Eplerenone for the Treatment of Central Serous Chorioretinopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Mean Change in Maximal Subretinal Fluid Height Based on Spectral Domain Optical Coherence Tomography (OCT) Measurement.
研究概览
简要总结
To test the effect oral eplerenone versus placebo in patients with central serious chorioretinopathy .
详细描述
To evaluate the effect of oral eplerenone compared to placebo in patients with central serous chorioretinopathy (CSCR) on sub-foveal (small part of retina) fluid using optical coherence tomography (OCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Age 18 and over
- •Ability to give written informed consent
- •Sub-retinal fluid under fovea seen on OCT
- •Diagnosis of central serous chorioretinopathy (CSCR): classification is at the discretion of the investigator, but general guidelines are
- •Acute- first episode or symptoms less than one month prior to presentation
- •Chronic- previously documented sub-foveal fluid, any prior treatment, symptoms for over 3 months, or <50% reduction in fluid thickness on OCT after 3 months.
排除标准
- •Age under 18
- •Impaired decision-making ability
- •At initial laboratory screening serum potassium >5.5 milliequivalent (mEq)/L
- •At initial laboratory screening serum creatinine >2 mg/dL in men and >1.8 mg/dL in women or decreased renal function by creatinine clearance less than 50 mL/min
- •Absence of sub-foveal fluid
- •Any patient with prior treatment for CSCR within 3 months of enrollment
- •Patients taking potassium supplements or potassium-sparing diuretics spironolactone, amiloride, and triamterene and/or potent CYP3A4 (cytochrome) inhibitors (amifostine, cyclosporine, fluconazole, itraconazole, ketoconazole, mifepristone, posaconazole, potassium salts, rituximab, tacrolimus, voriconazole nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir)
- •Women who are pregnant or are actively trying to conceive
- •Patients with type 1 or type 2 diabetes
研究组 & 干预措施
25mg Eplerenone- Chronic CSCR Diagnosis
Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 58 days. Throughout the 58 day treatment period dosage will be adjusted. The adjustment will be based on serum potassium and creatine levels from blood draws done at Day 12 and Day 33. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day.
干预措施: 25mg Eplerenone (Drug)
25mg Eplerenone- Chronic CSCR Diagnosis
Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 58 days. Throughout the 58 day treatment period dosage will be adjusted. The adjustment will be based on serum potassium and creatine levels from blood draws done at Day 12 and Day 33. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day.
干预措施: Placebo (Drug)
Placebo- Chronic CSCR Diagnosis
Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 58 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient.
干预措施: Placebo (Drug)
25mg Eplerenone- Acute CSCR Diagnosis
Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 28 days. Throughout the 28 day treatment period, dosage will be adjusted based on serum potassium and creatine levels from blood draws done on Day 12. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day.
干预措施: 25mg Eplerenone (Drug)
25mg Eplerenone- Acute CSCR Diagnosis
Dosing will begin at 25mg Eplerenone taken orally , one time, each day for 28 days. Throughout the 28 day treatment period, dosage will be adjusted based on serum potassium and creatine levels from blood draws done on Day 12. From the 25 mg starting dosage, the dosage will either be increased to 50 mg a day or reduced to placebo, one time, each day.
干预措施: Placebo (Drug)
Placebo- Acute CSCR Diagnosis.
Dosing will begin with placebo and will stay as placebo throughout the study. The placebo pills will be taken orally, once daily, for 28 days. The placebo pills will be compounded to be of similar composition to the eplerenone tablets, without the active ingredient.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change in Maximal Subretinal Fluid Height Based on Spectral Domain Optical Coherence Tomography (OCT) Measurement.
时间窗: Baseline and 2 months
Mean change in maximal subretinal fluid height based on spectral domain OCT from baseline to month 2 in chronic central serous chorioretinopathy (CSCR) patients receiving placebo versus eplerenone.
次要结局
- Mean Change in Subfoveal Fluid Height Based on OCT Measurement(Baseline and Month 2)
研究者
MidAtlantic Retina
Dr. Mitchell Fineman
Wills Eye