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

• Status: Terminated
• Trial end date: 2018-03-28
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Phosphodiesterase 5 Inhibitors

Criteria

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