Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population

Phase 4

Completed

• Conditions: Chronic Central Serous Chorioretinopathy
• Interventions: Drug: Inspra (eplerenone)

• Registration Number: NCT02462499
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-05-26
• Study First Submitted QC: 2015-06-03
• Study First Posted: 2015-06-04
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-15
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Inspra (eplerenone)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Semmelweis University, Department of Ophthalmology; 🇭🇺 Budapest, Hungary