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

Stopped early · Phase 4

Conditions studied: Anterior Ischemic Optic Neuropathy

In brief

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.

Key facts

Study ID

NCT00867815

Run by

Bayer

People needed

10

Starts

2009-07-13

Expected to finish

2018-03-28

Last updated by the study team

2019-01-23

Who can join

Age: 40 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• History of multiple sclerosis or optic neuritis
• Evidence of temporal arteritis
• History of vasculitis or collagen vascular disease
• Previous history of NAION

Where it is running

• 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

Full record on ClinicalTrials.gov

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