New England Eye Center / Tufts Medical Center
Boston, Massachusetts, 02111, United States
NCT Number: NCT01822561
* 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
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Notify Me18 year–65 year
All sexes
Interventional
Phase 2
Boston, Massachusetts, 02111, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All patients will receive the same dose of eplerenone.
Other names: Inspra (Pfizer), Eplerenone (Generic)
Time frame: 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
Time frame: Baseline and 1 month after treatment
Automated software to calculate the thickness of the macula is standard on commercial OCT devices. Macular thickness before and after treatment will be assessed and compared.
Time frame: Baseline and 1 month after treatment
Visual acuity will be measured with standard eye charts, with manifest refraction at the initiation and conclusion of treatment. Although an important measure, this was not chosen as the primary outcome measure, as some patients with central serous chorioretinopathy may have a normal visual acuity when properly refracted (refraction can change with elevation of the macula by sub-retinal fluid)
Time frame: Baseline and 1 month after treatment
Choroidal thickness can be measured using optical coherence tomography, and is known to be affected in patients with central serous chorioretinopathy. Thickness of the choroid under the fovea will be manually calculated in both the study eye.
Time frame: Baseline and 1 month after treatment
Eplerenone can cause elevation of serum potassium. After initial screening, serum potassium was evaluated at 1 and 4 weeks after baseline.
Tufts Medical Center
Other
Eplerenone for Central Serous Chorioretinopathy: A Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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