A Pilot Study of The Treatment of Central Serous Chorioretinopathy With Ketoconazole.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Visual acuity (ETDRS) after 6 weeks of treatment
研究概览
简要总结
The purpose of this study is to determine the effect of an adrenocorticoid antagonist (ketoconazole), 600 mg per day for 4 weeks, in the treatment of patients with central serous chorioretinopathy (CSC).
详细描述
A complete ophthalmic evaluation and tests: autofluorescence and Fluorescein angiography, Color Fundus Photography, OCT, including liver and adrenal functions and pregnancy test, if applicable will be done on the screening visit. If the patient is eligible, the patient will be started on ketoconazole 600 mg per day by mouth for the following next 6 weeks. The patient will be rechecked at weeks 5-6, 10,14 and 18. During all these visits a complete ophthalmic examination autofluorescence, OCT, and color fundus photographs will be done.
Repeat Liver and Adrenal function tests will be done at weeks 5-6 and 10 visits.
On the exit visit, all the ophthalmic tests and procedures on the baseline visit will be done. Adverse events, and concomitant medications and treatments will be reported on all visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age less than 60 years
- •Must have clinical signs of CSC with leakage from the level of the RPE during fluorescein angiography and neurosensory detachment documented by optical coherence tomography (OCT).
- •Be able to return for all study visits for 3 months' duration.
- •Be able to provide written informed consent
- •Must have sufficiently clear media to allow for adequate fundus photography
排除标准
- •Have choroidal neovascularization.
- •Have any evidence of clinically significant intraocular inflammation, angioid streaks, presumed ocular histoplasmosis syndrome, or other precursor of choroidal neovascularization.
- •Have additional eye disease that compromises the visual acuity of the study eye.
- •Are receiving any systemic steroid therapy
- •Have any significant medical history
- •Have a history of severe hypersensitivity reaction to any of the dyes or the drug used in the study.
- •Have any history of ocular conditions that may mimic CSC
- •Are pregnant
研究组 & 干预措施
Drug: ketoconazole
Drug: ketoconazole
Other Names:
ketoconazole
600mg. /day for 6 weeks
干预措施: ketoconazole (Drug)
结局指标
主要结局
Visual acuity (ETDRS) after 6 weeks of treatment
时间窗: 18 weeks
次要结局
- Changes in the choroidal vascular pattern as observed on FA and changes at the posterior pole as measured with optical coherence tomography(18 weeks)
研究者
Joan
K. Bailey Freund, M.D.
Manhattan Eye, Ear & Throat Hospital