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

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ClinicalTrials.gov Identifier: NCT01552044
Recruitment Status : Completed
First Posted : March 13, 2012
Last Update Posted : February 25, 2016
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Central Serous Chorioretinitis Drug: Spironolactone Drug: Placebo Phase 1 Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation de la Spironolactone Dans le Traitement Des choriorétinites séreuses Centrales Non résolutives à Trois Mois
Study Start Date : January 2012
Primary Completion Date : January 2013
Study Completion Date : February 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in Central macular thickness [ Time Frame: 1 and 3 months ]
    Sub retinal fluid decrease > or = 40 microns

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01552044

Hotel-Dieu of Paris
Paris, France, 75004
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

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 ( EudraCT Number )
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016

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

Additional relevant MeSH terms:
Retinal Diseases
Eye Diseases
Choroid Diseases
Uveal Diseases
Uveitis, Posterior
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents