NCT05309135已完成1 期
A Phase 1, Double-Masked, Randomized, Safety and Efficacy, Single Center Clinical Evaluation of Corneal Injection for Endothelial Dysfunction Using Human Corneal Endothelial Cell Therapy (HCEC-1) in Adult Subjects With Corneal Edema Secondary to Endothelial Dysfunction
Aurion Biotech1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2022年3月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Incidence and severity of Treatment Emergent Ocular Adverse Events (TEAEs)
研究概览
简要总结
The purpose of this study is to assess the safety of a fixed dose of human corneal endothelial cells when administered with varying concentrations of Rho kinase inhibitor (Y-27632) 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Within the treated groups, the sponsor, investigator, assessor, and subject will be masked to the assigned dose.
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
- •Must have given written informed consent (signed and dated by subject or legal guardian), and any authorizations required by local law and be able to comply with all study requirements
- •Clinical diagnosis of corneal edema secondary to endothelial dysfunction
- •Best Corrected Visual Acuity (BCVA) no worse than 20/800 ETDRS (1.6 LogMAR) or better than 20/63 (0.5 LogMAR) in the study eye
排除标准
- •Keratoconus or other conditions of corneal thinning/ectasia
- •Progressive stromal or anterior corneal dystrophies
- •Pre-operative corneal epithelial, sub-epithelial or stromal staining, 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 with HCEC-1
- •Prior ophthalmic surgery including cataract surgery except as noted above in Inclusion Criterion #4, corneal transplantation, glaucoma (MIGS, iridectomy, trabeculectomy, valve), or vitreo-retinal surgery, aphakia, anterior chamber-IOL or iris claw IOL, multifocal IOL.
- •Relative Afferent Pupillary Defect (RAPD) in the study eye
- •Uncontrolled glaucoma or an IOP greater than 24 mmHg that is not controlled with topical beta blockers alone at the time of the Screening Visit.
研究组 & 干预措施
Low dose Rho kinase inhibitor Y-27632
Active Comparator
Low dose Rho kinase inhibitor Y-27632
干预措施: HCEC-1 (Drug)
Mid dose Rho kinase inhibitor Y-27632
Active Comparator
Mid dose Rho kinase inhibitor Y-27632
干预措施: HCEC-1 (Drug)
High dose Rho kinase inhibitor Y-27632
Active Comparator
High dose Rho kinase inhibitor Y-27632
干预措施: HCEC-1 (Drug)
结局指标
主要结局
Incidence and severity of Treatment Emergent Ocular Adverse Events (TEAEs)
时间窗: 12 months
Incidence and severity of non-ocular TEAEs
时间窗: 12 months
次要结局
- Change from baseline in Best-Corrected Visual Acuity (BCVA) as measured by LogMAR score(12 months)
- Change from baseline in Central Corneal Thickness (CCT) as measured by pachymetry(12 months)
研究者
研究点 (1)
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