Working… Menu

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. Identifier: NCT00211393
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : October 25, 2012
LuEsther T. Mertz Retinal Research Center
Information provided by (Responsible Party):
Joan, Manhattan Eye, Ear & Throat Hospital

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).

Condition or disease Intervention/treatment Phase
Chronic Central Serous Chorioretinopathy Drug: ketoconazole Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of The Treatment of Central Serous Chorioretinopathy With Ketoconazole.
Study Start Date : May 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Drug: ketoconazole

Drug: ketoconazole

Other Names:


600mg. /day for 6 weeks


Drug: ketoconazole
600mg. /day for 6 weeks

Primary Outcome Measures :
  1. Visual acuity (ETDRS) after 6 weeks of treatment [ Time Frame: 18 weeks ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00211393

Layout table for location information
United States, New York
Manhattan Eye, Ear & Throat Hospital
New York, New York, United States, 10021
Sponsors and Collaborators
Manhattan Eye, Ear & Throat Hospital
LuEsther T. Mertz Retinal Research Center
Layout table for investigator information
Principal Investigator: K. Bailey Freund, MD Manhattan Eye, Ear & Throat Hospital
Layout table for additonal information
Responsible Party: Joan, K. Bailey Freund, M.D., Manhattan Eye, Ear & Throat Hospital Identifier: NCT00211393    
Other Study ID Numbers: M00.013
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 25, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
Layout table for MeSH terms
Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors