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Completed

NCT Number: NCT02462499

Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population

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

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Key information

Conditions

Chronic Central Serous Chorioretinopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Semmelweis University, Department of Ophthalmology

Budapest, 1085, Hungary

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chronic central serous chorioretinopathy (CSCR) with persistent subretinal fluid on OCT for more than 3 months after initial presentation .
  • Written informed consent

Exclusion criteria

  • Persons with impaired decision-making ability.
  • Pregnant women or who are actively trying to conceive.
  • Additional eye disease affecting the macula or posterior retina.
  • Creatinine clearance < 50 ml/min
  • Hyperkalemia > 5 mmol/l
  • Serum creatinine > 2 mg/dl in men or > 1.8 mg/dl in women
  • Treatment with potassium sparing agents or potassium
  • Treatment with any other drugs known to cause interaction with eplerenone
  • Microalbuminuria in patients with type 2 diabetes

Treatment and study plan

Inspra (eplerenone)

Drug

Primary outcomes

  1. Resolution of sub-retinal fluid measured by optical coherence tomography (OCT).

    Time frame: 6 months

  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability.

    Time frame: 3 months

Secondary outcomes

  1. Changes in macular volume at baseline, during and after the treatment with eplerenone.

    Time frame: 6 months

  2. Changes in visual acuity at baseline measured on Early Treatment of Diabetic Retinopathy Study (ETDRS) chart, during and after the treatment with eplerenone.

    Time frame: 6 months

  3. Changes in choroideal thickness at baseline measured by OCT, during and after the treatment with eplerenone in both eyes.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 4, 2015
Registry last updated
Oct 18, 2016

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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