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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00867815
Recruitment Status : Terminated
First Posted : March 24, 2009
Last Update Posted : April 18, 2018
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Anterior Ischemic Optic Neuropathy Drug: Diagnostic procedures Phase 4

Detailed Description:
Collected data will be compared to historic data of the same participant in case-crossover design.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Prospective Case Crossover Study to Assess Whether PDE5 Inhibitor Exposure in Men With Erectile Dysfunction Increases the Risk for the Development of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Actual Study Start Date : July 13, 2009
Actual Primary Completion Date : December 29, 2017
Actual Study Completion Date : March 28, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Arm 1 Drug: Diagnostic procedures
The patients will not receive any study drug in this study. The patients will have ophthalmological (eye) examinations, blood work and will complete an interview

Primary Outcome Measures :
  1. Confirmed diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION). [ Time Frame: Up to 67 days prior to study enrollment ]

Secondary Outcome Measures :
  1. Any additional safety information provided by the subject. [ Time Frame: At baseline and after 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00867815

United States, California
Greider Eye Associates
Vista, California, United States, 92083
United States, Florida
Palm Beach Eye Center
Atlantis, Florida, United States, 33461
West Coast Eye Care
Fort Myers, Florida, United States, 33908
National Ophthalmic Research Institute
Fort Myers, Florida, United States, 33912
Sarasota Retina Institute
Sarasota, Florida, United States, 34239
United States, Indiana
Midwest Eye Institute
Indianapolis, Indiana, United States, 46290
United States, Michigan
Spoor and Associates
Warren, Michigan, United States, 48088
United States, North Carolina
Asheville Eye Associates
Asheville, North Carolina, United States, 28803
United States, Ohio
Office of Dr. Avrom Epstein, MD
Columbus, Ohio, United States, 43215-7312
United States, Oklahoma
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, United States, 74014
United States, Texas
Retinal and Ophthalmic Consultants
Houston, Texas, United States, 77030
Australia, New South Wales
Save Sight Institute
Sydney, New South Wales, Australia, 2000
Canada, Ontario
Midwest Eye Institute
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT00867815     History of Changes
Other Study ID Numbers: 12912
2010-023586-22 ( EudraCT Number )
First Posted: March 24, 2009    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Non-arteritic Anterior Ischemic Optic Neuropathy
PDE5 inhibitors
acute vision loss
vision loss
blurred vision
optic neuropathy
erectile dysfunction.

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Erectile Dysfunction
Optic Nerve Diseases
Optic Neuropathy, Ischemic
Pathologic Processes
Neuromuscular Diseases
Nervous System Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Cranial Nerve Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action