Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population

• Sponsor: Semmelweis University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02462499
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arm: 1
• Duration (Months): 27
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Central Serous Chorioretinopathy	Drug: Inspra (eplerenone)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population
• Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Resolution of sub-retinal fluid measured by optical coherence tomography (OCT). [6 months]

2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability. [3 months]

Secondary Outcome Measures

1. Changes in macular volume at baseline, during and after the treatment with eplerenone. [6 months]

2. 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]

3. Changes in choroideal thickness at baseline measured by OCT, during and after the treatment with eplerenone in both eyes. [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Semmelweis University, Department of Ophthalmology	Budapest		Hungary	1085

Sponsors and Collaborators

• Semmelweis University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Ecsedy, Assistant Professor, Semmelweis University
• ClinicalTrials.gov Identifier: NCT02462499
• Other Study ID Numbers: CSCR 104/2014
• First Posted: Jun 4, 2015
• Last Update Posted: Oct 18, 2016
• Last Verified: Oct 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Central Serous Chorioretinopathy; Eplerenone

Study Results

No Results Posted as of Oct 18, 2016