PDE5 Inhibitor Use and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)



Status:Terminated
Conditions:Erectile Dysfunction, Peripheral Vascular Disease, Neurology, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Nephrology / Urology, Neurology, Ophthalmology
Healthy:No
Age Range:40 - Any
Updated:1/25/2019
Start Date:July 13, 2009
End Date:March 28, 2018

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Prospective Case Crossover Study to Assess Whether PDE5 Inhibitor Exposure in Men Increases the Risk for the Development of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)

The primary objective of this study is to determine whether the use of PDE5 inhibitors
(vardenafil, sildenafil, or tadalafil) increases the risk for the development of NAION.

Collected data will be compared to historic data of the same participant in case-crossover
design.

Inclusion Criteria:

- NAION onset within 45 days before entry to the study

- 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:

- History of multiple sclerosis or optic neuritis

- Evidence of temporal arteritis

- History of vasculitis or collagen vascular disease

- Previous history of NAION
We found this trial at
12
sites
27450 Schoenherr Road
Warren, Michigan 48088
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Warren, MI
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8 Medical Park Drive
Asheville, North Carolina 28803
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Asheville, NC
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Atlantis, Florida 33461
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Atlantis, FL
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262 Neil Avenue
Columbus, Ohio 43215
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Columbus, OH
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15640 New Hampshire Court
Fort Myers, Florida 33908
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Fort Myers, FL
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Fort Myers, Florida 33912
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Fort Myers, FL
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Houston, Texas 77030
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Houston, TX
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Indianapolis, Indiana 46290
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Indianapolis, IN
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Sarasota, Florida 34239
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Sarasota, FL
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Sydney, New South Wales
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Sydney,
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Tulsa, Oklahoma 74104
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Tulsa, OK
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2067 West Vista Way
Vista, California 92083
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Vista, CA
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