Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211393
Status:
COMPLETED
Last Update Posted:
2012-10-25
First Post:
2005-09-13
Brief Title:
A Pilot Study of the Treatment of Central Serous Chorioretinopathy With Ketoconazole
Sponsor:
Manhattan Eye Ear Throat Hospital
Organization:
Manhattan Eye Ear Throat Hospital
Study Overview
Official Title:
A Pilot Study of The Treatment of Central Serous Chorioretinopathy With Ketoconazole
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CSCKeto
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 1014 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None