Eplerenone for Central Serous Chorioretinopathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Tufts Medical Center
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT01822561
First received: March 25, 2013
Last updated: December 10, 2013
Last verified: December 2013
  Purpose
  • 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

Condition Intervention Phase
Central Serous Chorioretinopathy
Drug: Eplerenone 50mg
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Eplerenone for Central Serous Chorioretinopathy: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • Resolution of Sub-retinal Fluid [ Time Frame: Baseline and 1 month after treatment ] [ Designated as safety issue: No ]
    Optical coherence tomography (OCT) 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


Secondary Outcome Measures:
  • Change in macular thickness [ Time Frame: Baseline and 1 month after treatment ] [ Designated as safety issue: No ]
    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.

  • Best Corrected Visual Acuity [ Time Frame: Baseline and 1 month after treatment ] [ Designated as safety issue: No ]
    Visual acuity will be measured with standard ETDRS 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)

  • Change in choroidal thickness, both eyes [ Time Frame: Baseline and 1 month after treatment ] [ Designated as safety issue: No ]
    Choroidal thickness can be measured using OCT, and is known to be affected in patients with central serous chorioretinopathy. OCT characteristics may be affected in the fellow eye. Thickness of the choroid under the fovea will be manually calculated in both the study eye and the fellow eye.

  • Safety and Tolerability Characteristics [ Time Frame: Baseline and 1 month after treatment ] [ Designated as safety issue: Yes ]
    Eplerenone can cause elevation of serum potassium, cholesterol, and LFT's, as well as decrease the blood pressure. After initial screening, serum potassium and creatinine will be evaluated at 1 and 4 weeks after baseline. Additional serum tests of electrolytes, liver function tests, uric acid, and a fasting cholesterol panel will be obtained before treatment and 4 weeks after baseline. Adverse and Serious Adverse Events will be recorded and reported to the Institutional Review Board.


Estimated Enrollment: 20
Study Start Date: May 2013
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01822561

Locations
United States, Massachusetts
New England Eye Center / Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Andre J Witkin, MD    617-646-7950    awitkin@tuftsmedicalcenter.org   
Contact: Julie Burt    617-636-0747    jburt@tuftsmedicalcenter.org   
Principal Investigator: Andre J Witkin, MD         
Sub-Investigator: Jay S Duker, MD         
Sub-Investigator: Elias Reichel, MD         
Sub-Investigator: Caroline R Baumal, MD         
Sub-Investigator: Adam R Rogers, MD         
Sub-Investigator: Nadia K Waheed, MD         
Sub-Investigator: Roger Goldberg, MD         
Sub-Investigator: Marissa Weber, MD         
Sub-Investigator: Jordana Fein, MD         
Sponsors and Collaborators
Tufts Medical Center
  More Information

Publications:

Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT01822561     History of Changes
Other Study ID Numbers: NEEC-10722
Study First Received: March 25, 2013
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts Medical Center:
Central Serous Chorioretinopathy
Eplerenone
Optical Coherence Tomography
Enhanced Depth Imaging
Subretinal Fluid

Additional relevant MeSH terms:
Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases
Eplerenone
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014