Status:
TERMINATED
PDE5 Inhibitor Use and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Lead Sponsor:
Bayer
Conditions:
Anterior Ischemic Optic Neuropathy
Eligibility:
MALE
40+ years
Phase:
PHASE4
Brief 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.
Detailed Description
Collected data will be compared to historic data of the same participant in case-crossover design.
Eligibility Criteria
Inclusion
- 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
- History of multiple sclerosis or optic neuritis
- Evidence of temporal arteritis
- History of vasculitis or collagen vascular disease
- Previous history of NAION
Key Trial Info
Start Date :
July 13 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00867815
Start Date
July 13 2009
End Date
March 28 2018
Last Update
January 23 2019
Active Locations (13)
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1
Greider Eye Associates
Vista, California, United States, 92083
2
Palm Beach Eye Center
Atlantis, Florida, United States, 33461
3
West Coast Eye Care
Fort Myers, Florida, United States, 33908
4
National Ophthalmic Research Institute
Fort Myers, Florida, United States, 33912