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 · NCT07441642
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 50+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 272
- US sites recruiting
- 15
- Study start
- March 9, 2026
- Record last updated
- October 13, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Being studied: FWY003; Placebo
Conditions: Geographic Atrophy Secondary to Age-related Macular Degeneration
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
- 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.
Exclusion Criteria
- A history of, or current evidence of, choroidal neovascularization (exudative MNV) in the study eye.
- 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 which in the opinion of the Reading Center could interfere with the assessment of study images.
Other protocol-defined inclusion/exclusion criteria may apply.
Recruiting US locations
Salehi Retina Institute
Huntington Beach, CA 92647
Site contact: Gillian Nguyen · +1 657 227 9496 · g.nguyen@retinasocal.com
Retinal Consultants Medical Group Inc
Sacramento, CA 95841
Site contact: Daniel Ortiz · +1 916 339 3655 · ortizd@retinalmd.com
California Retina Consultants
Santa Barbara, CA 93103
Site contact: Muskaan Kaur Bal · +1 805 963 1648 · muskaanb@californiaretina.com
Advanced Research LLC
Boynton Beach, FL 33437
Site contact: Alayka Reddy · areddy@advancedresearchfl.com
Advanced Research LLC
Deerfield Beach, FL 33064
Site contact: Quacian Dennis · +1 954 204 0052 · qdennis@advancedresearchfl.com
Retina Vitreous Associates of Florida
St. Petersburg, FL 33711
Site contact: Logan Wilson · +1 727 323 0077 · lwilson@rvaf.com
Opthamalic Consultants of Boston
Boston, MA 02114
Site contact: Haylie Carlon · +1 617 314 2636 · hcarlon@eyeboston.com
NJ Retina
Toms River, NJ 08755
Site contact: Andy Merino · +1 732 906 1887 · amerino@njretina.com
New York Eye and Ear Infirmary of Mount Sinai
New York, NY 10003
Site contact: Katy Tai · +1 212 979 4251 · ktai@nyee.edu
Columbia University Medical Center
New York, NY 10032
Site contact: Sokleab Em · +1 212 305 6361 · se2389@cumc.columbia.edu
Erie Retina Research LLC
Erie, PA 16505
Site contact: Jade Horn · jhorn@erieretinaresearch.com
Mid Atlantic Retina
Philadelphia, PA 19107
Site contact: Angelique Ortiz · +1 800 331 6634 · asortiz@midatlanticretina.com
Retina Consultants TX Rsrch Ctr
Bellaire, TX 77401
Site contact: MaryGrace Powers · +1 713 524 3434 · marygrace.powers@retinaconsultantstexas.com
Retina Consultants of Houston PA
Houston, TX 77030
Site contact: Erin Shelato · erin.shelato@retinaconsultantstexas.com
Retina Consultants of Texas
Katy, TX 77494
Site contact: Kymmia Majedi · kymmia.majedi@retinaconsultantstexas.com
Study contacts (from the official record)
- Novartis Pharmaceuticals · 1-888-669-6682 · novartis.email@novartis.com
- Novartis Pharmaceuticals · +41613241111