Back to resultsEplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population
Primary Purpose
Chronic Central Serous Chorioretinopathy
Status
Completed
Phase
Phase 4
Locations
Hungary
Study Type
Interventional
Intervention
Inspra (eplerenone)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Central Serous Chorioretinopathy
Eligibility Criteria
Inclusion Criteria:
- Chronic central serous chorioretinopathy (CSCR) with persistent subretinal fluid on OCT for more than 3 months after initial presentation .
- Written informed consent
Exclusion Criteria:
- Persons with impaired decision-making ability.
- Pregnant women or who are actively trying to conceive.
- Additional eye disease affecting the macula or posterior retina.
- Creatinine clearance < 50 ml/min
- Hyperkalemia > 5 mmol/l
- Serum creatinine > 2 mg/dl in men or > 1.8 mg/dl in women
- Treatment with potassium sparing agents or potassium
- Treatment with any other drugs known to cause interaction with eplerenone
- Microalbuminuria in patients with type 2 diabetes
Sites / Locations
- Semmelweis University, Department of Ophthalmology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Treatment: Eplerenone (Inspra) All patients will receive 25mg eplerenone once a day for a week, followed by 50mg once a day, for a total of 4-12 weeks.
Outcomes
Primary Outcome Measures
Resolution of sub-retinal fluid measured by optical coherence tomography (OCT).
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
Secondary Outcome Measures
Changes in macular volume at baseline, during and after the treatment with eplerenone.
Changes in visual acuity at baseline measured on Early Treatment of Diabetic Retinopathy Study (ETDRS) chart, during and after the treatment with eplerenone.
Changes in choroideal thickness at baseline measured by OCT, during and after the treatment with eplerenone in both eyes.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02462499
Brief Title
Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population
Official Title
Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Semmelweis University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to determine the efficacy and safety of treatment with the drug eplerenone in patients with chronic central serous chorioretinopathy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Central Serous Chorioretinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Treatment: Eplerenone (Inspra) All patients will receive 25mg eplerenone once a day for a week, followed by 50mg once a day, for a total of 4-12 weeks.
Intervention Type
Drug
Intervention Name(s)
Inspra (eplerenone)
Primary Outcome Measure Information:
Title
Resolution of sub-retinal fluid measured by optical coherence tomography (OCT).
Time Frame
6 months
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Changes in macular volume at baseline, during and after the treatment with eplerenone.
Time Frame
6 months
Title
Changes in visual acuity at baseline measured on Early Treatment of Diabetic Retinopathy Study (ETDRS) chart, during and after the treatment with eplerenone.
Time Frame
6 months
Title
Changes in choroideal thickness at baseline measured by OCT, during and after the treatment with eplerenone in both eyes.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic central serous chorioretinopathy (CSCR) with persistent subretinal fluid on OCT for more than 3 months after initial presentation .
Written informed consent
Exclusion Criteria:
Persons with impaired decision-making ability.
Pregnant women or who are actively trying to conceive.
Additional eye disease affecting the macula or posterior retina.
Creatinine clearance < 50 ml/min
Hyperkalemia > 5 mmol/l
Serum creatinine > 2 mg/dl in men or > 1.8 mg/dl in women
Treatment with potassium sparing agents or potassium
Treatment with any other drugs known to cause interaction with eplerenone
Microalbuminuria in patients with type 2 diabetes
Facility Information:
Facility Name
Semmelweis University, Department of Ophthalmology
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population
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