Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population

NCT ID: NCT02462499

Last Updated: 2016-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Central Serous Chorioretinopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Inspra (eplerenone)

Intervention Type DRUG

Interventions

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Inspra (eplerenone)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Semmelweis University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Ecsedy

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Semmelweis University, Department of Ophthalmology

Budapest, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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CSCR 104/2014

Identifier Type: -

Identifier Source: org_study_id

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