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Completed

NCT Number: NCT01990677

Eplerenone for the Treatment of Central Serous Chorioretinopathy

To test the effect oral eplerenone versus placebo in patients with central serious chorioretinopathy .

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mid Atlantic Retina, Cherry Hill, New Jersey, United States

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About this study

To evaluate the effect of oral eplerenone compared to placebo in patients with central serous chorioretinopathy (CSCR) on sub-foveal (small part of retina) fluid using optical coherence tomography (OCT).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 and over
  • Ability to give written informed consent
  • Sub-retinal fluid under fovea seen on OCT
  • Diagnosis of central serous chorioretinopathy (CSCR): classification is at the discretion of the investigator, but general guidelines are
  • Acute- first episode or symptoms less than one month prior to presentation
  • Chronic- previously documented sub-foveal fluid, any prior treatment, symptoms for over 3 months, or <50% reduction in fluid thickness on OCT after 3 months.

Exclusion criteria

  • Age under 18
  • Impaired decision-making ability
  • At initial laboratory screening serum potassium >5.5 milliequivalent (mEq)/L
  • At initial laboratory screening serum creatinine >2 mg/dL in men and >1.8 mg/dL in women or decreased renal function by creatinine clearance less than 50 mL/min
  • Absence of sub-foveal fluid
  • Any patient with prior treatment for CSCR within 3 months of enrollment
  • Patients taking potassium supplements or potassium-sparing diuretics spironolactone, amiloride, and triamterene and/or potent CYP3A4 (cytochrome) inhibitors (amifostine, cyclosporine, fluconazole, itraconazole, ketoconazole, mifepristone, posaconazole, potassium salts, rituximab, tacrolimus, voriconazole nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir)
  • Women who are pregnant or are actively trying to conceive
  • Patients with type 1 or type 2 diabetes

Treatment and study plan

25mg Eplerenone

Drug

Patients will be given 25mg Eplerenone (or 50mg Eplerenone) or placebo throughout the study and the dosage will be based on the serum potassium/creatine levels. Patients will be randomized 2:1 such that 36 patients in each group will receive eplerenone and 16 patients in each group will receive placebo

Other names: Eplerenone, Inspra

Placebo

Drug

Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo.

Other names: Sugar pill

Primary outcomes

  1. Mean Change in Maximal Subretinal Fluid Height Based on Spectral Domain Optical Coherence Tomography (OCT) Measurement.

    Time frame: Baseline and 2 months

    Mean change in maximal subretinal fluid height based on spectral domain OCT from baseline to month 2 in chronic central serous chorioretinopathy (CSCR) patients receiving placebo versus eplerenone.

Secondary outcomes

  1. Mean Change in Subfoveal Fluid Height Based on OCT Measurement

    Time frame: Baseline and Month 2

    Mean change in subfoveal fluid height based on spectral domain OCT measurement from baseline to month 2 in chronic CSCR patients receiving placebo versus eplerenone.

Other outcomes

  1. Proportion of Eyes Demonstrating a Reduction in Subretinal Fluid on OCT

    Time frame: Baseline and Month 2

    Proportion of eyes having a decrease in subretinal fluid on spectral domain OCT from baseline to month 2 in chronic CSCR patients receiving placebo versus eplerenone.

Sponsors and collaborators

Lead sponsor

Wills Eye

Other

Collaborators

  • Mid Atlantic Retina

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 21, 2013
Registry last updated
Nov 7, 2018

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.

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