A Study to Investigate Efficacy and Safety of FWY003 Compared With Placebo in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
Purpose
To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Condition
- Geographic Atrophy Secondary to Age-related Macular Degeneration
Eligibility
- Eligible Ages
- Over 50 Years
- Eligible Sex
- All
- Accepts 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 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental FWY003 dose level 1 |
Participants will receive FWY003 dose level 1 |
|
|
Experimental FWY003 dose level 2 |
Participants will receive FWY003 dose level 2 |
|
|
Experimental FWY003 dose level 3 |
Participants will receive FWY003 dose level 3 |
|
|
Placebo Comparator Placebo |
Participants will receive placebo |
|
Recruiting Locations
Huntington Beach, California 92647
Sacramento, California 95841
Santa Barbara, California 93103
Boynton Beach, Florida 33437
Deerfield Beach, Florida 33064
St. Petersburg, Florida 33711
Boston, Massachusetts 02114
New York, New York 10003
New York, New York 10032
Bellaire, Texas 77401
Houston, Texas 77030
Katy, Texas 77494
Arecibo, Puerto Rico 00612
More Details
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals
Detailed Description
This study is designed as a randomized, multi-center, double-masked, prospective study to characterize the dose response relationship, efficacy and safety of FWY003.