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

This study has been completed.
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France Identifier:
First received: February 14, 2012
Last updated: February 24, 2016
Last verified: February 2016

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
Intervention Model: Crossover Assignment
Masking: Double Blind (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

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 ]
    Sub retinal fluid decrease > or = 40 microns

Enrollment: 17
Study Start Date: January 2012
Study Completion Date: February 2013
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

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
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Please refer to this study by its identifier: NCT01552044

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

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France Identifier: NCT01552044     History of Changes
Other Study ID Numbers: C11-21
2011-003046-40 ( EudraCT Number )
Study First Received: February 14, 2012
Last Updated: February 24, 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 processed this record on May 25, 2017