NCT06630169进行中（未招募）2 期
APANECA: A Prospective, Parallel-arm, Multi-Surgeon Study of Cryopreserved AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (2024-E002-C)
Aurion Biotech1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年9月16日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- BCVA - 15-letter improvement (3-line gain)
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of cryopreserved AURN001 in patients with corneal edema secondary to 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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty)
- •BCVA no worse than 5 ETDRS letters (i.e., 1.6 LogMAR or approximate 20/800 Snellen equivalent).
排除标准
- •Have pre-operative corneal epithelial, sub-epithelial or stromal scarring or other opacity that is paracentral/central and visually significant, but not suspected to be secondary to corneal endothelial disease with the potential to improve from treatment in the study eye
- •Have history or presence of an ocular disease other than corneal endothelial dysfunction that could affect vision or safety assessments
研究组 & 干预措施
Arm 1
Other
Endothelial polishing zone 1 (low)
干预措施: Cryopreserved AURN001 (Combination Product)
Arm 2
Other
Endothelial polishing zone 2 (medium)
干预措施: Cryopreserved AURN001 (Combination Product)
Arm 3
Other
Endothelial polishing zone 3 (high)
干预措施: Cryopreserved AURN001 (Combination Product)
结局指标
主要结局
BCVA - 15-letter improvement (3-line gain)
时间窗: Month 6
Response, defined as a ≥15-letter improvement (3-line gain) from baseline in best-corrected visual acuity (BCVA)
次要结局
未报告次要终点
研究者
研究点 (1)
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