Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population

October 15, 2016 updated by: Dr. Ecsedy, Semmelweis University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 4

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

  • Hungary
      • Budapest, Hungary, 1085
        • Semmelweis University, Department of Ophthalmology

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in macular volume at baseline, during and after the treatment with eplerenone.
Time Frame: 6 months
6 months
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
6 months
Changes in choroideal thickness at baseline measured by OCT, during and after the treatment with eplerenone in both eyes.
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Semmelweis University

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

June 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

May 26, 2015

First Submitted That Met QC Criteria

June 3, 2015

First Posted (Estimate)

June 4, 2015

Study Record Updates

Last Update Posted (Estimate)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 15, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSCR 104/2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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