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OpenTrials
Completed

NCT Number: NCT00211393

A Pilot Study of the Treatment of Central Serous Chorioretinopathy With Ketoconazole

The purpose of this study is to determine the effect of an adrenocorticoid antagonist (ketoconazole), 600 mg per day for 4 weeks, in the treatment of patients with central serous chorioretinopathy (CSC).

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Manhattan Eye, Ear & Throat Hospital

New York, 10021, United States

About this study

A complete ophthalmic evaluation and tests: autofluorescence and Fluorescein angiography, Color Fundus Photography, OCT, including liver and adrenal functions and pregnancy test, if applicable will be done on the screening visit. If the patient is eligible, the patient will be started on ketoconazole 600 mg per day by mouth for the following next 6 weeks. The patient will be rechecked at weeks 5-6, 10,14 and 18. During all these visits a complete ophthalmic examination autofluorescence, OCT, and color fundus photographs will be done.

Repeat Liver and Adrenal function tests will be done at weeks 5-6 and 10 visits.

On the exit visit, all the ophthalmic tests and procedures on the baseline visit will be done. Adverse events, and concomitant medications and treatments will be reported on all visits.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age less than 60 years
  • Must have clinical signs of CSC with leakage from the level of the RPE during fluorescein angiography and neurosensory detachment documented by optical coherence tomography (OCT).
  • Be able to return for all study visits for 3 months' duration.
  • Be able to provide written informed consent
  • Must have sufficiently clear media to allow for adequate fundus photography

Exclusion criteria

  • Have choroidal neovascularization.
  • Have any evidence of clinically significant intraocular inflammation, angioid streaks, presumed ocular histoplasmosis syndrome, or other precursor of choroidal neovascularization.
  • Have additional eye disease that compromises the visual acuity of the study eye.
  • Are receiving any systemic steroid therapy
  • Have any significant medical history
  • Have a history of severe hypersensitivity reaction to any of the dyes or the drug used in the study.
  • Have any history of ocular conditions that may mimic CSC
  • Are pregnant

Treatment and study plan

Ketoconazole

Drug

600mg. /day for 6 weeks

Primary outcomes

  1. Visual acuity (ETDRS) after 6 weeks of treatment

    Time frame: 18 weeks

Secondary outcomes

  1. Changes in the choroidal vascular pattern as observed on FA and changes at the posterior pole as measured with optical coherence tomography

    Time frame: 18 weeks

Sponsors and collaborators

Lead sponsor

Manhattan Eye, Ear & Throat Hospital

Other

Collaborators

  • LuEsther T. Mertz Retinal Research Center

Registry information

Official study title

A Pilot Study of The Treatment of Central Serous Chorioretinopathy With Ketoconazole.

Acronym: CSC/Keto

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 21, 2005
Registry last updated
Oct 25, 2012

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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