FWY003 versus placebo for geographic atrophy from age-related macular degeneration

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

This study will test whether injections of FWY003 can slow the growth of geographic atrophy in people aged 50 and older with AMD.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 272 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Novartis (industry)
• Locations: 16 sites (Huntington Beach, California and 15 other locations)
• Trial ID: NCT07441642 on ClinicalTrials.gov

What this trial studies

This is a randomized, multi-center, double-masked, prospective Phase 2 trial comparing different doses of FWY003 to placebo in participants with geographic atrophy (GA) secondary to age-related macular degeneration. Participants are assigned to receive FWY003 or placebo and followed with standardized imaging and visual acuity testing to characterize dose-response, efficacy, and safety. Central reading of multimodal imaging is used to confirm eligibility and measure GA area changes over time. The trial excludes eyes with current or prior choroidal neovascularization and prior ocular gene or cell therapy to isolate effects on non-exudative GA.

Who should consider this trial

Good fit: Adults aged 50 or older with GA due to AMD in at least one eye, total GA area between 2.5 and 17.5 mm2, and ETDRS best-corrected visual acuity of at least 35 letters (≈20/200) in the study eye are ideal candidates.

Not a fit: People with current or prior choroidal neovascularization (exudative MNV), prior ocular cell or gene therapy, or macular atrophy from causes other than AMD are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, FWY003 could slow GA lesion growth and help preserve vision for a longer time in people with GA from AMD.

How similar studies have performed: Other complement-targeting therapies have shown reductions in GA growth in prior phase 2/3 trials, so there is precedent for this biological approach but FWY003 itself remains to be tested.

Eligibility 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.

  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.

Where this trial is running

Huntington Beach, California and 15 other locations

• Salehi Retina Institute — Huntington Beach, California, United States (RECRUITING)
• Retinal Consultants Medical Group Inc — Sacramento, California, United States (RECRUITING)
• Advanced Research LLC — Boynton Beach, Florida, United States (RECRUITING)
• Advanced Research LLC — Deerfield Beach, Florida, United States (RECRUITING)
• Retina Vitreous Associates of Florida — St. Petersburg, Florida, United States (RECRUITING)
• Opthamalic Consultants of Boston — Boston, Massachusetts, United States (RECRUITING)
• NJ Retina — Toms River, New Jersey, United States (RECRUITING)
• Erie Retina Research LLC — Erie, Pennsylvania, United States (RECRUITING)
• Retina Consultants TX Rsrch Ctr — Bellaire, Texas, United States (RECRUITING)
• Retina Consultants of Houston PA — Houston, Texas, United States (RECRUITING)
• Retina Consultants of Texas — Katy, Texas, United States (RECRUITING)
• Novartis Investigative Site — Albury, New South Wales, Australia (RECRUITING)
• Novartis Investigative Site — Parramatta, New South Wales, Australia (RECRUITING)
• Novartis Investigative Site — Strathfield, New South Wales, Australia (RECRUITING)
• Novartis Investigative Site — East Melbourne, Victoria, Australia (RECRUITING)
• Novartis Investigative Site — Ottawa, Ontario, Canada (RECRUITING)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions: Geographic Atrophy Secondary to Age-related Macular Degeneration, FWY003, safety, tolerability, geographical atrophy