- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00211393
A Pilot Study of the Treatment of Central Serous Chorioretinopathy With Ketoconazole (CSC/Keto)
A Pilot Study of The Treatment of Central Serous Chorioretinopathy With Ketoconazole.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Manhattan Eye, Ear & Throat Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Drug: ketoconazole
Drug: ketoconazole Other Names: ketoconazole 600mg. /day for 6 weeks -------------------------------------------------------------------------------- |
600mg. /day for 6 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual acuity (ETDRS) after 6 weeks of treatment
Time Frame: 18 weeks
|
18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
18 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: K. Bailey Freund, MD, Manhattan Eye, Ear & Throat Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Retinal Diseases
- Central Serous Chorioretinopathy
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Ketoconazole
Other Study ID Numbers
- M00.013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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