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

This study is currently recruiting participants.
Verified November 2017 by Bayer
Sponsor:
ClinicalTrials.gov Identifier:
NCT00867815
First Posted: March 24, 2009
Last Update Posted: November 14, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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.

Condition Intervention Phase
Anterior Ischemic Optic Neuropathy Drug: Diagnostic procedures Phase 4

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Bayer:

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

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

Estimated Enrollment: 284
Actual Study Start Date: July 13, 2009
Estimated Study Completion Date: October 19, 2018
Estimated Primary Completion Date: September 28, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00867815


Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

  Show 80 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00867815     History of Changes
Other Study ID Numbers: 12912
2010-023586-22 ( EudraCT Number )
First Submitted: March 23, 2009
First Posted: March 24, 2009
Last Update Posted: November 14, 2017
Last Verified: November 2017

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
NAION
PDE5 inhibitors
vardenafil
Levitra
sildenafil
Viagra
Tadalafil
Cialis
acute vision loss
vision loss
blurred vision
optic neuropathy
erectile dysfunction.

Additional relevant MeSH terms:
Ischemia
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