — Sacramento, California, United States (enrolling)
• California Retina Consultants — Santa Barbara, California, United States (enrolling)
• Advanced Research LLC — Boynton Beach, Florida, United States (enrolling)
• Advanced Research LLC — Deerfield Beach, Florida, United States (enrolling)
• Retina Vitreous Associates of Florida — St. Petersburg, Florida, United States (enrolling)
• Opthamalic Consultants of Boston — Boston, Massachusetts, United States (enrolling)
• NJ Retina — Toms River, New Jersey, United States (enrolling)
• New York Eye and Ear Infirmary of Mount Sinai — New York, New York, United States (enrolling)
• Columbia University Medical Center — New York, New York, United States (enrolling)
• Erie Retina Research LLC — Erie, Pennsylvania, United States (enrolling)
• Mid Atlantic Retina — Philadelphia, Pennsylvania, United States (enrolling)
• Retina Consultants TX Rsrch Ctr — Bellaire, Texas, United States (enrolling)
• Retina Consultants of Houston PA — Houston, Texas, United States (enrolling)
• Retina Consultants of Texas — Katy, Texas, United States (enrolling)
• Novartis Investigative Site — Albury, New South Wales, Australia (enrolling)
• Novartis Investigative Site — Parramatta, New South Wales, Australia (enrolling)
• Novartis Investigative Site — Strathfield, New South Wales, Australia (enrolling)
• Novartis Investigative Site — East Melbourne, Victoria, Australia (enrolling)
• Novartis Investigative Site — Sofia, Bulgaria (enrolling)
• Novartis Investigative Site — London, Ontario, Canada (enrolling)
• Novartis Investigative Site — Ottawa, Ontario, Canada (enrolling)
• Novartis Investigative Site — Prague, Czechia (enrolling)
• Novartis Investigative Site — Prague, Czechia (enrolling)
• Novartis Investigative Site — Lyon, Rhone, France (enrolling)
• Salehi Retina Institute — Huntington Beach, California, United States (enrolling)

Full record on ClinicalTrials.gov

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