Retrobulbar Injection of Autoserum in the Treatment of Retinitis Pigmentosa: A Prospective, Non-randomized Interventional Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- Change of the visual acuity
研究概览
简要总结
This study is designed to assess and to evaluate the therapeutic effect of retrobulbar injection of autoserum in the treatment of retinitis pigmentosa.
详细描述
The retinitis pigmentosa(RP) is an hereditary disease which causes visual deficiency leading to blindness. The methods of treatment include gene therapy, stem cell therapy and visual prothesis, etc. But all these methods own limitations can not be conquered in a short period. It was proved that vascular endothelial growth factor (VEGF) and pigment epithelium derived factor (PEDF) decreased in the aqueous humor of patients of RP. But the traditional exogenous nerve growth factors (NGFs) were immunogenic proteins and may cause inflammation. Autoserum contain a large amount of active factors and will not cause exclusive reaction. In this study we aim to assess and to evaluate the therapeutic effect and the safety of retrobulbar injection of autoserum in the treatment of retinitis pigmentosa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of retinitis pigmentosa
排除标准
- •Suspected glaucoma, suspected optic nerve disease, blindness due to other ocular disease
- •Combined with serious systemic disease
- •Can not cooperate with the interventions and examinations.
结局指标
主要结局
Change of the visual acuity
时间窗: one day before injection, one day, one month, three months and six months after surgery
To measure the visual acuity with logarithmic visual chart.
Change of the electrophysiological detection (electro-oculogram)
时间窗: one day before injection, three months and six months after surgery
To evaluate the retinal function with the use of electro-oculogram (EOG)
Change of the contrast sensitivity
时间窗: one day before injection, one month, three months and six months after surgery
To access the change of contrast sensitivity in different special frequency.
Change of the electrophysiological detection (flash electroretinogram)
时间窗: one day before injection, three months and six months after surgery
To evaluate the retinal function with the use of flash electroretinogram (F-ERG).
次要结局
未报告次要终点