Recruiting

Phase 2

FWY003A Study to Investigate Efficacy and Safety of FWY003 Compared With Placebo in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07441642

Conditions

Geographic Atrophy Secondary to Age-related Macular Degeneration

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

FWY003

Placebo

Study Details

Brief summary:

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

Conditions

Geographic Atrophy Secondary to Age-related Macular Degeneration

Study ID

NCT07441642

Start date

Mar 9, 2026

Status verified date

Sep, 2026

Completion date

Aug 22, 2029

Anticipated

Primary completion date

Aug 21, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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 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.

Study Design

Enrollment

272 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: FWY003 dose level 1

Participants will receive FWY003 dose level 1

experimental: FWY003 dose level 2

Participants will receive FWY003 dose level 2

experimental: FWY003 dose level 3

Participants will receive FWY003 dose level 3

placebo comparator: Placebo

Participants will receive placebo

Interventions

FWY003

FWY003 arm participants will receive a specific dose of FWY003

Placebo

Placebo arm participants will receive placebo

Primary outcome measure

Change of geographic atrophy (GA) lesion area in the study eye [ Time Frame: From Baseline to Month 18 ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111

Locations

Salehi Retina Institute

Recruiting

Huntington Beach, California, United States, 92647

Contacts

Gillian Nguyen

+1 657 227 9496 g.nguyen@retinasocal.com

Principal Investigator:

Hani Salehi-Had

Retinal Consultants Medical Group Inc

Recruiting

Sacramento, California, United States, 95841

Contacts

Daniel Ortiz

+1 916 339 3655 ortizd@retinalmd.com

Principal Investigator:

Margaret Chang

California Retina Consultants

Recruiting

Santa Barbara, California, United States, 93103

Contacts

Muskaan Kaur Bal

+1 805 963 1648 muskaanb@californiaretina.com

Principal Investigator:

Dante Pieramici

Advanced Research LLC

Recruiting

Boynton Beach, Florida, United States, 33437

Contacts

Alayka Reddy

areddy@advancedresearchfl.com

Principal Investigator:

Drew Philip Bawcombe

Advanced Research LLC

Recruiting

Deerfield Beach, Florida, United States, 33064

Contacts

Quacian Dennis

+1 954 204 0052 qdennis@advancedresearchfl.com

Principal Investigator:

Shailesh Gupta

Retina Vitreous Associates of Florida

Recruiting

St. Petersburg, Florida, United States, 33711

Contacts

Logan Wilson

+1 727 323 0077 lwilson@rvaf.com

Principal Investigator:

David Eichenbaum

Opthamalic Consultants of Boston

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Haylie Carlon

+1 617 314 2636 hcarlon@eyeboston.com

Principal Investigator:

Jeffrey S Heier

NJ Retina

Recruiting

Toms River, New Jersey, United States, 08755

Contacts

Andy Merino

+1 732 906 1887 amerino@njretina.com

Principal Investigator:

Howard Fine

New York Eye and Ear Infirmary of Mount Sinai

Recruiting

New York, New York, United States, 10003

Contacts

Katy Tai

+1 212 979 4251 ktai@nyee.edu

Principal Investigator:

Richard Rosen

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Sokleab Em

+1 212 305 6361 se2389@cumc.columbia.edu

Principal Investigator:

Tongalp Tezel

Erie Retina Research LLC

Recruiting

Erie, Pennsylvania, United States, 16505

Contacts

Jade Horn

jhorn@erieretinaresearch.com

Principal Investigator:

David Almeida

Mid Atlantic Retina

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Angelique Ortiz

+1 800 331 6634 asortiz@midatlanticretina.com

Principal Investigator:

Carl Regillo

Retina Consultants TX Rsrch Ctr

Recruiting

Bellaire, Texas, United States, 77401

Contacts

MaryGrace Powers

+1 713 524 3434 marygrace.powers@retinaconsultantstexas.com

Principal Investigator:

David M Brown

Retina Consultants of Houston PA

Recruiting

Houston, Texas, United States, 77030

Contacts

Erin Shelato

erin.shelato@retinaconsultantstexas.com

Principal Investigator:

Charles C Wykoff

Retina Consultants of Texas

Recruiting

Katy, Texas, United States, 77494

Contacts

Kymmia Majedi

kymmia.majedi@retinaconsultantstexas.com

Principal Investigator:

Kenneth Fan

Novartis Investigative Site

Recruiting

London, Ontario, Canada, N6A 4L8

Novartis Investigative Site

Recruiting

Ottawa, Ontario, Canada, K2B 7E9

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

FWY003
safety
tolerability
geographical atrophy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-09-09.