NCT07368959招募中3 期
ASTRA: A Phase 3 Multi-center, Randomized, Double-Masked, Prospective Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-3)
Aurion Biotech12 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年2月19日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 12
- 主要终点
- Percentage of participants who achieve a ≥ 15-letter improvement (3-line gain) from baseline in Best Corrected Visual Acuity (BCVA) at Month 6
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of single injection dose of AURN001 compared with placebo in adult participants with corneal edema secondary to corneal endothelial dysfunction.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Key Ocular Inclusion Criteria:
- •(All ocular criteria apply to the study eye unless noted otherwise)
- •Have corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty)
- •BCVA between 65 ETDRS letters (approximate 20/50 Snellen equivalent) and 5 ETDRS letters (approximate 20/800 Snellen equivalent)
- •Be pseudophakic with PCIOL
排除标准
- •(All ocular criteria apply to the study eye unless noted otherwise)
- •Have progressive corneal dystrophies or degenerations
- •Have visually significant corneal or other ocular pathologies
- •Other inclusion/exclusion criteria may apply.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will receive single dose of placebo control.
干预措施: Placebo (Other)
AURN001
Experimental
Participants will receive single dose of AURN001
干预措施: Combination Product: AURN001 + Y-27632 (Drug)
结局指标
主要结局
Percentage of participants who achieve a ≥ 15-letter improvement (3-line gain) from baseline in Best Corrected Visual Acuity (BCVA) at Month 6
时间窗: At Month 6
次要结局
- Change from baseline in non-contact Central Corneal Thickness (CCT) at Month 6(Baseline (Day 1) and At Month 6)
- Change from baseline in BCVA at Month 6(Baseline (Day 1) and At Month 6)
研究者
研究点 (12)
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