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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: - Sudden visual loss in 1 eye within 45 days before entry to the study - History of erectile dysfunction at least 1 year prior to study enrollment - At least 1 dose of PDE5 inhibitor(s) taken within a year prior to the onset of loss of vision - 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

Study Interventions

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

Study Arms

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.

Arm 1

Study Status

Terminated

Start Date: July 13, 2009

Completed Date: March 28, 2018

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Confirmed diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION).

Secondary Outcome: Any additional safety information provided by the subject.

Study sponsors, principal investigator, and references

Principal Investigator: Bayer Study Director

Lead Sponsor: Bayer

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00867815

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