NCT05949593进行中（未招募）3 期
PHase 3, Multicenter, RandOmized, Double-masked, PlacEbo-CoNtrolled Study of TInlarebant to EXplore Safety and Efficacy in the Treatment of Geographic Atrophy (the PHOENIX Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 429
- 试验地点
- 49
- 主要终点
- To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size
研究概览
简要总结
This Phase 3, multicenter, double-masked, parallel-group, placebo-controlled, randomized, fixed-dose clinical study is designed to evaluate the efficacy and safety of tinlarebant (LBS-008) in subjects diagnosed with GA.
详细描述
Subjects will be randomized in a 2:1 ratio to receive either tinlarebant or placebo. The study treatment will be administered orally once daily from baseline (Day 1) through the final day of Month 24.
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)
盲法说明
Eligible subjects will be randomly assigned to begin treatment in 2:1 ratio to receive the study drug (either Tinlarebant 5 mg or matching placebo)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have a confirmed diagnosis of GA with atrophic lesions in 1 or both eyes.
- •Minimum BCVA is required in the study eye
排除标准
- •The presence of diabetic macular edema or macular disease in either eye.
- •Diabetic retinopathy more advanced than mild nonproliferative diabetic retinopathy, or any other retinal vascular disease in either eye.
- •Uncontrolled diagnosed glaucoma in the study eye
研究组 & 干预措施
LBS-008, Tinlarebant
Experimental
干预措施: Tinlarebant (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size
时间窗: From baseline to Month 24]
次要结局
- To measure the change in best-corrected visual acuity (BCVA) as assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale(From baseline to Month 24)
- To measure changes in the area and size of the inner/outer segment junction of photoreceptors by spectral domain optical coherence tomography (SD-OCT)(From baseline to Month 24)
研究者
研究点 (49)
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