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Eplerenone for Central Serous Chorioretinopathy

Primary Purpose

Central Serous Chorioretinopathy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Eplerenone 50mg
Sponsored by
Tufts Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Serous Chorioretinopathy focused on measuring Central Serous Chorioretinopathy, Eplerenone, Optical Coherence Tomography, Enhanced Depth Imaging, Subretinal Fluid

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New England Eye Center / Tufts Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Eplerenone

Arm Description

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

Outcomes

Primary Outcome Measures

Complete Resolution of Subretinal Fluid
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

Secondary Outcome Measures

Change in Macular Thickness
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.
Change in Best Corrected Visual Acuity
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)
Change in Subfoveal Choroidal Thickness, Study Eye
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.
Change in Serum Potassium
Eplerenone can cause elevation of serum potassium. After initial screening, serum potassium was evaluated at 1 and 4 weeks after baseline.

Full Information

First Posted
March 25, 2013
Last Updated
April 17, 2018
Sponsor
Tufts Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01822561
Brief Title
Eplerenone for Central Serous Chorioretinopathy
Official Title
Eplerenone for Central Serous Chorioretinopathy: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Serous Chorioretinopathy
Keywords
Central Serous Chorioretinopathy, Eplerenone, Optical Coherence Tomography, Enhanced Depth Imaging, Subretinal Fluid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eplerenone
Arm Type
Experimental
Arm Description
All patients in this study will receive Eplerenone 50mg once daily for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Eplerenone 50mg
Other Intervention Name(s)
Inspra (Pfizer), Eplerenone (Generic)
Intervention Description
All patients will receive the same dose of eplerenone.
Primary Outcome Measure Information:
Title
Complete Resolution of Subretinal Fluid
Description
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
Secondary Outcome Measure Information:
Title
Change in Macular Thickness
Description
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
Title
Change in Best Corrected Visual Acuity
Description
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
Title
Change in Subfoveal Choroidal Thickness, Study Eye
Description
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
Title
Change in Serum Potassium
Description
Eplerenone can cause elevation of serum potassium. After initial screening, serum potassium was evaluated at 1 and 4 weeks after baseline.
Time Frame
Baseline and 1 month after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 or over Ability to give written informed consent Presence of sub-retinal fluid under the fovea as seen on OCT 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: Age less than 18 Persons with impaired decision-making ability. Women who are known to be pregnant or are actively trying to conceive. Additional eye disease affecting the macula or posterior retina. 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). Patients with type 2 diabetes will be screened for microalbuminuria with a urinalysis. If microalbuminuria is present, these patients will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre J Witkin, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
New England Eye Center / Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Eplerenone for Central Serous Chorioretinopathy

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