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A Pilot Study of the Treatment of Central Serous Chorioretinopathy With Ketoconazole (CSC/Keto)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00211393
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : October 25, 2012
Sponsor:
Collaborator:
LuEsther T. Mertz Retinal Research Center
Information provided by (Responsible Party):
Joan, Manhattan Eye, Ear & Throat Hospital

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 21, 2005
Last Update Posted Date October 25, 2012
Study Start Date  ICMJE May 2005
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2007)
Visual acuity (ETDRS) after 6 weeks of treatment [ Time Frame: 18 weeks ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2007)
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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study of the Treatment of Central Serous Chorioretinopathy With Ketoconazole
Official Title  ICMJE A Pilot Study of The Treatment of Central Serous Chorioretinopathy With Ketoconazole.
Brief Summary 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).
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Central Serous Chorioretinopathy
Intervention  ICMJE Drug: ketoconazole
600mg. /day for 6 weeks
Study Arms  ICMJE Experimental: Drug: ketoconazole

Drug: ketoconazole

Other Names:

ketoconazole

600mg. /day for 6 weeks

--------------------------------------------------------------------------------

Intervention: Drug: ketoconazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2009)
5
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age less than 60 years
  2. 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).
  3. Be able to return for all study visits for 3 months' duration.
  4. Be able to provide written informed consent
  5. Must have sufficiently clear media to allow for adequate fundus photography

Exclusion Criteria:

  1. Have choroidal neovascularization.
  2. Have any evidence of clinically significant intraocular inflammation, angioid streaks, presumed ocular histoplasmosis syndrome, or other precursor of choroidal neovascularization.
  3. Have additional eye disease that compromises the visual acuity of the study eye.
  4. Are receiving any systemic steroid therapy
  5. Have any significant medical history
  6. Have a history of severe hypersensitivity reaction to any of the dyes or the drug used in the study.
  7. Have any history of ocular conditions that may mimic CSC
  8. Are pregnant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00211393
Other Study ID Numbers  ICMJE M00.013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joan, Manhattan Eye, Ear & Throat Hospital
Study Sponsor  ICMJE Manhattan Eye, Ear & Throat Hospital
Collaborators  ICMJE LuEsther T. Mertz Retinal Research Center
Investigators  ICMJE
Principal Investigator: K. Bailey Freund, MD Manhattan Eye, Ear & Throat Hospital
PRS Account Manhattan Eye, Ear & Throat Hospital
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP