RECRUITINGPhase 2INTERVENTIONAL
A Study to Investigate Efficacy and Safety of FWY003 Compared With Placebo in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
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
About This Trial
To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Who May Be Eligible (Plain English)
Who May Qualify:
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.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
FWY003
FWY003 arm participants will receive a specific dose of FWY003
DRUG
Placebo
Placebo arm participants will receive placebo
Locations (7)
Salehi Retina Institute
Huntington Beach, California, United States
Advanced Research LLC
Boynton Beach, Florida, United States
Advanced Research LLC
Deerfield Beach, Florida, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States
Opthamalic Consultants of Boston
Boston, Massachusetts, United States
Novartis Investigative Site
Albury, New South Wales, Australia
Novartis Investigative Site
Parramatta, New South Wales, Australia