N/A
N=345
A Study to Determine if There is a Possible Association Between NAION and Phosphodiesterase Type 5 (PDE5) Inhibitors
Nonarteritic Anterior Ischemic Optic Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT01131104 ↗Enrolled (actual)
345
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: 30-Day Person Time Analysis Risk of NAION Associated With PDE5 Inhibitor Use — 2.27 Relative risk of exposure
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- PDE5 Inhibitors (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Eli Lilly and Company
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 30-Day Person Time Analysis Risk of NAION Associated With PDE5 Inhibitor Use |
2.27 | — |
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
Data sourced from ClinicalTrials.gov (NCT01131104). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.