NCT04552730已完成不适用
Observational Study of Cenegermin-bkbj in the Treatment of Limbal Stem Cell Deficiency Associated With Neurotrophic Keratopathy
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Size of abnormal epithelium
研究概览
简要总结
To determine the efficacy and safety of nerve growth factor in the treatment of limbal stem cell deficiency (LSCD) associated with neurotrophic cornea.
详细描述
This is a prospective open-label pilot study evaluating the role of cenegermin-bkbj for the treatment of LSCD with associated neurotrophic keratopathy. Patient diagnosed with LSCD with neurotrophic cornea who have failed conventional treatment such as artificial tears are enrolled in the study after a 2 week washout period. Patient are then treated with cenegermin-bkbj over an 8 week period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients diagnosed with LSCD and neurotrophic cornea confirmed by testing with Cochet-Bonnet aesthesiometer
排除标准
- •Active ocular infection
- •Anticipated need for bandage contact lens, amniotic membrane graft, or tarsorrhaphy during the study period
- •Unable to discontinue the use of contact lens
- •Visual acuity worse than 20/200 in the better eye
结局指标
主要结局
Size of abnormal epithelium
时间窗: Baseline, week 8
Change in size of abnormal epithelium compared to baseline
次要结局
- Cornea sensation(Baseline, week 8)
- Number of patients with resolution of epithelial defect if present prior to treatment(Baseline, week 8)
研究者
Christopher Ta
Professor of Ophthalmology
Stanford University
研究点 (1)
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