Eplerenone for Central Serous Chorioretinopathy
Condition: Central Serous Chorioretinopathy
MeSH terms: Central Serous Chorioretinopathy
Study type: Interventional
Phase: Phase 2

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
    

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
    

Intervention name(s): Eplerenone 50mg
Intervention type(s): Drug
Intervention description(s): All patients will receive the same dose of eplerenone.
Other intervention name(s): Inspra (Pfizer); Eplerenone (Generic)
Intervention MeSH terms: Eplerenone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Central Serous Chorioretinopathy; Eplerenone; Optical Coherence Tomography; Enhanced Depth Imaging; Subretinal Fluid