To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
This study is designed as a randomized, multi-center, double-masked, prospective study to characterize the dose response relationship, efficacy and safety of FWY003.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
272
Change of geographic atrophy (GA) lesion area in the study eye
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).
Time frame: From Baseline to Month 18
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
To assess the safety and tolerability of FWY003.
Time frame: From first dose (Day 1) to Month 19
Change in visual function measure by ETDRS (Regular Luminance) Best Corrected Visual Acuity (BCVA) in the study eye
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.
Time frame: Baseline through Month 18
Change in visual function measure by ETDRS Low Luminance Visual Acuity (LLVA) in the study eye
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.
Time frame: Baseline through Month 18
Change in visual function measure by Quantitative contrast sensitivity function (qCSF) under regular luminance in the study eye
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.
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Salehi Retina Institute
Huntington Beach, California, United States
RECRUITINGRetinal Consultants Medical Group Inc
Sacramento, California, United States
RECRUITINGCalifornia Retina Consultants
Santa Barbara, California, United States
RECRUITINGAdvanced Research LLC
Boynton Beach, Florida, United States
RECRUITINGAdvanced Research LLC
Deerfield Beach, Florida, United States
RECRUITINGRetina Vitreous Associates of Florida
St. Petersburg, Florida, United States
RECRUITINGOpthamalic Consultants of Boston
Boston, Massachusetts, United States
RECRUITINGNJ Retina
Toms River, New Jersey, United States
RECRUITINGNew York Eye and Ear Infirmary of Mount Sinai
New York, New York, United States
RECRUITINGColumbia University Medical Center
New York, New York, United States
RECRUITING...and 45 more locations
Time frame: Baseline through Month 18
Change in visual function measure by Low Contrast quantitative Visual Acuity (LCqVA) under regular luminance in the study eye
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.
Time frame: Baseline through Month 18
Change in visual function measure by LCqVA under low luminance in the study eye
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).
Time frame: Baseline through Month 18
Proportion of participants with ≥15 letters loss
To measure how many participants in a study lose 15 or more letters on a visual test
Time frame: Baseline through Month 18
Change in area of total and partial ellipsoid zone (EZ) attenuation in the macula in the study eye
To assess the effect of FWY003 on photoreceptor parameters in the study eye.
Time frame: Baseline through Month 18
Plasma concentrations of FWY003
To assess the pharmacokinetic profile of FWY003.
Time frame: Baseline through Month 18
Rate of change of GA lesion area (square-root transformed) in the study eye
To assess the rate of change in GA lesion area in the study eye.
Time frame: Baseline through Month 18
Change of GA lesion area (square-root transformed)
To assess the effect of FWY003 on GA lesion area.
Time frame: Baseline through Month 12