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

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00867815

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:	Allocation: Non-Randomized 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:

Genetics Home Reference related topics: Charcot-Marie-Tooth disease

MedlinePlus related topics: Erectile Dysfunction

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 68 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

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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 8, 2012
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:

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

Sexual Dysfunction, Physiological
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 24, 2012