The Effect of L-Dopa on the Progression of Retinitis Pigmentosa
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Electroretinogram
研究概览
简要总结
The purpose of this study is to evaluate the effect of L-Dopa on the progression of retinitis pigmentosa.
详细描述
Retinitis pigmentosa is a group of progressive hereditary diseases that diffusely affects the functioning of photoreceptors and the pigment epithelium. It may be speculated that a protective effect on the pigment epithelium, as it is supposed for L-Dopa, can slow the progression of the disease or even lead to an, at least transient, improvement of visual functions. To evaluate the effect of L-Dopa on retinitis pigmentosa progression, visual acuity, electroretinogram and visual field will be preformed regularly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All confirmed cases of retinitis pigmentosa
- •VA of 20/400 or better
排除标准
- •Advanced stages of retinitis pigmentosa with poor best corrected visual acuity (less than 20/400)
- •co-existing eye morbidities interfering with retinitis pigmentosa (glaucoma, retinal detachment...)
- •Flat electroretinogram
- •Intolerance or counterindication to drug
- •Unability for long-term follow-up
研究组 & 干预措施
Treatment
This is a single armed study. All patients included will receive treatment. Control will happen with data from the same patients before they received treatment.
patients will receive sinemet 200/50 1/2 tablet (levodopa-carbidopa 100/25) b.i.d for two days and then will be increased to t.i.d. for 6 months.
干预措施: levodopa-carbidopa (Drug)
结局指标
主要结局
Change in Electroretinogram
时间窗: Baseline, 1 year, 2 years, 5 years
the electric response to light stimuli of the retina, in millivolt, will be measured. The electroretinogram shows a-waves (elicit information about the function of the photoreceptors) and b-waves (elicit information about other neurosensory structure of the retina)
次要结局
- Change in Visual Field(Baseline, 1 year, 2 years, 5 years)
- Change in Visual Acuity(Baseline, 6 months, 1 year, 2 years, 5 years)