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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35295
        • University of Alabama Birmingham
    • California
      • Los Altos, California, United States, 94024
        • Cockerham Eye Consultant
      • National City, California, United States, 91950
        • Precision Eye Care
      • Petaluma, California, United States, 94954
        • North Bay Eye Associates, Inc.
      • San Diego, California, United States, 92103
        • Russell P Edwards M.D.
      • San Francisco, California, United States, 94115
        • Pacific Eye Associates
      • Visalia, California, United States, 93277
        • Eye Surgical & Medical Associates, Inc.
    • Connecticut
      • New Haven, Connecticut, United States, 06708
        • The Eye Care Group
    • Florida
      • DeLand, Florida, United States, 32720
        • Avail Clinical Research LLC
      • Gainesville, Florida, United States, 32611
        • University of Florida - Gainesville
      • Lakeland, Florida, United States, 33805
        • Florida Retina Consultants
      • Miami, Florida, United States, 33136
        • University of Miami School of Medicine
      • Sarasota, Florida, United States, 34239
        • Sarasota Retina Institute
      • Tampa, Florida, United States, 33612
        • USF Eye Institute
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois At Chicago Med Center
      • Evanston, Illinois, United States, 60208
        • Northwestern University
      • Glenview, Illinois, United States, 60026
        • Northshore Eye and Vision Center
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Midwest Eye Institute
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Univ KY Clinical Resch Org- KY Clinic
      • Paducah, Kentucky, United States, 42001
        • Paducah Retinal Center
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • Bethesda Neurology, LLC
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Longwood Medical Eye Center
      • Watertown, Massachusetts, United States, 02472
        • Atlantic Clinical Trials, Llc
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Henry Ford Health System
      • Royal Oak, Michigan, United States, 48073
        • Neuro-Ophthalmic Services
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical School
    • Missouri
      • Saint Louis, Missouri, United States, 63104
        • Saint Louis University
    • New Jersey
      • Edison, New Jersey, United States, 08820
        • JFK Medical Center, NJ Neuroscience Institute
    • New York
      • East Setauket, New York, United States, 11733
        • Stony Brook University Medical Center
      • New York, New York, United States, 10032
        • E.S. Harkness Eye Institute
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • North Carolina
      • Salisbury, North Carolina, United States, 28144
        • PMG Research of Salisbury
    • Ohio
      • Columbus, Ohio, United States, 46210
        • Ohio State Univ College Of Medicine
      • Oregon, Ohio, United States, 43616
        • Dr. Daniel Lin
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17601
        • Family Eye Care
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Hospital
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Ophthalmic & Orbital Associates
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Retina Consultants of Charleston
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Regional Eye Institute
    • Texas
      • Houston, Texas, United States, 77030
        • Neuro-Opthalmology of Texas
      • San Antonio, Texas, United States, 78240
        • Medical Center Ophthalmology Associates
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Health Sciences Center
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Neuroscience Institute
      • Seattle, Washington, United States, 98104
        • University of Washington Medical Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cohort 1
Participants with NAION who have used PDE5 inhibitors
Drug: PDE5 Inhibitors
Observational study of participants who have been prescribed phosphodiesterase type 5 (PDE5) inhibitors by their physician during routine clinical practice.
Other Names:
  • tadalafil
  • sildenafil
  • vardenafil

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Total participant days of PDE5 inhibitor exposure within 30 days prior to onset of NAION.
30 days prior to NAION onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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