NCT07441642招募中2 期
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
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 272
- 试验地点
- 57
- 主要终点
- Change of geographic atrophy (GA) lesion area in the study eye
研究概览
简要总结
To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
详细描述
This study is designed as a randomized, multi-center, double-masked, prospective study to characterize the dose response relationship, efficacy and safety of FWY003.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Total GA area must be ≥2.5 and ≤17.5 mm2 (1 and 7 disk areas (DA), respectively)
- •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
- •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.
排除标准
- •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/exclusion criteria may apply.
研究组 & 干预措施
FWY003 dose level 3
Experimental
Participants will receive FWY003 dose level 3
干预措施: FWY003 (Drug)
Placebo
Placebo Comparator
Participants will receive placebo
干预措施: Placebo (Drug)
FWY003 dose level 1
Experimental
Participants will receive FWY003 dose level 1
干预措施: FWY003 (Drug)
FWY003 dose level 2
Experimental
Participants will receive FWY003 dose level 2
干预措施: FWY003 (Drug)
结局指标
主要结局
Change of geographic atrophy (GA) lesion area in the study eye
时间窗: 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).
Change of geographic atrophy (GA) lesion area
时间窗: From Baseline to Month 18
To evaluate the dose response relationship of FWY003 on GA lesion area in participants with GA secondary to age-related macular degeneration (AMD).
次要结局
- Rate of change of GA lesion area (square-root transformed) in the study eye(Baseline through Month 18)
- Change in visual function measure by ETDRS (Regular Luminance) Best Corrected Visual Acuity (BCVA) in the study eye(Baseline through Month 18)
- Change in visual function measure by ETDRS Low Luminance Visual Acuity (LLVA) in the study eye(Baseline through Month 18)
- Change in visual function measure by Quantitative contrast sensitivity function (qCSF) under regular luminance in the study eye(Baseline through Month 18)
- Change in visual function measure by Low Contrast quantitative Visual Acuity (LCqVA) under regular luminance in the study eye(Baseline through Month 18)
- Change in visual function measure by LCqVA under low luminance in the study eye(Baseline through Month 18)
- Change in area of total and partial ellipsoid zone (EZ) attenuation in the macula in the study eye(Baseline through Month 18)
- Number of participants with adverse events (AEs) and serious adverse events (SAEs)(From first dose (Day 1) to Month 19)
- Change in visual function measure by ETDRS (Regular Luminance) Best Corrected Visual Acuity (BCVA)(Baseline through Month 18)
- Change in visual function measure by ETDRS Low Luminance Visual Acuity (LLVA)(Baseline through Month 18)
- Change in visual function measure by Quantitative contrast sensitivity function (qCSF) under regular luminance(Baseline through Month 18)
- Change in visual function measure by Low Contrast quantitative Visual Acuity (LCqVA) under regular luminance(Baseline through Month 18)
- Change in visual function measure by LCqVA under low luminance(Baseline through Month 18)
- Proportion of participants with ≥15 letters loss(Baseline through Month 18)
- Change in area of total and partial ellipsoid zone (EZ) attenuation in the macula(Baseline through Month 18)
- Plasma concentrations of FWY003(Baseline through Month 18)
- Change of GA lesion area (square-root transformed)(Baseline through Month 12)
研究者
研究点 (57)
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