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

This study is currently recruiting participants.
Verified May 2013 by Bayer
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00867815
First received: March 23, 2009
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  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: Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 284
Study Start Date: July 2009
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (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

Ages Eligible for Study:   40 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00867815

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

  Show 76 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00867815     History of Changes
Other Study ID Numbers: 12912, 2010-023586-22
Study First Received: March 23, 2009
Last Updated: May 6, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Italy: The Italian Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: Medicines Evaluation Board (MEB)
Australia: Department of Health and Ageing Therapeutic Goods Administration
Mexico: Ministry of Health

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:
Sexual Dysfunction, Physiological
Ischemia
Optic Nerve Diseases
Optic Neuropathy, Ischemic
Erectile Dysfunction
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Pathologic Processes
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Vascular Diseases
 Cardiovascular Diseases
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013