Clinical trial NCT01131104: A Study to Determine if There is a Possible Association Between NAION and Phosphodiesterase Type 5 (PDE5) Inhibitors
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nonarteritic Anterior Ischemic Optic Neuropathy
Keywords: NAION
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2010-05-26
Enrollment: 345
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: 30-Day Person Time Analysis Risk of NAION Associated With PDE5 Inhibitor Use
timeFrame: 30 days prior to NAION onset
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Los Altos
country: United States
facility: Cockerham Eye Consultant
state: California
city: National City
country: United States
facility: Precision Eye Care
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates, Inc.
state: California
city: San Diego
country: United States
facility: Russell P Edwards M.D.
state: California
city: San Francisco
country: United States
facility: Pacific Eye Associates
state: California
city: Visalia
country: United States
facility: Eye Surgical & Medical Associates, Inc.
state: California
city: New Haven
country: United States
facility: The Eye Care Group
state: Connecticut
city: DeLand
country: United States
facility: Avail Clinical Research LLC
state: Florida
city: Gainesville
country: United States
facility: University of Florida - Gainesville
state: Florida
city: Lakeland
country: United States
facility: Florida Retina Consultants
state: Florida
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Sarasota
country: United States
facility: Sarasota Retina Institute
state: Florida
city: Tampa
country: United States
facility: USF Eye Institute
state: Florida
city: Chicago
country: United States
facility: University of Illinois At Chicago Med Center
state: Illinois
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Glenview
country: United States
facility: Northshore Eye and Vision Center
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Eye Institute
state: Indiana
city: Lexington
country: United States
facility: Univ KY Clinical Resch Org- KY Clinic
state: Kentucky
city: Paducah
country: United States
facility: Paducah Retinal Center
state: Kentucky
city: Bethesda
country: United States
facility: Bethesda Neurology, LLC
state: Maryland
city: Boston
country: United States
facility: Longwood Medical Eye Center
state: Massachusetts
city: Watertown
country: United States
facility: Atlantic Clinical Trials, LLC
state: Massachusetts
city: Dearborn
country: United States
facility: Henry Ford Health System
state: Michigan
city: Royal Oak
country: United States
facility: Neuro-Ophthalmic Services
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical School
state: Minnesota
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Edison
country: United States
facility: JFK Medical Center, NJ Neuroscience Institute
state: New Jersey
city: East Setauket
country: United States
facility: Stony Brook University Medical Center
state: New York
city: New York
country: United States
facility: E.S. Harkness Eye Institute
state: New York
city: The Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Salisbury
country: United States
facility: PMG Research of Salisbury
state: North Carolina
city: Columbus
country: United States
facility: Ohio State Univ College Of Medicine
state: Ohio
city: Oregon
country: United States
facility: Dr. Daniel Lin
state: Ohio
city: Lancaster
country: United States
facility: Family Eye Care
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Ophthalmic & Orbital Associates
state: Pennsylvania
city: Charleston
country: United States
facility: Retina Consultants of Charleston
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Houston
country: United States
facility: Neuro-Opthalmology of Texas
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Seattle
country: United States
facility: Swedish Neuroscience Institute
state: Washington
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: