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Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02462499
Recruitment Status : Completed
First Posted : June 4, 2015
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Ecsedy, Semmelweis University

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.

Condition or disease Intervention/treatment Phase
Chronic Central Serous Chorioretinopathy Drug: Inspra (eplerenone) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population
Study Start Date : June 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Eplerenone

Arm Intervention/treatment
Experimental: Treatment
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.
Drug: Inspra (eplerenone)



Primary Outcome Measures :
  1. Resolution of sub-retinal fluid measured by optical coherence tomography (OCT). [ Time Frame: 6 months ]
  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability. [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Changes in macular volume at baseline, during and after the treatment with eplerenone. [ Time Frame: 6 months ]
  2. 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 ]
  3. Changes in choroideal thickness at baseline measured by OCT, during and after the treatment with eplerenone in both eyes. [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462499


Locations
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Hungary
Semmelweis University, Department of Ophthalmology
Budapest, Hungary, 1085
Sponsors and Collaborators
Semmelweis University
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Responsible Party: Dr. Ecsedy, Assistant Professor, Semmelweis University
ClinicalTrials.gov Identifier: NCT02462499    
Other Study ID Numbers: CSCR 104/2014
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases
Eplerenone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Antihypertensive Agents