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

Study Overview
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Brief Summary
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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
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This is a prospective placebo controlled cross over study including 16 patients

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

Conditions
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Central Serous Chorioretinitis

Intervention / Treatment
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* Drug: Spironolactone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: spironolactone<br>Spironolactone 25mg/day | Drug: Spironolactone<br>* 25mg tablet once a day for 1 month<br>* Other names: aldactone;|
| Placebo Comparator: Placebo<br>placebo tablets | Drug: Placebo<br>* one tablet once a day for 1 month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Central macular thickness | Sub retinal fluid decrease > or = 40 microns | 1 and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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retina