Anterior Ischemic Optic Neuropathy | PDE5 Inhibitor Use and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Anterior Ischemic Optic Neuropathy research study
What is the primary objective of this study?
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 is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Anterior Ischemic Optic Neuropathy
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Diagnostic proceduresThe patients will not receive any study drug in this study. The patients will have ophthalmological (eye) examinations, blood work and will complete an interview
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: July 13, 2009
Completed Date: March 28, 2018
Phase: Phase 4
Primary Outcome: Number of Participants With Confirmed Diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Secondary Outcome: Number of Participants With Most Frequent Medical History Findings by Primary System Organ Class at Visit 1
Study sponsors, principal investigator, and references
Principal Investigator: Bayer Study Director
Lead Sponsor: Bayer