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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

February 14, 2012
March 8, 2012
January 2012
January 2013   (final data collection date for primary outcome measure)
Change in Central macular thickness [ Time Frame: 1 and 3 months ] [ Designated as safety issue: No ]
Sub retinal fluid decrease > or = 40 microns
Same as current
Complete list of historical versions of study NCT01552044 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Spironolactone in Treating Chronic Non-resolutive Central Serous Chorioretinitis
Evaluation de la Spironolactone Dans le Traitement Des choriorétinites séreuses Centrales Non résolutives à Trois Mois

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

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

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Central Serous Chorioretinitis
  • Drug: Spironolactone
    25mg tablet once a day for 1 month
    Other Name: aldactone
  • Drug: Placebo
    one tablet once a day for 1 month
  • Experimental: spironolactone
    Spironolactone 25mg/day
    Intervention: Drug: Spironolactone
  • Placebo Comparator: Placebo
    placebo tablets
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
16
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Francine Behar-Cohen, MD, PhD 01 40 46 78 40 francine.behar@gmail.com
France
 
NCT01552044
C11-21, 2011-003046-40
Yes
Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Santé Et de la Recherche Médicale, France
Not Provided
Not Provided
Institut National de la Santé Et de la Recherche Médicale, France
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP