Effect of Spironolactone in Treating Chronic Non-resolutive Central Serous Chorioretinitis
Primary Purpose
Central Serous Chorioretinitis
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Spironolactone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Central Serous Chorioretinitis focused on measuring retina
Eligibility Criteria
Inclusion Criteria:
- Patient between 18 and 60 years
- CSCR affecting the macula and non-resolutive for at least 3 months
- Patients having given and signed informed consent
- Vital prognosis non engaged for the next 6 months.
Exclusion Criteria:
- Other ocular pathology
- Neovascularization,
- Diabetes
- Uveitis
- Ocular surgery in the last 3 months
- Allergy to fluorescein or indocyanine green
- Pregnancy or no contraception
- Renal or liver insufficiency
- Kaliemia ≥ 5.5 mmol/l Criteria of efficacy
Sites / Locations
- Hotel-Dieu of Paris
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
spironolactone
Placebo
Arm Description
Spironolactone 25mg/day
placebo tablets
Outcomes
Primary Outcome Measures
Change in Central macular thickness
Sub retinal fluid decrease > or = 40 microns
Secondary Outcome Measures
Full Information
NCT ID
NCT01552044
First Posted
February 14, 2012
Last Updated
February 24, 2016
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT01552044
Brief Title
Effect of Spironolactone in Treating Chronic Non-resolutive Central Serous Chorioretinitis
Official Title
Evaluation de la Spironolactone Dans le Traitement Des choriorétinites séreuses Centrales Non résolutives à Trois Mois
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of the study is to evaluate the effect of spironolactone on 16 patients presenting with chronic non-resolutive central serous chorioretinitis (CSCR) and to evaluate whether spironolactone can resolve sub retinal fluid in these patients.
CSCR is a major cause of visual loss in the young population. It is characterized by sub retinal fluid under the retina and retinal pigment epithelial detachments. The exact causes of the disease remain unknown but a choroidopathy has been suggested. Moreover, corticotherapy and stress are known risk factors of CSCR.
Our preclinical studies have demonstrated that the mineralocorticoid pathway could be involved in the control of choroidal blood flow.
The investigators propose to evaluate the mineralocorticoid receptors antagonist spironolactone in the treatment of CSCR.
Criteria of efficacy Endpoint: reduction of subretinal fluid ≥ 40 microns Secondary endpoint: visual acuity gain ≥ 15 EDTRS letters
Detailed Description
This is a prospective placebo controlled cross over study including 16 patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Serous Chorioretinitis
Keywords
retina
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
spironolactone
Arm Type
Experimental
Arm Description
Spironolactone 25mg/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo tablets
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Other Intervention Name(s)
aldactone
Intervention Description
25mg tablet once a day for 1 month
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
one tablet once a day for 1 month
Primary Outcome Measure Information:
Title
Change in Central macular thickness
Description
Sub retinal fluid decrease > or = 40 microns
Time Frame
1 and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient between 18 and 60 years
CSCR affecting the macula and non-resolutive for at least 3 months
Patients having given and signed informed consent
Vital prognosis non engaged for the next 6 months.
Exclusion Criteria:
Other ocular pathology
Neovascularization,
Diabetes
Uveitis
Ocular surgery in the last 3 months
Allergy to fluorescein or indocyanine green
Pregnancy or no contraception
Renal or liver insufficiency
Kaliemia ≥ 5.5 mmol/l Criteria of efficacy
Facility Information:
Facility Name
Hotel-Dieu of Paris
City
Paris
ZIP/Postal Code
75004
Country
France
12. IPD Sharing Statement
Learn more about this trial
Effect of Spironolactone in Treating Chronic Non-resolutive Central Serous Chorioretinitis
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