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

Conditions

Geographic atrophy secondary to age-related macular degeneration

Brief summary

Change of GA lesion area from Baseline to Month 18

Detailed description

Incidence and severity of ocular and non-ocular AEs, and systemic safety measures including physical examinations, vital signs, ECG and laboratory tests., Change in visual function in the study eye from Baseline through Month 18 as measured by: • Early treatment diabetic retinopathy study (ETDRS) (Regular Luminance) Best Corrected Visual Acuity (BCVA) • ETDRS Low Luminance Visual Acuity (LLVA) • Quantitative contrast sensitivity function (qCSF) under regular luminance • Low Contrast quantitative Visual Acuity (LCqVA) under regular luminance • LCqVA under low luminance • Proportion of participants with ≥15 letters loss from baseline, Change in area of total and partial ellipsoid zone (EZ) attenuation in the macula from Baseline through Month 18, Rate of change of GA lesion area (square-root transformed) in the study eye from Baseline through Month 18, Change of GA lesion area (square-root transformed) from Baseline through Month 00.

Related papers

No related papers found yet.

Interventions

DRUGFWY003

DRUGPlacebo to FWY003

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change of GA lesion area from Baseline to Month 18	—

Secondary

Measure	Time frame
Incidence and severity of ocular and non-ocular AEs, and systemic safety measures including physical examinations, vital signs, ECG and laboratory tests., Change in visual function in the study eye from Baseline through Month 18 as measured by: • Early treatment diabetic retinopathy study (ETDRS) (Regular Luminance) Best Corrected Visual Acuity (BCVA) • ETDRS Low Luminance Visual Acuity (LLVA) • Quantitative contrast sensitivity function (qCSF) under regular luminance • Low Contrast quantitative Visual Acuity (LCqVA) under regular luminance • LCqVA under low luminance • Proportion of participants with ≥15 letters loss from baseline, Change in area of total and partial ellipsoid zone (EZ) attenuation in the macula from Baseline through Month 18, Rate of change of GA lesion area (square-root transformed) in the study eye from Baseline through Month 18, Change of GA lesion area (square-root transformed) from Baseline through Month 00.	—

Measure

Time frame

Incidence and severity of ocular and non-ocular AEs, and systemic safety measures including physical examinations, vital signs, ECG and laboratory tests., Change in visual function in the study eye from Baseline through Month 18 as measured by: • Early treatment diabetic retinopathy study (ETDRS) (Regular Luminance) Best Corrected Visual Acuity (BCVA) • ETDRS Low Luminance Visual Acuity (LLVA) • Quantitative contrast sensitivity function (qCSF) under regular luminance • Low Contrast quantitative Visual Acuity (LCqVA) under regular luminance • LCqVA under low luminance • Proportion of participants with ≥15 letters loss from baseline, Change in area of total and partial ellipsoid zone (EZ) attenuation in the macula from Baseline through Month 18, Rate of change of GA lesion area (square-root transformed) in the study eye from Baseline through Month 18, Change of GA lesion area (square-root transformed) from Baseline through Month 00.

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Outcome results

None listed