Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population

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Central serous chorioretinopathy
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Brief Title

Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population

Official Title

Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population

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.

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Resolution of sub-retinal fluid measured by optical coherence tomography (OCT).

Secondary Outcome

 Changes in macular volume at baseline, during and after the treatment with eplerenone.

Condition

Chronic Central Serous Chorioretinopathy

Intervention

Inspra (eplerenone)

Study Arms / Comparison Groups

 Treatment
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

28

Start Date

June 2014

Completion Date

September 2016

Primary Completion Date

September 2016

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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

Hungary

Location Countries

Hungary

Administrative Informations

NCT ID

NCT02462499

Organization ID

CSCR 104/2014

Responsible Party

Principal Investigator

Study Sponsor

Semmelweis University

Study Sponsor

, ,

Verification Date

October 2016