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

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ClinicalTrials.gov Identifier: NCT01131104
Recruitment Status : Completed
First Posted : May 26, 2010
Results First Posted : April 5, 2018
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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 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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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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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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01131104


  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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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    Key Record Dates
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