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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

Where it's running

• Salehi Retina Institute
  Huntington Beach, California, United States Recruiting
• Retinal Consultants Medical Group Inc
  Sacramento, California, United States Recruiting
• California Retina Consultants
  Santa Barbara, 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

+15 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• ADX-038 for geographic atrophy due to age-related macular degeneration

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.