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

Phase 1

Completed

• Conditions: Central Serous Chorioretinitis
• Interventions: Drug: Placebo; Drug: Spironolactone

• Registration Number: NCT01552044
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Brief 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

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-14
• Study First Submitted QC: 2012-03-08
• Study First Posted: 2012-03-13
• Primary Completion: 2013-01
• Study Completion: 2013-02
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-24
• Last Update Posted: 2016-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo tablets
spironolactone	Spironolactone	Spironolactone 25mg/day

Primary Outcome Measures

Name	Time	Method
Change in Central macular thickness	1 and 3 months	Sub retinal fluid decrease \> or = 40 microns

Trial Locations

Locations (1)

Hotel-Dieu of Paris; 🇫🇷 Paris, France