Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2014
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 26, 2015
CompletedFirst Posted
Study publicly available on registry
June 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedOctober 18, 2016
October 1, 2016
2.3 years
May 26, 2015
October 15, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Changes in macular volume at baseline, during and after the treatment with eplerenone.
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
Changes in choroideal thickness at baseline measured by OCT, during and after the treatment with eplerenone in both eyes.
6 months
Study Arms (1)
Treatment
EXPERIMENTALTreatment: 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.
Interventions
Eligibility Criteria
You may qualify if:
- Chronic central serous chorioretinopathy (CSCR) with persistent subretinal fluid on OCT for more than 3 months after initial presentation .
- Written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Semmelweis University, Department of Ophthalmology
Budapest, 1085, Hungary
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 26, 2015
First Posted
June 4, 2015
Study Start
June 1, 2014
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
October 18, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share