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

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Treatments: Spironolactone

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