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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01552044
First received: February 14, 2012
Last updated: March 8, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Central Serous Chorioretinitis
Drug: Spironolactone
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation de la Spironolactone Dans le Traitement Des choriorétinites séreuses Centrales Non résolutives à Trois Mois

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • Change in Central macular thickness [ Time Frame: 1 and 3 months ] [ Designated as safety issue: No ]
    Sub retinal fluid decrease > or = 40 microns


Estimated Enrollment: 16
Study Start Date: January 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: spironolactone
Spironolactone 25mg/day
Drug: Spironolactone
25mg tablet once a day for 1 month
Other Name: aldactone
Placebo Comparator: Placebo
placebo tablets
Drug: Placebo
one tablet once a day for 1 month

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552044

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

Locations
France
Hotel-Dieu of Paris Recruiting
Paris, France, 75004
Contact: Francine Behar-Cohen, MD,PhD    01 40 46 78 40      
Principal Investigator: Francine Behar-Cohen, MD,PhD         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
  More Information

No publications provided

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01552044     History of Changes
Other Study ID Numbers: C11-21, 2011-003046-40
Study First Received: February 14, 2012
Last Updated: March 8, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
retina

Additional relevant MeSH terms:
Chorioretinitis
Uveitis
Retinitis
Retinal Diseases
Eye Diseases
Choroiditis
Choroid Diseases
Uveal Diseases
Uveitis, Posterior
Panuveitis
Spironolactone
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014