NCT01552044

Effect of Spironolactone in Treating Chronic Non-resolutive Central Serous Chorioretinitis

Evaluation de la Spironolactone Dans le Traitement Des choriorétinites séreuses Centrales Non résolutives à Trois Mois

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Conditions

• Central Serous Chorioretinitis

Interventions

Type	Name	Description
DRUG	Spironolactone	25mg tablet once a day for 1 month
DRUG	Placebo	one tablet once a day for 1 month

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-01-01
• Completion: 2013-02-01
• First posted: 2012-03-13
• Last updated: 2025-08-27

Locations

1 site across 1 country: France