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

What this study is about

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

Who can join (things the study team will check)

✅ You may be able to join if…

• 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 be able to join 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 this trial is running

• Salehi Retina Institute, Huntington Beach, California, United States
• Retinal Consultants Medical Group Inc, Sacramento, California, United States
• California Retina Consultants, Santa Barbara, California, United States
• Advanced Research LLC, Boynton Beach, Florida, United States
• Advanced Research LLC, Deerfield Beach, Florida, United States
• Retina Vitreous Associates of Florida, St. Petersburg, Florida, United States
• Opthamalic Consultants of Boston, Boston, Massachusetts, United States
• NJ Retina, Toms River, New Jersey, United States
• New York Eye and Ear Infirmary of Mount Sinai, New York, New York, United States
• Columbia University Medical Center, New York, New York, United States
• Erie Retina Research LLC, Erie, Pennsylvania, United States
• Mid Atlantic Retina, Philadelphia, Pennsylvania, United States

+ 39 more sites.

Who to contact

Novartis Pharmaceuticals · 1-888-669-6682 · novartis.email@novartis.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07441642.