Trial Outcomes & Findings for PDE5 Inhibitor Use and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) (NCT NCT00867815)

Last Updated: 2019-01-23

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

Up to 45 days prior to study enrollment

Results posted on

2019-01-23

Participant Flow

The study started on 13 JUL 2009 (FPFV) and the date of last visit was 29 DEC 2017 (LPLV).

There were 10 screening failures. The primary reasons for screen failure are protocol violation (8 participants) and consent withdrawn (2 participants)

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	1

Baseline Characteristics

PDE5 Inhibitor Use and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PDE5 Inhibitor Use & Risk of NAION n=10 Participants 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.
Age, Continuous	62.3 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 45 days prior to study enrollment

Outcome measures

Outcome measures
Measure	PDE5 Inhibitor Use & Risk of NAION n=10 Participants 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.
Number of Participants With Confirmed Diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)	10 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PDE5 Inhibitor Use & Risk of NAION n=10 Participants 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.
Number of Participants With Most Frequent Medical History Findings by Primary System Organ Class at Visit 1 Metabolism and nutrition disorders	7 Participants
Number of Participants With Most Frequent Medical History Findings by Primary System Organ Class at Visit 1 Eye disorders	6 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PDE5 Inhibitor Use & Risk of NAION n=10 Participants 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.
Number of Participants With Any Adverse Events Reported at Visit 2	3 Participants

Adverse Events

PDE5 Inhibitor Use & Risk of NAION

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PDE5 Inhibitor Use & Risk of NAION n=10 participants at risk 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.
Eye disorders Optic ischaemic neuropathy	10.0% 1/10 • Number of events 1 • From inform consent signed up to approximately 3 months after first diagnosis of NAION

Other adverse events

Other adverse events
Measure	PDE5 Inhibitor Use & Risk of NAION n=10 participants at risk 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.
Eye disorders Eye irritation	10.0% 1/10 • Number of events 1 • From inform consent signed up to approximately 3 months after first diagnosis of NAION
Eye disorders Ocular discomfort	10.0% 1/10 • Number of events 1 • From inform consent signed up to approximately 3 months after first diagnosis of NAION

Additional Information

Therapeutic Area Head

Bayer

Phone: (+) 1-888-8422937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The agreed point of publication is 12-18 months after database lock at the earliest. * Bayer will have up to 30/45 days to review publications, and may request an additional publication delay of up to 60 days to allow for filing a Patent Application (if applicable). * No publication of single center data should be done prior of publication if multi -center data)。
Publication restrictions are in place

Restriction type: OTHER