Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07441642

A Study to Investigate Efficacy and Safety of FWY003 Compared With Placebo in Participants 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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Geographic Atrophy Secondary to Age-related Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Albury, New South Wales, Australia

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

FWY003

Drug

FWY003 arm participants will receive a specific dose of FWY003

Placebo

Drug

Placebo arm participants will receive placebo

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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

  8. 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.

  9. Plasma concentrations of FWY003

    Time frame: Baseline through Month 18

    To assess the pharmacokinetic profile of FWY003.

  10. 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.

  11. Change of GA lesion area (square-root transformed)

    Time frame: Baseline through Month 12

    To assess the effect of FWY003 on GA lesion area.

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

1-888-669-6682

Novartis Pharmaceuticals

CONTACT

+41613241111

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 2, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.