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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01131104
First received: May 10, 2010
Last updated: February 15, 2016
Last verified: February 2016
History of Changes
  Purpose
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 Intervention
Nonarteritic Anterior Ischemic Optic Neuropathy
 Drug: PDE5 Inhibitors

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of patients with adjudicated NAION diagnosis and who are non-chronic users of PDE5 inhibitors. [ Time Frame: day 1 ] [ Designated as safety issue: Yes ]
Enrollment: 312
Study Start Date: May 2010
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort 1
Patients 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.

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders 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
  • Patients 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01131104     History of Changes
Other Study ID Numbers: 11638  H6D-MC-LVHQ 
Study First Received: May 10, 2010
Last Updated: February 15, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 23, 2016