Effect of Spironolactone in Treating Chronic Non-resolutive Central Serous Chorioretinitis
Recruitment status was Recruiting
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
Central Serous Chorioretinitis
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Evaluation de la Spironolactone Dans le Traitement Des choriorétinites séreuses Centrales Non résolutives à Trois Mois|
- Change in Central macular thickness [ Time Frame: 1 and 3 months ] [ Designated as safety issue: No ]Sub retinal fluid decrease > or = 40 microns
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||January 2013|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
25mg tablet once a day for 1 month
Other Name: aldactone
Placebo Comparator: Placebo
one tablet once a day for 1 month
This is a prospective placebo controlled cross over study including 16 patients
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552044
|Contact: Francine Behar-Cohen, MD, PhD||01 40 46 78 firstname.lastname@example.org|
|Hotel-Dieu of Paris||Recruiting|
|Paris, France, 75004|
|Contact: Francine Behar-Cohen, MD,PhD 01 40 46 78 40|
|Principal Investigator: Francine Behar-Cohen, MD,PhD|