Nonarteritic Anterior Ischemic Optic Neuropathy
Conditions
Keywords
NAION
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.
Interventions
DRUGPDE5 Inhibitors
Observational study of participants who have been prescribed phosphodiesterase type 5 (PDE5) inhibitors by their physician during routine clinical practice.
Sponsors
Eli Lilly and Company
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-Day Person Time Analysis Risk of NAION Associated With PDE5 Inhibitor Use | 30 days prior to NAION onset | Total participant days of PDE5 inhibitor exposure within 30 days prior to onset of NAION. |
Countries
United States
Participant flow
Pre-assignment details
Study Set were enrolled participants who met inclusion/exclusion criteria and physician-diagnosed Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)known date of onset. Adjudication-Confirmed NAION Set were confirmed participants (by adjudication committee) with inclusion/exclusion criteria and physician-diagnosed NAION known date of onset.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 Participants with NAION who have used PDE5 inhibitors | 279 |
| Total | 279 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Information Not Available | 5 |
| Overall Study | No Information on Index Date of Onset | 1 |
| Overall Study | Physician Decision | 4 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Cohort 1 |
|---|---|
| Adjudicated NAION Participants within the 30-Day Analysis Set | 24 Participants |
| Age, Customized | 61.5 years STANDARD_DEVIATION 10.7 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 267 Participants |
| Race/Ethnicity, Customized More than one race | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 5 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 11 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 265 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 3 Participants |
| Region of Enrollment United States | 279 Participants |
| Sex/Gender, Customized Female | 0 Participants |
| Sex/Gender, Customized Male | 279 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 345 |
| serious Total, serious adverse events | 0 / 345 |
Outcome results
Primary
30-Day Person Time Analysis Risk of NAION Associated With PDE5 Inhibitor Use
Total participant days of PDE5 inhibitor exposure within 30 days prior to onset of NAION.
Time frame: 30 days prior to NAION onset
Population: All participants in the 30 day analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | 30-Day Person Time Analysis Risk of NAION Associated With PDE5 Inhibitor Use | 2.27 Relative risk of exposure |