Anterior Ischemic Optic NeuropathyPhase 4NCT00867815
PDE5 Inhibitor Use and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
A Phase 4 study testing Diagnostic procedures in people with Anterior Ischemic Optic Neuropathy, run by Bayer at 13 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Anterior Ischemic Optic Neuropathy
- What is being tested?
- Diagnostic procedures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 13 Jul 2009to 28 Mar 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of multiple sclerosis or optic neuritis
- Evidence of temporal arteritis
- History of vasculitis or collagen vascular disease
- Previous history of NAION
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
United States11 sites
Asheville Eye Associates
Asheville, North Carolina, 28803
Palm Beach Eye Center
Atlantis, Florida, 33461
Office of Dr. Avrom Epstein, MD
Columbus, Ohio, 43215-7312
West Coast Eye Care
Fort Myers, Florida, 33908
National Ophthalmic Research Institute
Fort Myers, Florida, 33912
Retinal and Ophthalmic Consultants
Houston, Texas, 77030
Midwest Eye Institute
Indianapolis, Indiana, 46290
Sarasota Retina Institute
Sarasota, Florida, 34239
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, 74014
Greider Eye Associates
Vista, California, 92083
Spoor and Associates
Warren, Michigan, 48088
About this study
Official title: Prospective Case Crossover Study to Assess Whether PDE5 Inhibitor Exposure in Men Increases the Risk for the Development of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
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.
Read the detailed description
Collected data will be compared to historic data of the same participant in case-crossover design.
- Conditions
- Anterior Ischemic Optic Neuropathy
- Being tested
- Diagnostic procedures
- 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.
- Medical subject headings
- Optic Neuropathy, Ischemic, Blindness, Vision Disorders, Optic Nerve Diseases, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic proceduresDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Drug: Diagnostic procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 45 days prior to study enrollment
Secondary outcomes (2)
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.
Measured: Day 1
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.
Measured: From informed consent signed up to Visit 2 (Day 90+/-30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study start13 Jul 2009
- Primary completion29 Dec 2017
- Study completion28 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anterior Ischemic Optic NeuropathyStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867815
- Sponsor's protocol ID
- 12912
- Other IDs
- 2010-023586-22
- Status last verified
- Jan 2019
- First submitted
- 23 Mar 2009
- Last updated
- 23 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Case Crossover Study to Assess Whether PDE5 Inhibitor Exposure in Men Increases the Risk for the Development of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
- ClinicalTrials.gov ID
- NCT00867815
- Acronym / sponsor ID
- 12912
- Conditions
- Anterior Ischemic Optic Neuropathy
- Keywords
- Non-arteritic Anterior Ischemic Optic Neuropathy, NAION, PDE5 inhibitors, vardenafil, Levitra, sildenafil, Viagra, Tadalafil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2009 (actual)
- Primary completion
- 29 Dec 2017 (actual)
- Study completion
- 28 Mar 2018 (actual)
- First posted
- 24 Mar 2009 (estimated)
- Results
- Posted 23 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Drug: Diagnostic procedures |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- History of multiple sclerosis or optic neuritis
- Evidence of temporal arteritis
- History of vasculitis or collagen vascular disease
- Previous history of NAION
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic proceduresThe patients will not receive any study drug in this study. The patients will have ophthalmological (eye) examinations, blood work and will complete an interview | Drug | Arm 1 |
Primary outcome
Number of Participants With Confirmed Diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Time frame: 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.
2 secondary outcomes
Number of Participants With Most Frequent Medical History Findings by Primary System Organ Class at Visit 1
Time frame: Day 1
Number of Participants With Any Adverse Events Reported at Visit 2
Time frame: From informed consent signed up to Visit 2 (Day 90+/-30)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diagnostic procedures in people with Anterior Ischemic Optic Neuropathy, run by Bayer at 13 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Confirmed Diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) (time frame: Up to 45 days prior to study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.