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

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

Tracking Information

• First Submitted Date: September 13, 2005
• First Posted Date: September 21, 2005
• Last Update Posted Date: October 25, 2012
• Study Start Date: May 2005
• Actual Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 4, 2007): Visual acuity (ETDRS) after 6 weeks of treatment [ Time Frame: 18 weeks ]
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Pilot Study of the Treatment of Central Serous Chorioretinopathy With Ketoconazole
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Chronic Central Serous Chorioretinopathy

Intervention

Drug: ketoconazole

600mg. /day for 6 weeks

Study Arms

Experimental: Drug: ketoconazole

Drug: ketoconazole

Other Names:

ketoconazole

600mg. /day for 6 weeks

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

Intervention: Drug: ketoconazole

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 3, 2009): 5
• Original Enrollment: Not Provided
• Actual Study Completion Date: April 2008
• Actual Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00211393
• Other Study ID Numbers: M00.013
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Joan, Manhattan Eye, Ear & Throat Hospital
• Study Sponsor: Manhattan Eye, Ear & Throat Hospital
• Collaborators: LuEsther T. Mertz Retinal Research Center

Investigators

• Principal Investigator: K. Bailey Freund, MD; Manhattan Eye, Ear & Throat Hospital

• PRS Account: Manhattan Eye, Ear & Throat Hospital
• Verification Date: October 2012