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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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24 October 2016 |
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Main ID: |
NCT02462499 |
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Date of registration:
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26/05/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population
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Scientific title:
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Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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28 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02462499 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Hungary
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Central Serous Chorioretinopathy
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Intervention(s)
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Drug: Inspra (eplerenone)
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Primary Outcome(s)
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Resolution of sub-retinal fluid measured by optical coherence tomography (OCT).
[Time Frame: 6 months]
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Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
[Time Frame: 3 months]
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Secondary Outcome(s)
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Changes in visual acuity at baseline measured on Early Treatment of Diabetic Retinopathy Study (ETDRS) chart, during and after the treatment with eplerenone.
[Time Frame: 6 months]
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Changes in choroideal thickness at baseline measured by OCT, during and after the treatment with eplerenone in both eyes.
[Time Frame: 6 months]
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Changes in macular volume at baseline, during and after the treatment with eplerenone.
[Time Frame: 6 months]
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Secondary ID(s)
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CSCR 104/2014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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