NCT02462499已完成4 期
Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Resolution of sub-retinal fluid measured by optical coherence tomography (OCT).
研究概览
简要总结
The aim of the study is to determine the efficacy and safety of treatment with the drug eplerenone in patients with chronic central serous chorioretinopathy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic central serous chorioretinopathy (CSCR) with persistent subretinal fluid on OCT for more than 3 months after initial presentation .
- •Written informed consent
排除标准
- •Persons with impaired decision-making ability.
- •Pregnant women or who are actively trying to conceive.
- •Additional eye disease affecting the macula or posterior retina.
- •Creatinine clearance < 50 ml/min
- •Hyperkalemia > 5 mmol/l
- •Serum creatinine > 2 mg/dl in men or > 1.8 mg/dl in women
- •Treatment with potassium sparing agents or potassium
- •Treatment with any other drugs known to cause interaction with eplerenone
- •Microalbuminuria in patients with type 2 diabetes
研究组 & 干预措施
Treatment
Experimental
Treatment: Eplerenone (Inspra) All patients will receive 25mg eplerenone once a day for a week, followed by 50mg once a day, for a total of 4-12 weeks.
干预措施: Inspra (eplerenone) (Drug)
结局指标
主要结局
Resolution of sub-retinal fluid measured by optical coherence tomography (OCT).
时间窗: 6 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
时间窗: 3 months
次要结局
- Changes in macular volume at baseline, during and after the treatment with eplerenone.(6 months)
- Changes in choroideal thickness at baseline measured by OCT, during and after the treatment with eplerenone in both eyes.(6 months)
- Changes in visual acuity at baseline measured on Early Treatment of Diabetic Retinopathy Study (ETDRS) chart, during and after the treatment with eplerenone.(6 months)
研究者
Dr. Ecsedy
Assistant Professor
Semmelweis University
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Eplerenone For the Treatment of Chronic Central Serous ChorioretinopathyCentral Serous ChorioretinopathyNCT02153125Tel-Aviv Sourasky Medical Center30
已完成
不适用
Eplerenone for the Treatment of Central Serous ChorioretinopathyCentral Serous ChorioretinopathyNCT01990677Wills Eye108
已完成
2 期
Eplerenone for Central Serous ChorioretinopathyCentral Serous ChorioretinopathyNCT01822561Tufts Medical Center17
招募中
1 期
Evaluation of the effect of Eplerenone in Central serous chorioretinopathy )CSCRCentral serous chorioretinopathyIRCT20220122053792N1Oroumia University of Medical Sciences34
已完成
4 期
The Purpose of This Study is to Determine if Eplerenone is Effective in Treatment of Mild to Moderate Heart FailureHeart Failure, CongestiveNCT00082589Pfizer's Upjohn has merged with Mylan to form Viatris Inc.250