- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01131104
A Study to Determine if There is a Possible Association Between NAION and Phosphodiesterase Type 5 (PDE5) Inhibitors
September 5, 2017 updated by: Eli Lilly and Company
A Prospective Case-crossover Study to Evaluate the Possible Association Between the Use of PDE5 Inhibitors and the Risk of Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
Study H6D-MC-LVHQ is an observational, non-interventional, multi-center, prospective, case-crossover study to evaluate the possible association between the use of phosphodiesterase type 5 (PDE5) inhibitors and the risk of acute nonarteritic anterior ischemic optic neuropathy (NAION) in males.
Subjects with newly diagnosed NAION will be asked via a structured questionnaire about their use of PDE5 inhibitors and other risk factors prior to the onset of their vision loss.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
345
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35295
- University of Alabama Birmingham
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California
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Los Altos, California, United States, 94024
- Cockerham Eye Consultant
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National City, California, United States, 91950
- Precision Eye Care
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Petaluma, California, United States, 94954
- North Bay Eye Associates, Inc.
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San Diego, California, United States, 92103
- Russell P Edwards M.D.
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San Francisco, California, United States, 94115
- Pacific Eye Associates
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Visalia, California, United States, 93277
- Eye Surgical & Medical Associates, Inc.
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Connecticut
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New Haven, Connecticut, United States, 06708
- The Eye Care Group
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Florida
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DeLand, Florida, United States, 32720
- Avail Clinical Research LLC
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Gainesville, Florida, United States, 32611
- University of Florida - Gainesville
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Lakeland, Florida, United States, 33805
- Florida Retina Consultants
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Miami, Florida, United States, 33136
- University of Miami School of Medicine
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Sarasota, Florida, United States, 34239
- Sarasota Retina Institute
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Tampa, Florida, United States, 33612
- USF Eye Institute
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Illinois
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Chicago, Illinois, United States, 60612
- University of Illinois At Chicago Med Center
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Evanston, Illinois, United States, 60208
- Northwestern University
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Glenview, Illinois, United States, 60026
- Northshore Eye and Vision Center
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Indiana
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Indianapolis, Indiana, United States, 46290
- Midwest Eye Institute
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Kentucky
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Lexington, Kentucky, United States, 40536
- Univ KY Clinical Resch Org- KY Clinic
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Paducah, Kentucky, United States, 42001
- Paducah Retinal Center
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Maryland
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Bethesda, Maryland, United States, 20814
- Bethesda Neurology, LLC
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Longwood Medical Eye Center
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Watertown, Massachusetts, United States, 02472
- Atlantic Clinical Trials, Llc
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Michigan
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Dearborn, Michigan, United States, 48126
- Henry Ford Health System
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Royal Oak, Michigan, United States, 48073
- Neuro-Ophthalmic Services
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Medical School
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Missouri
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Saint Louis, Missouri, United States, 63104
- Saint Louis University
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New Jersey
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Edison, New Jersey, United States, 08820
- JFK Medical Center, NJ Neuroscience Institute
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New York
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East Setauket, New York, United States, 11733
- Stony Brook University Medical Center
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New York, New York, United States, 10032
- E.S. Harkness Eye Institute
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The Bronx, New York, United States, 10467
- Montefiore Medical Center
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North Carolina
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Salisbury, North Carolina, United States, 28144
- PMG Research of Salisbury
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Ohio
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Columbus, Ohio, United States, 46210
- Ohio State Univ College Of Medicine
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Oregon, Ohio, United States, 43616
- Dr. Daniel Lin
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Pennsylvania
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Lancaster, Pennsylvania, United States, 17601
- Family Eye Care
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania Hospital
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Pittsburgh, Pennsylvania, United States, 15212
- Allegheny Ophthalmic & Orbital Associates
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South Carolina
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Charleston, South Carolina, United States, 29414
- Retina Consultants of Charleston
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South Dakota
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Rapid City, South Dakota, United States, 57701
- Black Hills Regional Eye Institute
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Texas
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Houston, Texas, United States, 77030
- Neuro-Opthalmology of Texas
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San Antonio, Texas, United States, 78240
- Medical Center Ophthalmology Associates
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Utah
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Salt Lake City, Utah, United States, 84132
- University of Utah Health Sciences Center
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Washington
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Seattle, Washington, United States, 98122
- Swedish Neuroscience Institute
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Seattle, Washington, United States, 98104
- University of Washington Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Potential cases of acute NAION will be prospectively identified by approximately 20 neuro-ophthalmology centers in the US
Description
Inclusion Criteria:
- Adult male subjects, at least 18 years of age, who are willing to participate in the study
- Participants who experienced abrupt visual loss in one eye (defined as typically less than a 1-day period or visual loss noted upon awakening) and presented for an initial visit within 45 days of onset of NAION symptoms to an ophthalmologist that resulted in a diagnosis of Suspected NAION by the investigator
Exclusion Criteria:
- Previous history of NAION
- Previous history of arteritis (anywhere in the body) or clinical or diagnostic testing evidence of temporal arteritis
- History of glaucoma in either one or both eyes
- History of multiple sclerosis or diagnostic testing evidence of optic neuritis
- Have dementia or other reasons for memory impairment in the opinion of the investigator
- Have participated in other non-observational studies within 3 months of NAION onset
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Cohort 1
Participants with NAION who have used PDE5 inhibitors
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Observational study of participants who have been prescribed phosphodiesterase type 5 (PDE5) inhibitors by their physician during routine clinical practice.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
30-Day Person Time Analysis Risk of NAION Associated With PDE5 Inhibitor Use
Time Frame: 30 days prior to NAION onset
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Total participant days of PDE5 inhibitor exposure within 30 days prior to onset of NAION.
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30 days prior to NAION onset
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fr- 9 AM-5 PM Eastern time (UTC?GMT - 5 hours, EST), Eli Lilly and Company
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
May 10, 2010
First Submitted That Met QC Criteria
May 25, 2010
First Posted (Estimate)
May 26, 2010
Study Record Updates
Last Update Posted (Actual)
April 5, 2018
Last Update Submitted That Met QC Criteria
September 5, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Nervous System Diseases
- Eye Diseases
- Cranial Nerve Diseases
- Optic Nerve Diseases
- Optic Neuropathy, Ischemic
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Urological Agents
- Enzyme Inhibitors
- Phosphodiesterase Inhibitors
- Sildenafil Citrate
- Tadalafil
- Vardenafil Dihydrochloride
- Phosphodiesterase 5 Inhibitors
Other Study ID Numbers
- 11638
- H6D-MC-LVHQ (Other Identifier: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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