PDE5 Inhibitor Use and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
NCT ID: NCT00867815
Last Updated: 2019-01-23
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
10 participants
INTERVENTIONAL
2009-07-13
2018-03-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Arm 1
Diagnostic procedures
The patients will not receive any study drug in this study. The patients will have ophthalmological (eye) examinations, blood work and will complete an interview
Interventions
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Diagnostic procedures
The patients will not receive any study drug in this study. The patients will have ophthalmological (eye) examinations, blood work and will complete an interview
Eligibility Criteria
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Inclusion Criteria
* NAION onset definable by the subject within a 2 calendar day window
* Men who have taken at least 1 dose of PDE5 inhibitor(s) at any time in the 1 year prior to enrollment in the study
* Age 40 years or older
Exclusion Criteria
* Evidence of temporal arteritis
* History of vasculitis or collagen vascular disease
* Previous history of NAION
40 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Greider Eye Associates
Vista, California, United States
Palm Beach Eye Center
Atlantis, Florida, United States
West Coast Eye Care
Fort Myers, Florida, United States
National Ophthalmic Research Institute
Fort Myers, Florida, United States
Sarasota Retina Institute
Sarasota, Florida, United States
Midwest Eye Institute
Indianapolis, Indiana, United States
Spoor and Associates
Warren, Michigan, United States
Asheville Eye Associates
Asheville, North Carolina, United States
Office of Dr. Avrom Epstein, MD
Columbus, Ohio, United States
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, United States
Retinal and Ophthalmic Consultants
Houston, Texas, United States
Save Sight Institute
Sydney, New South Wales, Australia
Midwest Eye Institute
Toronto, Ontario, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2010-023586-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12912
Identifier Type: -
Identifier Source: org_study_id
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