NCT05587205招募中1 期
Phase 1, Randomized, Masked, Sham-Controlled Study to Assess the Safety and Tolerability of EO2002 in Subjects Undergoing Cataract Surgery
Asociación para Evitar la Ceguera en México1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年8月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Safety and Tolerability of EO2002
研究概览
简要总结
The goal of this clinical study is to assess the safety of intracameral injection of EO2002 in subjects post-cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
2 arms are masked as indicated and 2 arms are open label
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
- •Age ≥ 18 years.
- •Subject has uncomplicated history of cataract that has progressed to a level requiring standard cataract extraction with intraocular lens implant surgery.
- •Decreased endothelial cell count
排除标准
- •All ocular criteria apply to study eye unless otherwise noted.
- •Other corneal disease
- •Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.
- •Descemet membrane detachment.
- •History of uveitis or other ocular inflammatory disease.
- •History of incisional glaucoma surgery
- •Prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty.
- •History of ocular neoplasm.
- •ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20/200).
- •Female who is pregnant, nursing, or planning to become pregnant, or who is of childbearing potential and not using a reliable means of contraception during the study.
- •Subject is currently participating in or has participated within the last 3 months in any other clinical trial of an investigational drug by ocular or systemic administration.
- •Any concomitant medical or psychological condition that could interfere with study participation or is otherwise not suitable for entry into the study in the opinion of the investigator.
研究组 & 干预措施
Treatment at time of surgery
Experimental
EO2002 intracameral injection
干预措施: EO2002 (Biological)
Treatment post surgery
Experimental
EO2002 intracameral injection
干预措施: EO2002 (Biological)
Treatment at time of or post surgery
Active Comparator
EO2002 intracameral injection
干预措施: EO2002 (Biological)
Sham injection at time of or post surgery
Sham Comparator
Sham injection
干预措施: Sham injection (Other)
结局指标
主要结局
Safety and Tolerability of EO2002
时间窗: 26 weeks
Incidence of Treatment-Emergent Adverse Events
次要结局
- Endothelial Cell Density(26 weeks)
研究者
研究点 (1)
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