Geographic Atrophy Secondary to Age-related Macular Degeneration
Conditions
Keywords
FWY003, safety, tolerability, geographical atrophy
Brief summary
To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
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.
Interventions
DRUGFWY003
FWY003 arm participants will receive a specific dose of FWY003
DRUGPlacebo
Placebo arm participants will receive placebo
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of geographic atrophy (GA) lesion area in the study eye | From Baseline to Month 18 | To evaluate the dose response relationship of FWY003 on GA lesion area in the study eye in participants with GA secondary to age-related macular degeneration (AMD). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events (AEs) and serious adverse events (SAEs) | From first dose (Day 1) to Month 19 | To assess the safety and tolerability of FWY003. |
| Change in visual function measure by ETDRS (Regular Luminance) Best Corrected Visual Acuity (BCVA) in the study eye | Baseline through Month 18 | To assess the change in visual function over time by measuring Best Corrected Visual Acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart under normal lighting conditions. BCVA is the sharpest vision a person can achieve with optimal correction, such as glasses or contact lenses. The ETDRS eye chart is the standardized chart used in clinical trials. |
| Change in visual function measure by ETDRS Low Luminance Visual Acuity (LLVA) in the study eye | Baseline through Month 18 | To assess the change in visual function using Early Treatment Diabetic Retinopathy Study (ETDRS) Low Luminance Visual Acuity (LLVA) vision test. This test measures how well a person can see under low-light conditions. It is performed using the standard ETDRS eye chart. |
| Change in visual function measure by Low Contrast quantitative Visual Acuity (LCqVA) under regular luminance in the study eye | Baseline through Month 18 | To assess the change in visual function using a test called Low Contrast quantitative Visual Acuity (LCqVA). LCqVA is visual acuity test where letters on the chart are printed with reduced contrast. The test is performed in normal lighting conditions. |
| Change in visual function measure by LCqVA under low luminance in the study eye | Baseline through Month 18 | To assess the change in visual function in dim-light conditions using a test called Low Contrast quantitative Visual Acuity (LCqVA). This test measures how well a person can read low-contrast letters. The test is performed with reduced luminance (making the environment darker). |
| Proportion of participants with ≥15 letters loss | Baseline through Month 18 | To measure how many participants in a study lose 15 or more letters on a visual test |
| Change in area of total and partial ellipsoid zone (EZ) attenuation in the macula in the study eye | Baseline through Month 18 | To assess the effect of FWY003 on photoreceptor parameters in the study eye. |
| Plasma concentrations of FWY003 | Baseline through Month 18 | To assess the pharmacokinetic profile of FWY003. |
| Rate of change of GA lesion area (square-root transformed) in the study eye | Baseline through Month 18 | To assess the rate of change in GA lesion area in the study eye. |
| Change in visual function measure by Quantitative contrast sensitivity function (qCSF) under regular luminance in the study eye | Baseline through Month 18 | To assess the change in visual function by using a test called the quantitative Contrast Sensitivity Function (qCSF). qCSF checks how faint a pattern a person can see, and how that changes for large vs. small details. |
| Change of GA lesion area (square-root transformed) | Baseline through Month 12 | To assess the effect of FWY003 on GA lesion area. |
Countries
Australia, Bulgaria, Canada, Colombia, Czechia, France, Germany, Hungary, Italy, Japan, Poland, Puerto Rico, Romania, Spain, United Kingdom, United States
Contacts
CONTACTNovartis Pharmaceuticals
Outcome results
None listed