PDE5 Inihibitor 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 IV

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Crossover Assignment, Safety Study
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:

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 7 weeks 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 4 weeks 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 43 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer Healthcare Pharmaceuticals Inc. ( Medical Affairs Therapeutic Area Head )
Study ID Numbers:	12912
Study First Received:	March 23, 2009
Last Updated:	February 9, 2010
ClinicalTrials.gov Identifier:	NCT00867815 History of Changes
Health Authority:	United States: Food and Drug Administration

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 Dysfunctions, Psychological
Eye Diseases
Nervous System Diseases
Vascular Diseases
Ischemia
Genital Diseases, Male
Sexual and Gender Disorders
Optic Neuropathy, Ischemic

Pathologic Processes
Sexual Dysfunction, Physiological
Mental Disorders
Optic Nerve Diseases
Cardiovascular Diseases
Cranial Nerve Diseases
Erectile Dysfunction

ClinicalTrials.gov processed this record on February 09, 2010