Phase 2 Study of Escalating Oral Methotrexate for Central Serous Chorioretinopathy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Optical Coherence Tomography indicating the level of central serous detachment
研究概览
简要总结
Central serous chorioretinopathy (CSC) is a disease of unknown origin however multiple reports have indicated correlation of appearance of CSC with exposure to exogenous or elevated levels of endogenous corticosteroid. Since the level of endogenous corticosteroids is upregulated in many inflammatory conditions, control of the inflammation may be beneficial in reducing this level thus eliminating the stimulus for CSC. Methotrexate (MTX) is widely used to control different types of inflammation. The investigators are going to try an escalating doses of MTX to treat CSC under full medical supervision.
详细描述
Central serous chorioretinopathy (CSC) is a disease of unknown origin usually affecting the center of the macula in adults of working age. Though previously the condition was considered stress-related, multiple recent reports have indicated correlation of appearance of CSC with exposure to exogenous or elevated levels of endogenous corticosteroid. Since the level of endogenous corticosteroids is upregulated in many inflammatory conditions, control of the inflammation may downregulate the endogenous steroids thus eliminating the stimulus for CSC. Methotrexate (MTX) is widely used to control different types of inflammation. Few short retrospective series of beneficial effect of MTX on CSC were reported recently. The investigators are going to try an escalating doses of MTX to treat CSC under full medical supervision in a prospective manner.
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
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Central Serous Chorioretinopathy
排除标准
- •Pregnancy
- •Liver disease
- •Kidney disease
- •Steroid use
研究组 & 干预措施
Methotrexate
Chronic CSC will be given an immediate MTX treatment
干预措施: Methotrexate (Drug)
Delayed treatment
Acute CSC will be followed for 3 months for a spontaneous resolution before the treatment is offered
干预措施: Delayed treatment (Drug)
结局指标
主要结局
Optical Coherence Tomography indicating the level of central serous detachment
时间窗: 2 years
次要结局
未报告次要终点
研究者
Edward Averbukh
Head of Hadassah Mt Scopus Ophthalmology Center
Hadassah Medical Organization
