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

Completed

Conditions studied: Nonarteritic Anterior Ischemic Optic Neuropathy

In brief

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.

Key facts

Study ID

NCT01131104

Run by

Eli Lilly and Company

People needed

345

Starts

2010-05-01

Expected to finish

2015-12-01

Last updated by the study team

2018-04-05

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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

Where it is running

• University of Alabama Birmingham — Birmingham, Alabama, United States
• Cockerham Eye Consultant — Los Altos, California, United States
• Precision Eye Care — National City, California, United States
• North Bay Eye Associates, Inc. — Petaluma, California, United States
• Russell P Edwards M.D. — San Diego, California, United States
• Pacific Eye Associates — San Francisco, California, United States
• Eye Surgical & Medical Associates, Inc. — Visalia, California, United States
• The Eye Care Group — New Haven, Connecticut, United States
• Avail Clinical Research LLC — DeLand, Florida, United States
• University of Florida - Gainesville — Gainesville, Florida, United States
• Florida Retina Consultants — Lakeland, Florida, United States
• University of Miami School of Medicine — Miami, Florida, United States
• Sarasota Retina Institute — Sarasota, Florida, United States
• USF Eye Institute — Tampa, Florida, United States
• University of Illinois At Chicago Med Center — Chicago, Illinois, United States
• Northwestern University — Evanston, Illinois, United States
• Northshore Eye and Vision Center — Glenview, Illinois, United States
• Midwest Eye Institute — Indianapolis, Indiana, United States
• Univ KY Clinical Resch Org- KY Clinic — Lexington, Kentucky, United States
• Paducah Retinal Center — Paducah, Kentucky, United States
• Bethesda Neurology, LLC — Bethesda, Maryland, United States
• Longwood Medical Eye Center — Boston, Massachusetts, United States
• Atlantic Clinical Trials, LLC — Watertown, Massachusetts, United States
• Henry Ford Health System — Dearborn, Michigan, United States
• Neuro-Ophthalmic Services — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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