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Clinical Trials in Germany / NCT07441642
Recruiting Phase 2

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

NCT07441642 · tracked via the Priya Life Science Germany tracker
Phase
Phase 2
Started
2026-03-09
Last updated
2026-09-09

Condition(s) studied

Geographic Atrophy Secondary to Age-related Macular Degeneration

Investigational drug(s) / intervention(s)

FWY003Placebo

FWY003: FWY003 arm participants will receive a specific dose of FWY003

Placebo: Placebo arm participants will receive placebo

Study summary

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

Eligibility

Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (55)

FacilityCityRegionStatus
Salehi Retina Institute Huntington Beach California Recruiting
Retinal Consultants Medical Group Inc Sacramento California Recruiting
California Retina Consultants Santa Barbara California Recruiting
Advanced Research LLC Boynton Beach Florida Recruiting
Advanced Research LLC Deerfield Beach Florida Recruiting
Retina Vitreous Associates of Florida St. Petersburg Florida Recruiting
Opthamalic Consultants of Boston Boston Massachusetts Recruiting
NJ Retina Toms River New Jersey Recruiting
New York Eye and Ear Infirmary of Mount Sinai New York New York Recruiting
Columbia University Medical Center New York New York Recruiting
Erie Retina Research LLC Erie Pennsylvania Recruiting
Mid Atlantic Retina Philadelphia Pennsylvania Recruiting
Retina Consultants TX Rsrch Ctr Bellaire Texas Recruiting
Retina Consultants of Houston PA Houston Texas Recruiting
Retina Consultants of Texas Katy Texas Recruiting
Novartis Investigative Site Albury New South Wales Recruiting
Novartis Investigative Site Parramatta New South Wales Recruiting
Novartis Investigative Site Strathfield New South Wales Recruiting
Novartis Investigative Site East Melbourne Victoria Recruiting
Novartis Investigative Site Sofia Bulgaria Recruiting
Novartis Investigative Site London Ontario Recruiting
Novartis Investigative Site Ottawa Ontario Recruiting
Novartis Investigative Site Barranquilla Atlántico Recruiting
Novartis Investigative Site Prague Czechia Recruiting
Novartis Investigative Site Prague Czechia Recruiting
Novartis Investigative Site Lyon Rhone Recruiting
Novartis Investigative Site Créteil France Recruiting
Novartis Investigative Site Dijon France Recruiting
Novartis Investigative Site Paris France Recruiting
Novartis Investigative Site Ludwigshafen Germany Recruiting
Novartis Investigative Site Bonn Germany Recruiting
Novartis Investigative Site Münster Germany Recruiting
Novartis Investigative Site Tübingen Germany Recruiting
Novartis Investigative Site Pécs Baranya Recruiting
Novartis Investigative Site Debrecen Hajdu Bihar Megye Recruiting
Novartis Investigative Site Budapest Hungary Recruiting
Novartis Investigative Site Florence FI Recruiting
Novartis Investigative Site Milan MI Recruiting
Novartis Investigative Site Milan MI Recruiting
Novartis Investigative Site Roma RM Recruiting

+ 15 more sites — see the full list on the official registry below.

More Novartis Pharmaceuticals trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07441642 on ClinicalTrials.gov ↗ ← All trials in Germany