A Study to Determine if There is a Possible Association Between NAION and Phosphodiesterase Type 5 (PDE5) Inhibitors
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)
2 other identifiers
observational
345
1 country
44
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2010
Longer than P75 for all trials
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 10, 2010
CompletedFirst Posted
Study publicly available on registry
May 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
April 5, 2018
CompletedApril 5, 2018
September 1, 2017
5.6 years
May 10, 2010
December 8, 2016
September 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
30-Day Person Time Analysis Risk of NAION Associated With PDE5 Inhibitor Use
Total participant days of PDE5 inhibitor exposure within 30 days prior to onset of NAION.
30 days prior to NAION onset
Study Arms (1)
Cohort 1
Participants with NAION who have used PDE5 inhibitors
Interventions
Observational study of participants who have been prescribed phosphodiesterase type 5 (PDE5) inhibitors by their physician during routine clinical practice.
Eligibility Criteria
Potential cases of acute NAION will be prospectively identified by approximately 20 neuro-ophthalmology centers in the US
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
University of Alabama Birmingham
Birmingham, Alabama, 35295, United States
Cockerham Eye Consultant
Los Altos, California, 94024, United States
Precision Eye Care
National City, California, 91950, United States
North Bay Eye Associates, Inc.
Petaluma, California, 94954, United States
Russell P Edwards M.D.
San Diego, California, 92103, United States
Pacific Eye Associates
San Francisco, California, 94115, United States
Eye Surgical & Medical Associates, Inc.
Visalia, California, 93277, United States
The Eye Care Group
New Haven, Connecticut, 06708, United States
Avail Clinical Research LLC
DeLand, Florida, 32720, United States
University of Florida - Gainesville
Gainesville, Florida, 32611, United States
Florida Retina Consultants
Lakeland, Florida, 33805, United States
University of Miami School of Medicine
Miami, Florida, 33136, United States
Sarasota Retina Institute
Sarasota, Florida, 34239, United States
USF Eye Institute
Tampa, Florida, 33612, United States
University of Illinois At Chicago Med Center
Chicago, Illinois, 60612, United States
Northwestern University
Evanston, Illinois, 60208, United States
Northshore Eye and Vision Center
Glenview, Illinois, 60026, United States
Midwest Eye Institute
Indianapolis, Indiana, 46290, United States
Univ KY Clinical Resch Org- KY Clinic
Lexington, Kentucky, 40536, United States
Paducah Retinal Center
Paducah, Kentucky, 42001, United States
Bethesda Neurology, LLC
Bethesda, Maryland, 20814, United States
Longwood Medical Eye Center
Boston, Massachusetts, 02215, United States
Atlantic Clinical Trials, LLC
Watertown, Massachusetts, 02472, United States
Henry Ford Health System
Dearborn, Michigan, 48126, United States
Neuro-Ophthalmic Services
Royal Oak, Michigan, 48073, United States
University of Minnesota Medical School
Minneapolis, Minnesota, 55455, United States
Saint Louis University
St Louis, Missouri, 63104, United States
JFK Medical Center, NJ Neuroscience Institute
Edison, New Jersey, 08820, United States
Stony Brook University Medical Center
East Setauket, New York, 11733, United States
E.S. Harkness Eye Institute
New York, New York, 10032, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
PMG Research of Salisbury
Salisbury, North Carolina, 28144, United States
Ohio State Univ College Of Medicine
Columbus, Ohio, 46210, United States
Dr. Daniel Lin
Oregon, Ohio, 43616, United States
Family Eye Care
Lancaster, Pennsylvania, 17601, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104, United States
Allegheny Ophthalmic & Orbital Associates
Pittsburgh, Pennsylvania, 15212, United States
Retina Consultants of Charleston
Charleston, South Carolina, 29414, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701, United States
Neuro-Opthalmology of Texas
Houston, Texas, 77030, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132, United States
University of Washington Medical Center
Seattle, Washington, 98104, United States
Swedish Neuroscience Institute
Seattle, Washington, 98122, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2010
First Posted
May 26, 2010
Study Start
May 1, 2010
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
April 5, 2018
Results First Posted
April 5, 2018
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share