FWY003A12201: FWY003 in patients with geographic atrophy
Research type
Research Study
Full title
A randomized, double masked, placebo-controlled, multicenter, dose-range finding study to assess the efficacy and safety of FWY003 in participants with geographic atrophy secondary to age-related macular degeneration.
IRAS ID
1011314
Contact name
Fiona Morris
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Limited
Clinicaltrials.gov Identifier
NCT 07441642
Research summary
The purpose of this study is to learn more about the effects and safety of FWY003 in people with geographic atrophy (GA) due to age-related macular degeneration (AMD). GA is a leading cause of vision loss in older adults and causes gradual and irreversible damage to the central part of the retina. This can lead to significant loss of vision, affecting independence and quality of life. There are currently no licenced treatments for GA in the United Kingdom. FWY003 is a medication that could potentially provide a treatment option for patients with GA living in the UK.
The researchers think FWY003 may reduce or stop enlargement of the GA lesions and possibly slow loss of vision caused by GA. The study will compare different doses of FWY003 to a placebo (a pill with no active drug).
Participants will be randomly assigned to receive either FWY003 or a placebo, taken for 18 months. The total study duration is up to 22 months, including screening and follow-up periods and participants will need to attend study site up to 18 times. Study assessments will include the collection of blood and urine samples, physical exam and vital signs, eye exams and imaging of the back of the eye, ECG (electrocardiogram - recordings of heart electrical activity), and completion of questionnaires.
About 272 participants in approximately 19 countries will be involved in the trial. Eligible participants will be adults aged 50 or older with GA due to AMD in at least one eye. Participants must meet specific vision and health criteria (assessed by study staff).REC name
London - Harrow Research Ethics Committee
REC reference
26/LO/0224
Date of REC Opinion
20 Apr 2026
REC opinion
Further Information Favourable Opinion