Effect of Spironolactone in Treating Chronic Non-resolutive Central Serous Chorioretinitis
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|ClinicalTrials.gov Identifier: NCT01552044|
Recruitment Status : Completed
First Posted : March 13, 2012
Last Update Posted : February 25, 2016
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
|Condition or disease||Intervention/treatment||Phase|
|Central Serous Chorioretinitis||Drug: Spironolactone Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Evaluation de la Spironolactone Dans le Traitement Des choriorétinites séreuses Centrales Non résolutives à Trois Mois|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||February 2013|
25mg tablet once a day for 1 month
Other Name: aldactone
Placebo Comparator: Placebo
one tablet once a day for 1 month
- Change in Central macular thickness [ Time Frame: 1 and 3 months ]Sub retinal fluid decrease > or = 40 microns
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01552044
|Hotel-Dieu of Paris|
|Paris, France, 75004|