Structural and Functional Changes of Corneal Innervation After Treatment With Cenegermin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in corneal nerve fiber density (CNFD)
研究概览
简要总结
Neurotrophic keratopathy (NK) is a condition in which patients have fewer or complete absence of nerves in the cornea, characterized by the reduced or absent corneal sensation. The lack of nerves in the cornea also result in damages of the cornea and in severe situation the loss of the eye.
Cenegermin (trade name Oxervate) is a nerve growth factor eye drops designed to treat NK, and currently, it is the only FDA-approved medication for this purpose.
Even though cenegermin is effective in the majority of patients, there is a lack of understanding of how cenegermin works in the eye.
In this study, investigators aim to determine the structural and functional effects of cenegermin on the cornea, using non-invasive technologies including in vivo confocal microscopy on study participants with NK over the course of a year.
详细描述
Cenegermin (OxervateTM) is a recombinant human form of nerve growth factor developed by Dompé Farmaceutici S.p.A. for patients who are diagnosed with corneal epithelial defects due to moderate to severe stages of NK.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Patient Population
Patients diagnosed with neurotrophic keratopathy.
干预措施: Cenegermin Ophthalmic Solution [Oxervate] (Drug)
结局指标
主要结局
Change in corneal nerve fiber density (CNFD)
时间窗: 1 year
To determine the changes in corneal nerve fiber density (CNFD), assessed by in vivo confocal microscopy.
次要结局
- Duration of changes in CNFD(1 year)
研究者
Simon Fung
Principal Investigator
University of California, San Francisco