NCT01822561已完成2 期
Eplerenone for Central Serous Chorioretinopathy: A Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Complete Resolution of Subretinal Fluid
研究概览
简要总结
- The goal of the study is to examine the short-term effects and safety of a systemic anti-aldosterone medication, eplerenone, in a small group of patients with central serous chorioretinopathy (CSCR).
- There is currently no standard treatment or therapy for either acute or chronic CSCR, a potentially debilitating eye disease.
- There is evidence in both animals and humans that high blood serum corticosteroid levels can cause or worsen CSCR or findings similar to CSCR in the choroid and retina
- 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 investigators' aim is to evaluate a standardized dose of eplerenone in a controlled prospective fashion for both acute and chronic CSCR.
- The study consists of taking a standard dose of eplerenone, 50mg once daily, for 1 month
- Over the course of the month, patients will be monitored for side effects, as well as visual and anatomical response to the medication
详细描述
- The investigators hypothesize that aldosterone inhibition with eplerenone will decrease choroidal vessel vasodilation, focal leakage, and choroidal thickness in patients with both acute and chronic CSCR, leading to resolution of subretinal fluid and ultimately an improvement in symptoms.
- Resolution of sub-retinal fluid will be the primary outcome, which can be precisely measured using optical coherence tomography (OCT)
- Secondary outcomes will include: Change in macular thickness measured with OCT, in central macular circle thickness on OCT, change in visual acuity, change in dye leakage characteristics on fluorescein angiography, change in OCT characteristics of the fellow eye, and safety and tolerability characteristics
- In acute CSCR, subretinal fluid often resolves on its own, but it often takes several months (the literature shows that ~20% of patients have complete resolution of sub-retinal fluid on OCT 1 month after presentation)
- Chronic CSCR is defined as persistent fluid on OCT after 3 months of symptom onset, or recurrence of signs and symptoms within 1 year after the prior episode
- In this study, the investigators will not make a distinction between acute and chronic CSCR
- Eplerenone, a generic medication, is a potassium sparing diuretic, which is FDA approved to treat heart failure as well as high blood pressure, but is not FDA approved for treatment of central serous chorioretinopathy.
- The most important side effect of eplerenone is elevation of serum potassium and decrease of blood pressure
- Patients will therefore be screened with routine blood tests as suggested by the package insert of the medication, and serum potassium and blood pressure will be monitored routinely as directed by the medication package insert
- Study visits will be performed at therapy initiation, 1 week, 2 weeks, and 4 weeks
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or over
- •Ability to give written informed consent
- •Presence of sub-retinal fluid under the fovea as seen on OCT
- •Diagnosis of Acute or Chronic CSCR:
- •Acute CSCR: First presentation to eye clinic with visual symptoms, including decreased vision or visual distortion, and the characteristic appearance of CSCR on examination, fluorescein angiography, and OCT.
- •Chronic CSCR: Previous diagnosis of CSCR, persistent subretinal fluid on OCT for more than 3 months after initial presentation to the eye clinic, and <50% reduction in fluid thickness on OCT after 3 months. Patients who have had previous treatment for CSCR may be included.
排除标准
- •Age less than 18
- •Persons with impaired decision-making ability.
- •Women who are known to be pregnant or are actively trying to conceive.
- •Additional eye disease affecting the macula or posterior retina.
- •At screening, serum potassium concentration ≥5.0 mEq/L , a serum creatinine concentration >2 mg/dL in men and >1.8 mg/dL in women, or a creatinine clearance <50 mL/min, and during concomitant administration of potassium supplements, potassium-sparing diuretics, and/or potent CYP3A4 inhibitors (amifostine, cyclosporine, fluconazole, itraconazole, ketoconazole, mifepristone, posaconazole, potassium salts, Rituximab, tacrolimus or voriconazole).
- •Patients with type 2 diabetes will be screened for microalbuminuria with a urinalysis. If microalbuminuria is present, these patients will be excluded.
研究组 & 干预措施
Eplerenone
Experimental
All patients in this study will receive Eplerenone 50mg once daily for 4 weeks.
干预措施: Eplerenone 50mg (Drug)
结局指标
主要结局
Complete Resolution of Subretinal Fluid
时间窗: Baseline and 1 month after treatment
Optical coherence tomography is an imaging technique capable of extremely high resolution (\~5-7 microns) imaging of the macula, and is able to detect the presence and amount of subretinal fluid present, the key anatomic abnormality in Central Serous Chorioretinopathy
次要结局
- Change in Macular Thickness(Baseline and 1 month after treatment)
- Change in Subfoveal Choroidal Thickness, Study Eye(Baseline and 1 month after treatment)
- Change in Best Corrected Visual Acuity(Baseline and 1 month after treatment)
- Change in Serum Potassium(Baseline and 1 month after treatment)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Eplerenone for the Treatment of Central Serous ChorioretinopathyCentral Serous ChorioretinopathyNCT01990677Wills Eye108
已完成
4 期
Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian PopulationChronic Central Serous ChorioretinopathyNCT02462499Semmelweis University28
已完成
不适用
Central Serous Chorioretinopathy Treated by Modified Photodynamic TherapyCentral Serous ChorioretinopathyNCT01019668Shin Kong Wu Ho-Su Memorial Hospital24
Unknown
2 期
Eplerenone For the Treatment of Chronic Central Serous ChorioretinopathyCentral Serous ChorioretinopathyNCT02153125Tel-Aviv Sourasky Medical Center30
已完成
1 期
Topical Interferon Gamma-1b for Central Serous ChorioretinopathyRetinal DiseaseMacular DiseaseNCT01468337National Eye Institute (NEI)5