Trial Condition(s):
Anterior Ischemic Optic Neuropathy
PDE5 inhibitor use and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Bayer Identifier:
12912
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Midwest Eye Institute Indianapolis, United States, 46290 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sarasota Retina Institute Sarasota, United States, 34239 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Spoor and Associates Warren, United States, 48088 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations West Coast Eye Care Fort Myers, United States, 33908 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retinal and Ophthalmic Consultants Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Palm Beach Eye Center Atlantis, United States, 33461 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Asheville Eye Associates Asheville, United States, 28803 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Office of Dr. Avrom Epstein, MD Columbus, United States, 43215-7312 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Midwest Eye Institute Toronto, Canada, M5G 1X5 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Ophthalmic Research Institute Fort Myers, United States, 33912 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Greider Eye Associates Vista, United States, 92083 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tulsa Clinical Research, LLC Tulsa, United States, 74014 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Save Sight Institute Sydney, Australia, 2000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Prospective Case Crossover Study to Assess Whether PDE5 Inhibitor Exposure in Men Increases the Risk for the Development of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Confirmed diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION).Timeframe: Up to 45 days prior to study enrollment
Secondary Outcome
- Any additional safety information provided by the subject.Timeframe: From Baseline to Visit 2 (Day 90+/-30)
Additional Information
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