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临床试验/NCT01633983
NCT01633983Unknown2 期

Phase 2 Study of Escalating Oral Methotrexate for Central Serous Chorioretinopathy

Edward Averbukh1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年8月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Chronic CSC will be given an immediate MTX treatment

干预措施: Methotrexate (Drug)

Delayed treatment

Experimental

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

发起方
Edward Averbukh
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Edward Averbukh

Head of Hadassah Mt Scopus Ophthalmology Center

Hadassah Medical Organization

研究点 (1)

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