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

Information source: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Central Serous Chorioretinitis

Intervention: Spironolactone (Drug); Placebo (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Institut National de la Santé Et de la Recherche Médicale, France

Overall contact:
Francine Behar-Cohen, MD, PhD, Phone: 01 40 46 78 40, Email: francine.behar@gmail.com

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in Central macular thickness

Detailed description: This is a prospective placebo controlled cross over study including 16 patients

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

Francine Behar-Cohen, MD, PhD, Phone: 01 40 46 78 40, Email: francine.behar@gmail.com

Hotel-Dieu of Paris, Paris 75004, France; Recruiting
Francine Behar-Cohen, MD,PhD, Phone: 01 40 46 78 40
Francine Behar-Cohen, MD,PhD, Principal Investigator
Additional Information

Starting date: January 2012
Last updated: March 8, 2012

Page last updated: August 23, 2015

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