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Completed

NCT Number: NCT01552044

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

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

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Key information

Conditions

Central Serous Chorioretinitis

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hotel-Dieu of Paris

Paris, 75004, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spironolactone

Drug

25mg tablet once a day for 1 month

Other names: aldactone

Placebo

Drug

one tablet once a day for 1 month

Primary outcomes

  1. Change in Central macular thickness

    Time frame: 1 and 3 months

    Sub retinal fluid decrease > or = 40 microns

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 13, 2012
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.