Back to resultsPDE5 Inhibitor Use and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Primary Purpose
Anterior Ischemic Optic Neuropathy
Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Diagnostic procedures
Sponsored by
About this trial
This is an interventional other trial for Anterior Ischemic Optic Neuropathy focused on measuring 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.
Eligibility 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
Sites / Locations
- Greider Eye Associates
- Palm Beach Eye Center
- West Coast Eye Care
- National Ophthalmic Research Institute
- Sarasota Retina Institute
- Midwest Eye Institute
- Spoor and Associates
- Asheville Eye Associates
- Office of Dr. Avrom Epstein, MD
- Tulsa Clinical Research, LLC
- Retinal and Ophthalmic Consultants
- Save Sight Institute
- Midwest Eye Institute
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Confirmed Diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
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
Number of Participants With Most Frequent Medical History Findings by Primary System Organ Class at Visit 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.
Number of Participants With Any Adverse Events Reported at Visit 2
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00867815
Brief Title
PDE5 Inhibitor Use and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Study Start Date
July 13, 2009 (Actual)
Primary Completion Date
December 29, 2017 (Actual)
Study Completion Date
March 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Collected data will be compared to historic data of the same participant in case-crossover design.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Ischemic Optic Neuropathy
Keywords
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.
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Diagnostic procedures
Intervention Description
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 Measure Information:
Title
Number of Participants With Confirmed Diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Description
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.
Time Frame
Up to 45 days prior to study enrollment
Secondary Outcome Measure Information:
Title
Number of Participants With Most Frequent Medical History Findings by Primary System Organ Class at Visit 1
Description
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.
Time Frame
Day 1
Title
Number of Participants With Any Adverse Events Reported at Visit 2
Description
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.
Time Frame
From informed consent signed up to Visit 2 (Day 90+/-30)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
Facility Name
Greider Eye Associates
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Palm Beach Eye Center
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
West Coast Eye Care
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Facility Name
National Ophthalmic Research Institute
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Sarasota Retina Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Midwest Eye Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Spoor and Associates
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Asheville Eye Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Office of Dr. Avrom Epstein, MD
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215-7312
Country
United States
Facility Name
Tulsa Clinical Research, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74014
Country
United States
Facility Name
Retinal and Ophthalmic Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Save Sight Institute
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Midwest Eye Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
12. IPD Sharing Statement
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PDE5 Inhibitor Use and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
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