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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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19 February 2015 |
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Main ID: |
NCT02215330 |
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Date of registration:
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11/08/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of the Beneficial Effects of Eplerenone on Central Serous Chorioretinopathy
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Scientific title:
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A Randomized, Double-masked, Placebo Controlled Study of the Beneficial Effects of Eplerenone on Central Serous Chorioretinopathy |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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60 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02215330 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Austria
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Contacts
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Name:
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Oliver Findl, MD, Prof, MBA |
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Address:
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Telephone:
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Email:
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Affiliation:
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VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Vienna, Vienna, Austria 1140 |
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Name:
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Oliver Findl, MD, Prof, MBA |
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Address:
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Telephone:
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0043191021 |
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Email:
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ofindl@googlemail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients suffering from untreated CSC for less than two months
- Age 21 and older
- Written informed consent
Exclusion Criteria:
- Patients who have recently been treated with eplerenone
- Pregnancy or patients who are currently breast-feeding
- Patients who should not use eplerenone for any reason - an extensive internal
medicine assessment will be performed in all patients prior to treatment start)
Age minimum:
21 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Central Serous Chorioretinopathy
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Intervention(s)
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Drug: Eplerenone
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Drug: Maltodextrin
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Primary Outcome(s)
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Difference in the number of successful treatments after 16 weeks, defined as complete absence of subretinal fluid on SD-OCT
[Time Frame: 16 weeks]
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Secondary Outcome(s)
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Changes in retinal thickness between eplerenone and placebo.
[Time Frame: 16 weeks]
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Changes in retinal volume between eplerenone and placebo.
[Time Frame: 16 weeks]
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Changes in visual acuity between eplerenone and placebo.
[Time Frame: 16 weeks]
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Secondary ID(s)
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EPL
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EK_14_170_0814
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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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