Clinical trial NCT00211393: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Central Serous Chorioretinopathy
Lead sponsor: Manhattan Eye, Ear & Throat Hospital
Sponsor class: OTHER
Collaborators: name: LuEsther T. Mertz Retinal Research Center
First posted: 2005-09-21
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual acuity (ETDRS) after 6 weeks of treatment
timeFrame: 18 weeks
Secondary outcomes:
measure: Changes in the choroidal vascular pattern as observed on FA and changes at the posterior pole as measured with optical coherence tomography
timeFrame: 18 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Manhattan Eye, Ear & Throat Hospital
state: New York
Study officials:
affiliation: Manhattan Eye, Ear & Throat Hospital
name: K. Bailey Freund, MD
role: PRINCIPAL_INVESTIGATOR
References: