A Repeated Measures Study of Simvastatin on Choroideremia: Simvastatin Intervention and Reversal in Choroideremia Patients and Age-matched Controls.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Full-field scotopic threshold
研究概览
简要总结
Primary objective: To examine the short-term effects of of simvastatin on the vision on males with choroideremia, evaluated by full-field scotopic threshold testing. The investigators hypothesize that they will see a reversible decrease in the dark-adapted vision in participants taking simvastatin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Participant is willing and able to give informed consent for participation in the study
- •Diagnosed with choroideremia and in good health
- •Willing to allow his general practitioner and consultant, if appropriate, to be notified of participation in the study
- •Over age of 18 years
排除标准
- •Significant health disease, disorder, or medication, which, in the opinion of the investigator, would put the patient at risk if he were to take simvastatin
- •Already taking simvastatin or another statin
研究组 & 干预措施
CHM
Administration of 40mg simvastatin daily, orally for 5 weeks (4-6 weeks window), followed by 5 week (4-6 week window) washout period.
干预措施: Simvastatin (Drug)
Age-matched controls
Administration of 40mg simvastatin daily, orally for 5 weeks (4-6 weeks window), followed by 5 week (4-6 week window) washout period.
干预措施: Simvastatin (Drug)
结局指标
主要结局
Full-field scotopic threshold
时间窗: 5 weeks (4-6 weeks)
Full-field scotopic threshold measured at 4-6 weeks after simvastatin administration.
次要结局
- Full-field scotopic threshold(5 weeks (4-6 weeks))
- Microperimetry, OCT, fundus autofluorescence, ERG, VA(5 weeks (4-6 weeks))