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

NCT07441642 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CFWY003A12201
• Study Type: interventional
• Target: 272
• Locations: 12 countries
• Sites: 28

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

Keywords

FWY003; safety; tolerability; geographical atrophy

Outcome Measures

Primary Outcomes (1)

• Change of geographic atrophy (GA) lesion area

  To evaluate the dose response relationship of FWY003 on GA lesion area in participants with GA secondary to age-related macular degeneration (AMD).

  From Baseline to Month 18

Secondary Outcomes (11)

• Number of participants with adverse events (AEs) and serious adverse events (SAEs)

  From first dose (Day 1) to Month 19

• Change in visual function measure by ETDRS (Regular Luminance) Best Corrected Visual Acuity (BCVA)

  Baseline through Month 18

• Change in visual function measure by ETDRS Low Luminance Visual Acuity (LLVA)

  Baseline through Month 18

• Change in visual function measure by Quantitative contrast sensitivity function (qCSF) under regular luminance

  Baseline through Month 18

• Change in visual function measure by Low Contrast quantitative Visual Acuity (LCqVA) under regular luminance

  Baseline through Month 18

Study Arms (4)

FWY003 dose level 1

EXPERIMENTAL

Participants will receive FWY003 dose level 1

Drug: FWY003

FWY003 dose level 2

EXPERIMENTAL

Participants will receive FWY003 dose level 2

Drug: FWY003

FWY003 dose level 3

EXPERIMENTAL

Participants will receive FWY003 dose level 3

Drug: FWY003

Placebo

PLACEBO COMPARATOR

Participants will receive placebo

Drug: Placebo

Interventions

FWY003 DRUG

FWY003 arm participants will receive a specific dose of FWY003

FWY003 dose level 1; FWY003 dose level 2; FWY003 dose level 3

Placebo DRUG

Placebo arm participants will receive placebo

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (28)

Salehi Retina Institute

Huntington Beach, California, 92647, United States

RECRUITING

Retinal Consultants Medical Group Inc

Sacramento, California, 95841, United States

RECRUITING

California Retina Consultants

Santa Barbara, California, 93103, United States

RECRUITING

Advanced Research LLC

Boynton Beach, Florida, 33437, United States

RECRUITING

Advanced Research LLC

Deerfield Beach, Florida, 33064, United States

RECRUITING

Retina Vitreous Associates of Florida

St. Petersburg, Florida, 33711, United States

RECRUITING

Opthamalic Consultants of Boston

Boston, Massachusetts, 02114, United States

RECRUITING

NJ Retina

Toms River, New Jersey, 08755, United States

RECRUITING

Erie Retina Research LLC

Erie, Pennsylvania, 16505, United States

RECRUITING

Retina Consultants TX Rsrch Ctr

Bellaire, Texas, 77401, United States

RECRUITING

Retina Consultants of Houston PA

Houston, Texas, 77030, United States

RECRUITING

Retina Consultants of Texas

Katy, Texas, 77494, United States

RECRUITING

Novartis Investigative Site

Albury, New South Wales, 2640, Australia

RECRUITING

Novartis Investigative Site

Parramatta, New South Wales, 2150, Australia

RECRUITING

Novartis Investigative Site

Strathfield, New South Wales, 2135, Australia

RECRUITING

Novartis Investigative Site

East Melbourne, Victoria, 3002, Australia

RECRUITING

Novartis Investigative Site

Sofia, 1618, Bulgaria

RECRUITING

Novartis Investigative Site

Ottawa, Ontario, K2B 7E9, Canada

RECRUITING

Novartis Investigative Site

Prague, 128 08, Czechia

RECRUITING

Novartis Investigative Site

Créteil, 94000, France

RECRUITING

Novartis Investigative Site

Bonn, 53105, Germany

RECRUITING

Novartis Investigative Site

Pécs, Baranya, 7621, Hungary

RECRUITING

Novartis Investigative Site

Milan, MI, 20132, Italy

RECRUITING

Novartis Investigative Site

Roma, RM, 00184, Italy

RECRUITING

Novartis Investigative Site

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85 631, Poland

RECRUITING

Novartis Investigative Site

Krakow, 31-070, Poland

RECRUITING

Novartis Investigative Site

Bucharest, 011658, Romania

RECRUITING

Novartis Investigative Site

Burjassot, Valencia, 46100, Spain

RECRUITING

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

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

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 2, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): August 21, 2029
• Study Completion (Estimated): August 22, 2029
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

CZ (1); FR (1); CA (1); AU (4); US (12); PL (2); HU (1); RO (1); BU (1); IT (2); ES (1); DE (1)