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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00867815
Recruitment Status : Terminated
First Posted : March 24, 2009
Results First Posted : January 23, 2019
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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 or disease Intervention/treatment Phase
Anterior Ischemic Optic Neuropathy Drug: Diagnostic procedures Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
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 Increases the Risk for the Development of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Actual Study Start Date : July 13, 2009
Actual Primary Completion Date : December 29, 2017
Actual Study Completion Date : March 28, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Number of Participants With Confirmed Diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) [ Time Frame: Up to 45 days prior to study enrollment ]
    The study population consisted of adult men, first diagnosed with NAION which started within 45 days before study start and took PDE5 inhibitors (vardenafil, sildenafil, tadalafil or avanafil) in the 1 year prior to enrollment.


Secondary Outcome Measures :
  1. Number of Participants With Most Frequent Medical History Findings by Primary System Organ Class at Visit 1 [ Time Frame: Day 1 ]
    The safety population includes participants who signed informed consent and who had any of the following collected at Visit 1 for safety: laboratory values, physical exam, any eye exams, or adverse events.

  2. Number of Participants With Any Adverse Events Reported at Visit 2 [ Time Frame: From informed consent signed up to Visit 2 (Day 90+/-30) ]
    An adverse event is any untoward medical occurrence in a subject or clinical investigation subject and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally occurring during the trial.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • NAION onset within 45 days before entry to the study
  • NAION onset definable by the subject within a 2 calendar day window
  • Men who have taken at least 1 dose of PDE5 inhibitor(s) at any time in the 1 year prior to enrollment in the study
  • 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

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


Locations
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United States, California
Greider Eye Associates
Vista, California, United States, 92083
United States, Florida
Palm Beach Eye Center
Atlantis, Florida, United States, 33461
West Coast Eye Care
Fort Myers, Florida, United States, 33908
National Ophthalmic Research Institute
Fort Myers, Florida, United States, 33912
Sarasota Retina Institute
Sarasota, Florida, United States, 34239
United States, Indiana
Midwest Eye Institute
Indianapolis, Indiana, United States, 46290
United States, Michigan
Spoor and Associates
Warren, Michigan, United States, 48088
United States, North Carolina
Asheville Eye Associates
Asheville, North Carolina, United States, 28803
United States, Ohio
Office of Dr. Avrom Epstein, MD
Columbus, Ohio, United States, 43215-7312
United States, Oklahoma
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, United States, 74014
United States, Texas
Retinal and Ophthalmic Consultants
Houston, Texas, United States, 77030
Australia, New South Wales
Save Sight Institute
Sydney, New South Wales, Australia, 2000
Canada, Ontario
Midwest Eye Institute
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
  Study Documents (Full-Text)

Documents provided by Bayer:
Study Protocol  [PDF] March 2, 2016
Statistical Analysis Plan  [PDF] March 20, 2018

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00867815    
Other Study ID Numbers: 12912
2010-023586-22 ( EudraCT Number )
First Posted: March 24, 2009    Key Record Dates
Results First Posted: January 23, 2019
Last Update Posted: January 23, 2019
Last Verified: January 2019

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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:
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Peripheral Nervous System Diseases
Optic Nerve Diseases
Optic Neuropathy, Ischemic
Ischemia
Pathologic Processes
Neuromuscular Diseases
Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases