TerminatedPhase 4

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

United States10 participantsStarted 2009-07-13

Plain-language 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.

Who can participate

Age range40 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants With Confirmed Diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)

Timeframe: Up to 45 days prior to study enrollment

Trial details

NCT IDNCT00867815

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-12-29

Results submitted2018-12-26

View on ClinicalTrials.gov More Anterior Ischemic Optic Neuropathy trials