NCT02153125Unknown2 期
Eplerenone For the Treatment of Chronic Central Serous Chorioretinopathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Decrease of at least 10% in subretinal fluid thickness as 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 in treating patients with chronic central serous chorioretinopathy with the drug eplerenone.
详细描述
- The goal of the study is to examine the short-term effects and safety of eplerenone, a systemic anti-aldosterone medication, in a group of patients with central serous chorioretinopathy (CSCR).
- There is currently no standard treatment or therapy for chronic CSCR, a potentially debilitating eye disease.
- There is evidence that high blood serum corticosteroid levels can cause or worsen CSCR
- Eplerenone, a mineralocorticoid receptor antagonist, has been shown to be of visual and anatomic benefit in a small series of 4 patients with chronic CSCR, suggesting that decreasing mineralocorticoid action in the eye may improve signs and symptoms of CSCR
- The study's aim is to evaluate a standardized dose of eplerenone in a controlled prospective fashion for chronic CSCR.
- The study consists of taking a standard dose of eplerenone, 25mg once daily for a week, followed by 50mg once daily, for a total of 3 months
- Patients will be monitored for efficacy and side effects from the beginning of treatment and for 6 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic central serous chorioretinopathy (CSCR): Previous diagnosis of CSCR, persistent subretinal fluid on OCT for more than 4 months after initial presentation to the eye clinic
排除标准
- •Other retinal disease
- •Choroidal neovascularization
- •A history of uveitis
- •Ocular surgery in the prior 3 months
- •Allergy to fluorescein or indocyanine green
- •Pregnancy, lactation or female patients in fertility age not treated with contraceptive pills
- •Creatinine clearance < 50 ml/min
- •Hyperkalemia > 5 mmol/l
- •Patients treated with drugs deactivated by cytochrome P450 3A4 (CYP3A4)
- •Serum creatinine > 2 mg/dl in men or > 1.8 mg/dl in women
- •Treatment with potassium sparing agents or potassium
- •Treatment with Angiotensin converting enzyme (ACE)/angiotensin II receptor blocker (ARB) inhibitors
研究组 & 干预措施
Eplerenone
Experimental
25mg eplerenone given daily for a week, followed by 50mg given for a total of 3 months since commencement of treatment
干预措施: Eplerenone (Drug)
结局指标
主要结局
Decrease of at least 10% in subretinal fluid thickness as measured by optical coherence tomography (OCT)
时间窗: 6 months
次要结局
未报告次要终点
研究者
Michaella Goldstein
Deputy Head Department of Ophthalmology
Tel-Aviv Sourasky Medical Center
研究点 (1)
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