A Pilot Study of the Treatment of Central Serous Chorioretinopathy With Ketoconazole - Full Text View

Sponsor:	Manhattan Eye, Ear & Throat Hospital
Collaborator:	LuEsther T. Mertz Retinal Research Center
Information provided by:	Manhattan Eye, Ear & Throat Hospital
ClinicalTrials.gov Identifier:	NCT00211393

Purpose

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	Intervention	Phase
Chronic Central Serous Chorioretinopathy	Drug: ketoconazole	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Pilot Study of The Treatment of Central Serous Chorioretinopathy With Ketoconazole.

Resource links provided by NLM:

Drug Information available for: Ketoconazole Fungarest

U.S. FDA Resources

Further study details as provided by Manhattan Eye, Ear & Throat Hospital:

Primary Outcome Measures:

Visual acuity (ETDRS) after 6 weeks of treatment [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Enrollment:	5
Study Start Date:	May 2005
Study Completion Date:	April 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Intervention Details:

600mg. /day for 6 weeks

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211393

Locations

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

Investigators

Principal Investigator:

K. Bailey Freund, MD

Manhattan Eye, Ear & Throat Hospital

More Information

No publications provided

Responsible Party:	LuEsther T. Mertz Retinal Research Center ( Joan Daly,RN )
Study ID Numbers:	M00.013
Study First Received:	September 13, 2005
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00211393 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Antifungal Agents
Ketoconazole
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010