Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population

Chronic Central Serous Chorioretinopathy Clinical Trial

Official title:

Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02462499
• Other study ID #: CSCR 104/2014
• Status: Completed
• Phase: Phase 4
• First received: May 26, 2015
• Last updated: October 15, 2016
• Start date: June 2014
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: Scientific and Medical Research Council Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy
• Chronic Central Serous Chorioretinopathy

Intervention

Drug:
• Inspra (eplerenone)

Locations

Country	Name	City	State
Hungary	Semmelweis University, Department of Ophthalmology	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of sub-retinal fluid measured by optical coherence tomography (OCT).		6 months	No
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability.		3 months	Yes
Secondary	Changes in macular volume at baseline, during and after the treatment with eplerenone.		6 months	No
Secondary	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	No
Secondary	Changes in choroideal thickness at baseline measured by OCT, during and after the treatment with eplerenone in both eyes.		6 months	No