Ignite Creation Date:
2025-12-24 @ 12:11 PM
Ignite Modification Date:
2026-01-01 @ 9:39 PM
Study NCT ID:
NCT01822561
Status:
COMPLETED
Last Update Posted:
2018-05-16
First Post:
2013-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Eplerenone for Central Serous Chorioretinopathy
Sponsor:
Tufts Medical Center
Organization:
Study Overview
Official Title:
Eplerenone for Central Serous Chorioretinopathy: A Pilot Study
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
* 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
* 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
Detailed Description:
* 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
* 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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: