Nonarteritic Anterior Ischemic Optic NeuropathyNCT01131104
A Study to Determine if There is a Possible Association Between NAION and Phosphodiesterase Type 5 (PDE5) Inhibitors
An observational study of Nonarteritic Anterior Ischemic Optic Neuropathy, run by Eli Lilly and Company at 44 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Nonarteritic Anterior Ischemic Optic Neuropathy
- What is being tested?
- PDE5 Inhibitors
- How many people
- 345 participants
- Where
- 44 sitesUnited States
- Study dates
- May 2010to Dec 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Potential cases of acute NAION will be prospectively identified by approximately 20 neuro-ophthalmology centers in the US
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Bethesda Neurology, LLC
Bethesda, Maryland, 20814
University of Alabama Birmingham
Birmingham, Alabama, 35295
Longwood Medical Eye Center
Boston, Massachusetts, 02215
Retina Consultants of Charleston
Charleston, South Carolina, 29414
University of Illinois At Chicago Med Center
Chicago, Illinois, 60612
Ohio State Univ College Of Medicine
Columbus, Ohio, 46210
Henry Ford Health System
Dearborn, Michigan, 48126
Avail Clinical Research LLC
DeLand, Florida, 32720
Stony Brook University Medical Center
East Setauket, New York, 11733
JFK Medical Center, NJ Neuroscience Institute
Edison, New Jersey, 08820
Northwestern University
Evanston, Illinois, 60208
University of Florida - Gainesville
Gainesville, Florida, 32611
Northshore Eye and Vision Center
Glenview, Illinois, 60026
Neuro-Opthalmology of Texas
Houston, Texas, 77030
Midwest Eye Institute
Indianapolis, Indiana, 46290
Florida Retina Consultants
Lakeland, Florida, 33805
Family Eye Care
Lancaster, Pennsylvania, 17601
Univ KY Clinical Resch Org- KY Clinic
Lexington, Kentucky, 40536
Cockerham Eye Consultant
Los Altos, California, 94024
University of Miami School of Medicine
Miami, Florida, 33136
University of Minnesota Medical School
Minneapolis, Minnesota, 55455
Precision Eye Care
National City, California, 91950
The Eye Care Group
New Haven, Connecticut, 06708
E.S. Harkness Eye Institute
New York, New York, 10032
Dr. Daniel Lin
Oregon, Ohio, 43616
Paducah Retinal Center
Paducah, Kentucky, 42001
North Bay Eye Associates, Inc.
Petaluma, California, 94954
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
Allegheny Ophthalmic & Orbital Associates
Pittsburgh, Pennsylvania, 15212
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
Neuro-Ophthalmic Services
Royal Oak, Michigan, 48073
PMG Research of Salisbury
Salisbury, North Carolina, 28144
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
Russell P Edwards M.D.
San Diego, California, 92103
Pacific Eye Associates
San Francisco, California, 94115
Sarasota Retina Institute
Sarasota, Florida, 34239
University of Washington Medical Center
Seattle, Washington, 98104
Swedish Neuroscience Institute
Seattle, Washington, 98122
Saint Louis University
St Louis, Missouri, 63104
USF Eye Institute
Tampa, Florida, 33612
Montefiore Medical Center
The Bronx, New York, 10467
Eye Surgical & Medical Associates, Inc.
Visalia, California, 93277
Atlantic Clinical Trials, LLC
Watertown, Massachusetts, 02472
About this study
Official title: 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.
- Being tested
- PDE5 Inhibitors
- Keywords
- NAION
- Medical subject headings
- Optic Neuropathy, Ischemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDE5 InhibitorsDrug
Also called tadalafil, sildenafil, vardenafil
Observational study of participants who have been prescribed phosphodiesterase type 5 (PDE5) inhibitors by their physician during routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants with NAION who have used PDE5 inhibitors Receives: Drug: PDE5 Inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days prior to NAION onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nonarteritic Anterior Ischemic Optic NeuropathyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131104
- Sponsor's protocol ID
- 11638
- Other IDs
- H6D-MC-LVHQ
- Status last verified
- Sep 2017
- First submitted
- 10 May 2010
- Last updated
- 5 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01131104
- Acronym / sponsor ID
- 11638
- Keywords
- NAION
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 May 2010 (estimated)
- Results
- Posted 5 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: PDE5 InhibitorsParticipants with NAION who have used PDE5 inhibitors |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential cases of acute NAION will be prospectively identified by approximately 20 neuro-ophthalmology centers in the US
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PDE5 InhibitorsAlso: tadalafil, sildenafil, vardenafilObservational study of participants who have been prescribed phosphodiesterase type 5 (PDE5) inhibitors by their physician during routine clinical practice. | Drug | Cohort 1 |
Primary outcome
30-Day Person Time Analysis Risk of NAION Associated With PDE5 Inhibitor Use
Time frame: 30 days prior to NAION onset
Total participant days of PDE5 inhibitor exposure within 30 days prior to onset of NAION.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonarteritic Anterior Ischemic Optic Neuropathy, run by Eli Lilly and Company at 44 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-Day Person Time Analysis Risk of NAION Associated With PDE5 Inhibitor Use (time frame: 30 days prior to NAION onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.