Eplerenone for Central Serous Chorioretinopathy

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Brief Title

Eplerenone for Central Serous Chorioretinopathy

Official Title

Eplerenone for Central Serous Chorioretinopathy: A Pilot Study

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
    

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
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Complete Resolution of Subretinal Fluid

Secondary Outcome

 Change in Macular Thickness

Condition

Central Serous Chorioretinopathy

Intervention

Eplerenone 50mg

Study Arms / Comparison Groups

 Eplerenone
Description:  All patients in this study will receive Eplerenone 50mg once daily for 4 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

17

Start Date

May 2013

Completion Date

December 2017

Primary Completion Date

April 2017

Eligibility Criteria

        Inclusion Criteria:

          1. Age 18 or over

          2. Ability to give written informed consent

          3. Presence of sub-retinal fluid under the fovea as seen on OCT

          4. 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.

        Exclusion Criteria:

          1. Age less than 18

          2. Persons with impaired decision-making ability.

          3. Women who are known to be pregnant or are actively trying to conceive.

          4. Additional eye disease affecting the macula or posterior retina.

          5. 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).

          6. Patients with type 2 diabetes will be screened for microalbuminuria with a urinalysis.
             If microalbuminuria is present, these patients will be excluded.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Andre J Witkin, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01822561

Organization ID

NEEC-10722


Responsible Party

Sponsor

Study Sponsor

Tufts Medical Center


Study Sponsor

Andre J Witkin, MD, Principal Investigator, Tufts Medical Center


Verification Date

April 2018