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

NCT01552044 | Completed Phase 1 DMC

• 2 other identifiers: C11-212011-003046-40
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Conditions

Central Serous Chorioretinitis

Keywords

retina

Outcome Measures

Primary Outcomes (1)

• Change in Central macular thickness

  Sub retinal fluid decrease \> or = 40 microns

  1 and 3 months

Study Arms (2)

spironolactone

EXPERIMENTAL

Spironolactone 25mg/day

Drug: Spironolactone

Placebo

PLACEBO COMPARATOR

placebo tablets

Drug: Placebo

Interventions

Spironolactone DRUG

25mg tablet once a day for 1 month

Also known as: aldactone

spironolactone

Placebo DRUG

one tablet once a day for 1 month

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Hotel-Dieu of Paris

Paris, 75004, France

Location

Related Publications (2)

• Bousquet E, Beydoun T, Rothschild PR, Bergin C, Zhao M, Batista R, Brandely ML, Couraud B, Farman N, Gaudric A, Chast F, Behar-Cohen F. SPIRONOLACTONE FOR NONRESOLVING CENTRAL SEROUS CHORIORETINOPATHY: A RANDOMIZED CONTROLLED CROSSOVER STUDY. Retina. 2015 Dec;35(12):2505-15. doi: 10.1097/IAE.0000000000000614.

  PMID: 26017871 BACKGROUND

• Lange CA, Qureshi R, Pauleikhoff L. Interventions for central serous chorioretinopathy: a network meta-analysis. Cochrane Database Syst Rev. 2025 Jun 16;6(6):CD011841. doi: 10.1002/14651858.CD011841.pub3.

  PMID: 40522203 DERIVED

MeSH Terms

Interventions

Spironolactone

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2012
• First Posted: March 13, 2012
• Study Start: January 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2013
• Last Updated: August 27, 2025

Record last verified: 2016-02

Locations

FR (1)