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

RecruitingPhase 2

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

Who can join

Ages 50 and older · All sexes

Full 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 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.

About the study

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

What is being tested

Sponsor: Novartis Pharmaceuticals · Participants: 272 · Started: Mar 9, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07441642

Locations in the U.S.

CaliforniaSalehi Retina Institute, Huntington Beach
Retinal Consultants Medical Group Inc, Sacramento
California Retina Consultants, Santa Barbara
FloridaAdvanced Research LLC, Boynton Beach
Advanced Research LLC, Deerfield Beach
Retina Vitreous Associates of Florida, St. Petersburg
MassachusettsOpthamalic Consultants of Boston, Boston
New JerseyNJ Retina, Toms River
New YorkColumbia University Medical Center, New York
New York Eye and Ear Infirmary of Mount Sinai, New York
PennsylvaniaErie Retina Research LLC, Erie
Mid Atlantic Retina, Philadelphia
TexasRetina Consultants TX Rsrch Ctr, Bellaire
Retina Consultants of Houston PA, Houston
Retina Consultants of Texas, Katy

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.