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

May 29, 2026 updated by: Novartis Pharmaceuticals

A Randomized, Double Masked, Placebo-controlled, Multicenter, Dose-range Finding Study to Assess the Efficacy and Safety of FWY003 in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is designed as a randomized, multi-center, double-masked, prospective study to characterize the dose response relationship, efficacy and safety of FWY003.

Study Type

Interventional

Enrollment (Estimated)

272

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Australia
    • New South Wales
      • Albury, New South Wales, Australia, 2640
        • Recruiting
        • Novartis Investigative Site
      • Parramatta, New South Wales, Australia, 2150
        • Recruiting
        • Novartis Investigative Site
      • Strathfield, New South Wales, Australia, 2135
        • Recruiting
        • Novartis Investigative Site
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Recruiting
        • Novartis Investigative Site
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K2B 7E9
        • Recruiting
        • Novartis Investigative Site
  • Czechia
      • Prague, Czechia, 128 08
        • Recruiting
        • Novartis Investigative Site
  • France
      • Créteil, France, 94000
        • Recruiting
        • Novartis Investigative Site
  • Hungary
    • Baranya
      • Pécs, Baranya, Hungary, 7621
        • Recruiting
        • Novartis Investigative Site
  • Poland
      • Krakow, Poland, 31-070
        • Recruiting
        • Novartis Investigative Site
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85 631
        • Recruiting
        • Novartis Investigative Site
  • United States
    • California
      • Huntington Beach, California, United States, 92647
        • Recruiting
        • Salehi Retina Institute
        • Principal Investigator:
          • Hani Salehi-Had
        • Contact:
      • Sacramento, California, United States, 95841
        • Recruiting
        • Retinal Consultants Medical Group Inc
        • Principal Investigator:
          • Margaret Chang
        • Contact:
      • Santa Barbara, California, United States, 93103
        • Recruiting
        • California Retina Consultants
        • Principal Investigator:
          • Dante Pieramici
        • Contact:
    • Florida
      • Boynton Beach, Florida, United States, 33437
      • Deerfield Beach, Florida, United States, 33064
        • Recruiting
        • Advanced Research LLC
        • Contact:
        • Principal Investigator:
          • Shailesh Gupta.
      • St. Petersburg, Florida, United States, 33711
        • Recruiting
        • Retina Vitreous Associates of Florida
        • Principal Investigator:
          • David Eichenbaum
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Opthamalic Consultants of Boston
        • Principal Investigator:
          • Jeffrey S Heier
        • Contact:
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • NJ Retina
        • Contact:
        • Principal Investigator:
          • Howard Fine
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16505
    • Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo
Drug: Placebo
Placebo arm participants will receive placebo
Experimental: FWY003 dose level 1
Participants will receive FWY003 dose level 1
Drug: FWY003
FWY003 arm participants will receive a specific dose of FWY003
Experimental: FWY003 dose level 2
Participants will receive FWY003 dose level 2
Drug: FWY003
FWY003 arm participants will receive a specific dose of FWY003
Experimental: FWY003 dose level 3
Participants will receive FWY003 dose level 3
Drug: FWY003
FWY003 arm participants will receive a specific dose of FWY003

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of geographic atrophy (GA) lesion area
Time Frame: From Baseline to Month 18
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time Frame: From first dose (Day 1) to Month 19
To assess the safety and tolerability of FWY003.
From first dose (Day 1) to Month 19
Change in visual function measure by ETDRS (Regular Luminance) Best Corrected Visual Acuity (BCVA)
Time Frame: Baseline through Month 18
To assess the change in visual function over time by measuring Best Corrected Visual Acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart under normal lighting conditions. BCVA is the sharpest vision a person can achieve with optimal correction, such as glasses or contact lenses. The ETDRS eye chart is the standardized chart used in clinical trials.
Baseline through Month 18
Change in visual function measure by ETDRS Low Luminance Visual Acuity (LLVA)
Time Frame: Baseline through Month 18
To assess the change in visual function using Early Treatment Diabetic Retinopathy Study (ETDRS) Low Luminance Visual Acuity (LLVA) vision test. This test measures how well a person can see under low-light conditions. It is performed using the standard ETDRS eye chart.
Baseline through Month 18
Change in visual function measure by Quantitative contrast sensitivity function (qCSF) under regular luminance
Time Frame: Baseline through Month 18
To assess the change in visual function by using a test called the quantitative Contrast Sensitivity Function (qCSF). qCSF checks how faint a pattern a person can see, and how that changes for large vs. small details.
Baseline through Month 18
Change in visual function measure by Low Contrast quantitative Visual Acuity (LCqVA) under regular luminance
Time Frame: Baseline through Month 18
To assess the change in visual function using a test called Low Contrast quantitative Visual Acuity (LCqVA). LCqVA is visual acuity test where letters on the chart are printed with reduced contrast. The test is performed in normal lighting conditions.
Baseline through Month 18
Change in visual function measure by LCqVA under low luminance
Time Frame: Baseline through Month 18
To assess the change in visual function in dim-light conditions using a test called Low Contrast quantitative Visual Acuity (LCqVA). This test measures how well a person can read low-contrast letters. The test is performed with reduced luminance (making the environment darker).
Baseline through Month 18
Proportion of participants with ≥15 letters loss
Time Frame: Baseline through Month 18
To measure how many participants in a study lose 15 or more letters on a visual test
Baseline through Month 18
Change in area of total and partial ellipsoid zone (EZ) attenuation in the macula
Time Frame: Baseline through Month 18
To assess the effect of FWY003 on photoreceptor parameters.
Baseline through Month 18
Plasma concentrations of FWY003
Time Frame: Baseline through Month 18
To assess the pharmacokinetic profile of FWY003.
Baseline through Month 18
Rate of change of GA lesion area (square-root transformed) in the study eye
Time Frame: Baseline through Month 18
To assess the rate of change in GA lesion area.
Baseline through Month 18
Change of GA lesion area (square-root transformed)
Time Frame: Baseline through Month 12
To assess the effect of FWY003 on GA lesion area.
Baseline through Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2026

Primary Completion (Estimated)

August 21, 2029

Study Completion (Estimated)

August 22, 2029

Study Registration Dates

First Submitted

February 24, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CFWY003A12201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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