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Central Serous ChorioretinopathyPhase 2NCT02153125

Eplerenone For the Treatment of Chronic Central Serous Chorioretinopathy

A Phase 2 study testing Eplerenone in people with Central Serous Chorioretinopathy, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Central Serous Chorioretinopathy
What is being tested?
Eplerenone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteIsrael
Study dates
Apr 2014to Jun 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Other retinal disease
  • Choroidal neovascularization
  • Diabetes
  • A history of uveitis
  • Ocular surgery in the prior 3 months
  • Allergy to fluorescein or indocyanine green
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Michaella Goldstein, MD contact

97236974361

michgold@netvision.net.il

Israel1 site, 1 recruiting

  • Tel Aviv Souraski Medical Center

    Tel Aviv, Israel, 64239

    Michaella Goldstein, MD

    Roy Schwartz, MD

    Recruiting

Other trials in Israel

About this study

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

Read the detailed description
  • The goal of the study is to examine the short-term effects and safety of eplerenone, a systemic anti-aldosterone medication, in a group of patients with central serous chorioretinopathy (CSCR).
  • There is currently no standard treatment or therapy for chronic CSCR, a potentially debilitating eye disease.
  • There is evidence that high blood serum corticosteroid levels can cause or worsen CSCR
  • Eplerenone, a mineralocorticoid receptor antagonist, has been shown to be of visual and anatomic benefit in a small series of 4 patients with chronic CSCR, suggesting that decreasing mineralocorticoid action in the eye may improve signs and symptoms of CSCR
  • The study's aim is to evaluate a standardized dose of eplerenone in a controlled prospective fashion for chronic CSCR.
  • The study consists of taking a standard dose of eplerenone, 25mg once daily for a week, followed by 50mg once daily, for a total of 3 months
  • Patients will be monitored for efficacy and side effects from the beginning of treatment and for 6 months
Being tested
Eplerenone
Medical subject headings
Central Serous Chorioretinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EplerenoneDrug

Study groups in NCT02153125
Study groupRoleWhat they receive
EplerenoneExperimental25mg eplerenone given daily for a week, followed by 50mg given for a total of 3 months since commencement of treatment
Receives: Drug: Eplerenone
PlaceboPlacebo comparatorNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionJun 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02153125
Sponsor's protocol ID
0405-13-TLV
Status last verified
May 2014
First submitted
29 May 2014
Last updated
2 Jun 2014
Results posted
No

Publications

  • 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.

    PubMed 22684104

  • 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.

    PubMed 20930852

  • 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.

    PubMed 18538401

  • 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.

    PubMed 19896635

  • 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.

    PubMed 6682293

  • 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.

    PubMed 40522203

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Eplerenone in people with Central Serous Chorioretinopathy, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Michaella Goldstein, MD (97236974361, michgold@netvision.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decrease of at least 10% in subretinal fluid thickness as measured by optical coherence tomography (OCT) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02153125, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2014.

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