Anterior Ischemic Optic Neuropathy
Conditions
Keywords
Non-arteritic Anterior Ischemic Optic Neuropathy, NAION, PDE5 inhibitors, vardenafil, Levitra, sildenafil, Viagra, Tadalafil, Cialis, acute vision loss, vision loss, blurred vision, optic neuropathy, erectile dysfunction.
Brief summary
The primary objective of this study is to determine whether the use of PDE5 inhibitors (vardenafil, sildenafil, or tadalafil) increases the risk for the development of NAION.
Detailed description
Collected data will be compared to historic data of the same participant in case-crossover design.
Interventions
The patients will not receive any study drug in this study. The patients will have ophthalmological (eye) examinations, blood work and will complete an interview
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* NAION onset within 45 days before entry to the study * NAION onset definable by the subject within a 2 calendar day window * Men who have taken at least 1 dose of PDE5 inhibitor(s) at any time in the 1 year prior to enrollment in the study * Age 40 years or older
Exclusion criteria
* History of multiple sclerosis or optic neuritis * Evidence of temporal arteritis * History of vasculitis or collagen vascular disease * Previous history of NAION
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Confirmed Diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) | Up to 45 days prior to study enrollment | The study population consisted of adult men, first diagnosed with NAION which started within 45 days before study start and took PDE5 inhibitors (vardenafil, sildenafil, tadalafil or avanafil) in the 1 year prior to enrollment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Most Frequent Medical History Findings by Primary System Organ Class at Visit 1 | Day 1 | The safety population includes participants who signed informed consent and who had any of the following collected at Visit 1 for safety: laboratory values, physical exam, any eye exams, or adverse events. |
| Number of Participants With Any Adverse Events Reported at Visit 2 | From informed consent signed up to Visit 2 (Day 90+/-30) | An adverse event is any untoward medical occurrence in a subject or clinical investigation subject and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally occurring during the trial. |
Countries
Australia, Canada, United States
Participant flow
Recruitment details
The study started on 13 JUL 2009 (FPFV) and the date of last visit was 29 DEC 2017 (LPLV).
Pre-assignment details
There were 10 screening failures. The primary reasons for screen failure are protocol violation (8 participants) and consent withdrawn (2 participants)
Participants by arm
| Arm | Count |
|---|---|
| PDE5 Inhibitor Use & Risk of NAION Participants were assessed at 2 visits. Visit 1 (Day 1) included screening, confirmation of the diagnosis of NAION, enrollment, and collection of data on PDE5 inhibitor and other concomitant medication use. Visit 2 (Day 90+/-30) was a follow-up visit to document the persistence of vision loss and confirm the diagnosis of NAION. No interventional treatment was administered in the context of this study. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | PDE5 Inhibitor Use & Risk of NAION |
|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 11.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 2 / 10 |
| serious Total, serious adverse events | 1 / 10 |
Outcome results
Primary
Number of Participants With Confirmed Diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
The study population consisted of adult men, first diagnosed with NAION which started within 45 days before study start and took PDE5 inhibitors (vardenafil, sildenafil, tadalafil or avanafil) in the 1 year prior to enrollment.
Time frame: Up to 45 days prior to study enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PDE5 Inhibitor Use & Risk of NAION | Number of Participants With Confirmed Diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) | 10 Participants |
Secondary
Number of Participants With Any Adverse Events Reported at Visit 2
An adverse event is any untoward medical occurrence in a subject or clinical investigation subject and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally occurring during the trial.
Time frame: From informed consent signed up to Visit 2 (Day 90+/-30)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PDE5 Inhibitor Use & Risk of NAION | Number of Participants With Any Adverse Events Reported at Visit 2 | 3 Participants |
Secondary
Number of Participants With Most Frequent Medical History Findings by Primary System Organ Class at Visit 1
The safety population includes participants who signed informed consent and who had any of the following collected at Visit 1 for safety: laboratory values, physical exam, any eye exams, or adverse events.
Time frame: Day 1
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PDE5 Inhibitor Use & Risk of NAION | Number of Participants With Most Frequent Medical History Findings by Primary System Organ Class at Visit 1 | Metabolism and nutrition disorders | 7 Participants |
| PDE5 Inhibitor Use & Risk of NAION | Number of Participants With Most Frequent Medical History Findings by Primary System Organ Class at Visit 1 | Eye disorders | 6 Participants |