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

Condition(s) targeted: Anterior Ischemic Optic Neuropathy

Intervention: Diagnostic procedures (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

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

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

Study design: Other, Non-Randomized, Open Label, Crossover Assignment, Safety Study

Primary outcome: Confirmed diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)

Secondary outcome: Any additional safety information provided by the subject

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

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Sudden visual loss in 1 eye within 4 weeks before entry to the study

- History of erectile dysfunction at least 1 year prior to study enrollment

- At least 1 dose of PDE5 inhibitor(s) taken within a year prior to the onset of loss

of vision

- 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

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

St. Helena, California 94574, United States; Not yet recruiting

Fullerton, California 92831, United States; Not yet recruiting

Fairfield, Connecticut 06824, United States; Not yet recruiting

Fort Myers, Florida 33908, United States; Not yet recruiting

Largo, Florida 33770, United States; Not yet recruiting

Sarasota, Florida 34239, United States; Not yet recruiting

Tallahassee, Florida 32308, United States; Not yet recruiting

Miami, Florida 33155, United States; Not yet recruiting

Spring Hill, Florida 34609, United States; Not yet recruiting

Mount Dora, Florida 32757, United States; Not yet recruiting

Jacksonville, Florida 32224, United States; Not yet recruiting

Fort Myers, Florida 33901, United States; Not yet recruiting

Savannah, Georgia 31404, United States; Not yet recruiting

Skokie, Illinois 60076, United States; Not yet recruiting

Indianapolis, Indiana 46290, United States; Recruiting

Grand Rapids, Michigan 49503, United States; Not yet recruiting

Warren, Michigan 48088, United States; Not yet recruiting

Northfield, New Jersey 08225, United States; Not yet recruiting

Vestal, New York 13850, United States; Not yet recruiting

Brooklyn, New York 11219, United States; Not yet recruiting

New York, New York 10032, United States; Not yet recruiting

Asheville, North Carolina 28803, United States; Not yet recruiting

High Point, North Carolina 27262, United States; Not yet recruiting

Columbus, Ohio 43215-7312, United States; Not yet recruiting

Toronto, Ontario M5G 1X5, Canada; Not yet recruiting

Philadelphia, Pennsylvania 19104, United States; Not yet recruiting

Montreal, Quebec H2W 1S6, Canada; Not yet recruiting

Houston, Texas 77030, United States; Not yet recruiting

Houston, Texas 77025, United States; Not yet recruiting

Spokane, Washington 99204, United States; Not yet recruiting

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Starting date: July 2009
Ending date: February 2015
Last updated: September 23, 2009