NCT07441642 A Study to Investigate Efficacy and Safety of FWY003 Compared With Placebo in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
| NCT ID | NCT07441642 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Geographic Atrophy Secondary to Age-related Macular Degeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 272 participants |
| Start Date | 2026-03-09 |
| Primary Completion | 2029-08-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 272 participants in total. It began in 2026-03-09 with a primary completion date of 2029-08-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07441642 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Geographic Atrophy Secondary to Age-related Macular Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07441642 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07441642 currently recruiting?
Yes, NCT07441642 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT07441642 trial being conducted?
This trial is being conducted at Huntington Beach, United States, Sacramento, United States, Santa Barbara, United States, Boynton Beach, United States and 11 additional locations.
Who is sponsoring the NCT07441642 clinical trial?
NCT07441642 is sponsored by Novartis Pharmaceuticals. The trial plans to enroll 272 participants.