NCT02153125

Brief Summary

The aim of the study is to determine the efficacy and safety in treating patients with chronic central serous chorioretinopathy with the drug eplerenone.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Last Updated

June 2, 2014

Status Verified

May 1, 2014

Enrollment Period

1.2 years

First QC Date

May 29, 2014

Last Update Submit

May 30, 2014

Conditions

Central Serous Chorioretinopathy

Outcome Measures

Primary Outcomes (1)

  • Decrease of at least 10% in subretinal fluid thickness as measured by optical coherence tomography (OCT)

    6 months

Study Arms (2)

Eplerenone

EXPERIMENTAL

25mg eplerenone given daily for a week, followed by 50mg given for a total of 3 months since commencement of treatment

Drug: Eplerenone

Placebo

PLACEBO COMPARATOR

Interventions

EplerenoneDRUG
Eplerenone

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic central serous chorioretinopathy (CSCR): Previous diagnosis of CSCR, persistent subretinal fluid on OCT for more than 4 months after initial presentation to the eye clinic

You may not qualify if:

  • Other retinal disease
  • Choroidal neovascularization
  • Diabetes
  • A history of uveitis
  • Ocular surgery in the prior 3 months
  • Allergy to fluorescein or indocyanine green
  • Pregnancy, lactation or female patients in fertility age not treated with contraceptive pills
  • Creatinine clearance \< 50 ml/min
  • Hyperkalemia \> 5 mmol/l
  • Patients treated with drugs deactivated by cytochrome P450 3A4 (CYP3A4)
  • Serum creatinine \> 2 mg/dl in men or \> 1.8 mg/dl in women
  • Treatment with potassium sparing agents or potassium
  • Treatment with Angiotensin converting enzyme (ACE)/angiotensin II receptor blocker (ARB) inhibitors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Souraski Medical Center

Tel Aviv, Israel, 64239, Israel

RECRUITING

Related Publications (6)

  • Zhao M, Celerier I, Bousquet E, Jeanny JC, Jonet L, Savoldelli M, Offret O, Curan A, Farman N, Jaisser F, Behar-Cohen F. Mineralocorticoid receptor is involved in rat and human ocular chorioretinopathy. J Clin Invest. 2012 Jul;122(7):2672-9. doi: 10.1172/JCI61427. Epub 2012 Jun 11.

    PMID: 22684104BACKGROUND

  • Gemenetzi M, De Salvo G, Lotery AJ. Central serous chorioretinopathy: an update on pathogenesis and treatment. Eye (Lond). 2010 Dec;24(12):1743-56. doi: 10.1038/eye.2010.130. Epub 2010 Oct 8.

    PMID: 20930852BACKGROUND

  • Chan WM, Lai TY, Lai RY, Liu DT, Lam DS. Half-dose verteporfin photodynamic therapy for acute central serous chorioretinopathy: one-year results of a randomized controlled trial. Ophthalmology. 2008 Oct;115(10):1756-65. doi: 10.1016/j.ophtha.2008.04.014. Epub 2008 Jun 5.

    PMID: 18538401BACKGROUND

  • Reibaldi M, Cardascia N, Longo A, Furino C, Avitabile T, Faro S, Sanfilippo M, Russo A, Uva MG, Munno F, Cannemi V, Zagari M, Boscia F. Standard-fluence versus low-fluence photodynamic therapy in chronic central serous chorioretinopathy: a nonrandomized clinical trial. Am J Ophthalmol. 2010 Feb;149(2):307-315.e2. doi: 10.1016/j.ajo.2009.08.026. Epub 2009 Nov 6.

    PMID: 19896635BACKGROUND

  • Robertson DM, Ilstrup D. Direct, indirect, and sham laser photocoagulation in the management of central serous chorioretinopathy. Am J Ophthalmol. 1983 Apr;95(4):457-66. doi: 10.1016/0002-9394(83)90265-9.

    PMID: 6682293BACKGROUND

  • 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: 40522203DERIVED

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Michaella Goldstein, MD

CONTACT

97236974361michgold@netvision.net.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Head Department of Ophthalmology

Study Record Dates

First Submitted

May 29, 2014

First Posted

June 2, 2014

Study Start

April 1, 2014

Primary Completion

June 1, 2015

Last Updated

June 2, 2014

Record last verified: 2014-05

Locations

IL(1)