A Study to Determine if There is a Possible Association Between NAION and Phosphodiesterase Type 5 (PDE5) Inhibitors

Nonarteritic Anterior Ischemic Optic Neuropathy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01131104
• Other study ID #: 11638
• Secondary ID: H6D-MC-LVHQ
• Status: Completed
• First received: May 10, 2010
• Last updated: September 5, 2017
• Start date: May 2010
• Est. completion date: December 2015

Study information

• Verified date: September 2017
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Nonarteritic Anterior Ischemic Optic Neuropathy
• Optic Nerve Diseases
• Optic Neuropathy, Ischemic

Intervention

Drug:
• PDE5 Inhibitors
Observational study of participants who have been prescribed phosphodiesterase type 5 (PDE5) inhibitors by their physician during routine clinical practice.

Locations

Country	Name	City	State
United States	Bethesda Neurology, LLC	Bethesda	Maryland
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	Longwood Medical Eye Center	Boston	Massachusetts
United States	Retina Consultants of Charleston	Charleston	South Carolina
United States	University of Illinois At Chicago Med Center	Chicago	Illinois
United States	Ohio State Univ College Of Medicine	Columbus	Ohio
United States	Henry Ford Health System	Dearborn	Michigan
United States	Avail Clinical Research LLC	DeLand	Florida
United States	Stony Brook University Medical Center	East Setauket	New York
United States	JFK Medical Center, NJ Neuroscience Institute	Edison	New Jersey
United States	Northwestern University	Evanston	Illinois
United States	University of Florida - Gainesville	Gainesville	Florida
United States	Northshore Eye and Vision Center	Glenview	Illinois
United States	Neuro-Opthalmology of Texas	Houston	Texas
United States	Midwest Eye Institute	Indianapolis	Indiana
United States	Florida Retina Consultants	Lakeland	Florida
United States	Family Eye Care	Lancaster	Pennsylvania
United States	Univ KY Clinical Resch Org- KY Clinic	Lexington	Kentucky
United States	Cockerham Eye Consultant	Los Altos	California
United States	University of Miami School of Medicine	Miami	Florida
United States	University of Minnesota Medical School	Minneapolis	Minnesota
United States	Precision Eye Care	National City	California
United States	The Eye Care Group	New Haven	Connecticut
United States	E.S. Harkness Eye Institute	New York	New York
United States	Dr. Daniel Lin	Oregon	Ohio
United States	Paducah Retinal Center	Paducah	Kentucky
United States	North Bay Eye Associates, Inc.	Petaluma	California
United States	University of Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Allegheny Ophthalmic & Orbital Associates	Pittsburgh	Pennsylvania
United States	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	Neuro-Ophthalmic Services	Royal Oak	Michigan
United States	Saint Louis University	Saint Louis	Missouri
United States	PMG Research of Salisbury	Salisbury	North Carolina
United States	University of Utah Health Sciences Center	Salt Lake City	Utah
United States	Medical Center Ophthalmology Associates	San Antonio	Texas
United States	Russell P Edwards M.D.	San Diego	California
United States	Pacific Eye Associates	San Francisco	California
United States	Sarasota Retina Institute	Sarasota	Florida
United States	Swedish Neuroscience Institute	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington
United States	USF Eye Institute	Tampa	Florida
United States	Montefiore Medical Center	The Bronx	New York
United States	Eye Surgical & Medical Associates, Inc.	Visalia	California
United States	Atlantic Clinical Trials, LLC	Watertown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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