PDE5 Inihibitor Use and Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) - Full Text View

Sponsored by:	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

MedlinePlus related topics: Erectile Dysfunction

U.S. FDA Resources

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)

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:	May 2009
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2011 (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

Locations

United States, California

St. Helena, California, United States, 94574
United States, Connecticut

Fairfield, Connecticut, United States, 06824
United States, Florida

Fort Myers, Florida, United States, 33908

Largo, Florida, United States, 33770

Sarasota, Florida, United States, 34239

Tallahassee, Florida, United States, 32308

Miami, Florida, United States, 33155
United States, Georgia

Savannah, Georgia, United States, 31404
United States, Illinois

Skokie, Illinois, United States, 60076
United States, Indiana

Indianapolis, Indiana, United States, 46290
United States, Michigan

Grand Rapids, Michigan, United States, 49503

Warren, Michigan, United States, 48088
United States, New Jersey

Northfield, New Jersey, United States, 08225
United States, New York

Vestal, New York, United States, 13850

Brooklyn, New York, United States, 11219
United States, Texas

Houston, Texas, United States, 77030

Houston, Texas, United States, 77025
United States, Washington

Spokane, Washington, United States, 99204
Canada, Ontario

Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec

Montreal, Quebec, Canada, H2W 1S6

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

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

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:	May 5, 2009
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

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Eye Diseases
Vascular Diseases
Optic Neuropathy, Anterior Ischemic
Sildenafil
Blindness
Ischemia
Genital Diseases, Male

Optic Neuropathy, Ischemic
Vardenafil
Sexual Dysfunction, Physiological
Mental Disorders
Optic Nerve Disorder
Tadalafil
Optic Nerve Diseases
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 May 07, 2009