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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment
Nonarteritic Anterior Ischemic Optic Neuropathy	Drug: PDE5 Inhibitors

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	345 participants
Observational Model:	Case-Crossover
Time Perspective:	Prospective
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 Start Date :	May 2010
Actual Primary Completion Date :	December 2015
Actual Study Completion Date :	December 2015

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No
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

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 44 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

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

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01131104 History of Changes
Other Study ID Numbers:	11638; H6D-MC-LVHQ ( Other Identifier: Eli Lilly and Company )
First Posted:	May 26, 2010
Results First Posted:	April 5, 2018
Last Update Posted:	April 5, 2018
Last Verified:	September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Eli Lilly and Company:

NAION

Additional relevant MeSH terms:

Ischemia; Optic Nerve Diseases; Optic Neuropathy, Ischemic; Pathologic Processes; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases	Vascular Diseases; Cardiovascular Diseases; Phosphodiesterase 5 Inhibitors; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action