Eplerenone for Central Serous Chorioretinopathy

April 17, 2018 updated by: Tufts Medical Center

Eplerenone for Central Serous Chorioretinopathy: A Pilot Study

  • 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • New England Eye Center / Tufts Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eplerenone
All patients in this study will receive Eplerenone 50mg once daily for 4 weeks.
Drug: Eplerenone 50mg
All patients will receive the same dose of eplerenone.
Other Names:
  • Inspra (Pfizer)
  • Eplerenone (Generic)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Resolution of Subretinal Fluid
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
Baseline and 1 month after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Macular Thickness
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.
Baseline and 1 month after treatment
Change in Best Corrected Visual Acuity
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)
Baseline and 1 month after treatment
Change in Subfoveal Choroidal Thickness, Study Eye
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.
Baseline and 1 month after treatment
Change in Serum Potassium
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.
Baseline and 1 month after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts Medical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

March 25, 2013

First Submitted That Met QC Criteria

April 1, 2013

First Posted (Estimate)

April 2, 2013

Study Record Updates

Last Update Posted (Actual)

May 16, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEEC-10722

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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