A Study to Assess Whether PDE5 Inhibitors Increase the Chance of Triggering the Onset of Acute NAION

Completed

Conditions studied: Optic Neuropathy, Ischemic

In brief

The objective of this non-interventional study is to examine whether use of Phosphodiesterase Inhibitors (PDE5s), including use of sildenafil, vardenafil, or tadalafil, triggers the onset of acute NAION.

Key facts

Study ID

NCT00759174

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

673

Starts

2008-11-01

Expected to finish

2012-10-01

Last updated by the study team

2021-02-01

Who can join

Age: 45 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male aged ≥45 years;
• Experienced abrupt visual change in only 1 eye

You may not qualify if…

• Pain determined by an ophthalmologist to be consistent with an inflammatory/arteritic process or optic neuritis;
• History of NAION or optic neuritis.
• Participation in other studies within 60 days prior to entry in the study.

Where it is running

• Pfizer Investigational Site — Mobile, Alabama, United States
• Pfizer Investigational Site — Anchorage, Alaska, United States
• Pfizer Investigational Site — Little Rock, Arkansas, United States
• Pfizer Investigational Site — Little Rock, Arkansas, United States
• Pfizer Investigational Site — Loma Linda, California, United States
• Pfizer Investigational Site — Long Beach, California, United States
• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — Oceanside, California, United States
• Pfizer Investigational Site — Pasadena, California, United States
• Pfizer Investigational Site — Aurora, Colorado, United States
• Pfizer Investigational Site — New Haven, Connecticut, United States
• Pfizer Investigational Site — Southbury, Connecticut, United States
• Pfizer Investigational Site — Waterbury, Connecticut, United States
• Pfizer Investigational Site — Washington D.C., District of Columbia, United States
• Pfizer Investigational Site — Washington D.C., District of Columbia, United States
• Pfizer Investigational Site — Bradenton, Florida, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Tampa, Florida, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Augusta, Georgia, United States
• Pfizer Investigational Site — Lisle, Illinois, United States
• Pfizer Investigational Site — Dubuque, Iowa, United States
• Pfizer Investigational Site — Prairie Village, Kansas, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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