Age-related Macular Degeneration (AMD)NCT02585401
Evaluation of Physician Knowledge of Safety and Safe Use Information for Aflibercept in Canada
An observational study of Age-related Macular Degeneration (AMD) and Central Retinal Vein Occlusion (CRVO), run by Bayer at 1 site in Canada.
Trial summary
The primary objective of this study is to measure physician knowledge and understanding of the key safety information contained in the Eylea vial preparation instruction card, the intravitreal injection procedure video, and the product monograph. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Age-related Macular Degeneration (AMD), Central Retinal Vein Occlusion (CRVO), Diabetic Macular Edema (DME)
- What is being tested?
- Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
- Type of treatment
- Injection or infusion
- How many people
- 99 participants
- Where
- 1 siteCanada
- Study dates
- 18 Feb 2016to 19 May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Physicians prescribing aflibercept in Canada will be selected to reflect the distribution of retinal specialists and ophthalmologists who prescribe aflibercept.
Who may be able to join
- This study will be conducted with retinal specialists and ophthalmologists in Canada who have prescribed and/or administered aflibercept to at least 1 patient in the past 6 months.
Who cannot join
- None applied
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Physician Knowledge of Key Safety Information for Eylea in Canada: An Observational Postauthorization Safety Study
The primary objective of this study is to measure physician knowledge and understanding of the key safety information contained in the Eylea vial preparation instruction card, the intravitreal injection procedure video, and the product monograph.
Read the detailed description
The source of information for the study will be self-reported data collected from physicians using standard questionnaires with closed-ended response choices. Questionnaires for physicians will be developed and tested using best practices for instrument development. The questions will be tailored to the study aims and the information provided in the the vial preparation instruction card, the intravitreal injection procedure video, and the Eylea product monograph.
Other questions will obtain information needed to assess potential differences across subgroups and identify any biases (e.g., demographics, experience with Eylea).
The questionnaire will be tested through cognitive interviews with physicians. Questionnaires will be tested in local languages, to assure that the introductory material, consent forms, and questionnaire items (question stems and response choices) are culturally appropriate and easily and correctly understood by individuals similar to those who will participate
- Conditions
- Age-related Macular Degeneration (AMD), Central Retinal Vein Occlusion (CRVO), Diabetic Macular Edema (DME)
- Being tested
- Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
- Medical subject headings
- Macular Degeneration, Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Drug
The physician questionnaire will contain primarily closed-ended questions (e.g., multiple choice, true/false), with few free-text response fields, eliciting responses measuring physician knowledge and understanding of the key information in the Eylea vial preparation instruction card, the intravitreal injection procedure video, and the product monograph.
| Study group | Role | What they receive |
|---|---|---|
| Eylea product and application information / Cohort 1 | Physicians prescribing aflibercept in Canada will be selected to reflect the distribution of retinal specialists and ophthalmologists who prescribe aflibercept. Receives: Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge and understanding of key information contained in the aflibercept educational materials: the Eylea vial preparation instruction card, the intravitreal injection procedure video, and the product monograph
The source of information for the study will be self-reported data collected from physicians using standard questionnaires with closed-ended response choices.
Measured: Up to 8 weeks after the start of data collection
Secondary outcomes (1)
Investigation whether physicians have received the educational materials
Descriptive results assessing Number and percentage (%) of physicians
Measured: up to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study start18 Feb 2016
- Primary completion31 Mar 2016
- Study completion19 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Macular Degeneration (AMD)Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585401
- Sponsor's protocol ID
- 18498
- Status last verified
- Mar 2017
- First submitted
- 22 Oct 2015
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Physician Knowledge of Key Safety Information for Eylea in Canada: An Observational Postauthorization Safety Study
- ClinicalTrials.gov ID
- NCT02585401
- Acronym / sponsor ID
- 18498
- Conditions
- Age-related Macular Degeneration (AMD), Central Retinal Vein Occlusion (CRVO), Diabetic Macular Edema (DME)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 18 Feb 2016 (actual)
- Primary completion
- 31 Mar 2016 (actual)
- Study completion
- 19 May 2016 (actual)
- First posted
- 23 Oct 2015 (estimated)
- Results
- Not posted in the source record
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 measure physician knowledge and understanding of the key safety information contained in the Eylea vial preparation instruction card, the intravitreal injection procedure video, and the product monograph.
Detailed description
The source of information for the study will be self-reported data collected from physicians using standard questionnaires with closed-ended response choices. Questionnaires for physicians will be developed and tested using best practices for instrument development. The questions will be tailored to the study aims and the information provided in the the vial preparation instruction card, the intravitreal injection procedure video, and the Eylea product monograph.
Other questions will obtain information needed to assess potential differences across subgroups and identify any biases (e.g., demographics, experience with Eylea).
The questionnaire will be tested through cognitive interviews with physicians. Questionnaires will be tested in local languages, to assure that the introductory material, consent forms, and questionnaire items (question stems and response choices) are culturally appropriate and easily and correctly understood by individuals similar to those who will participate
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eylea product and application information / Cohort 1 | – | Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Physicians prescribing aflibercept in Canada will be selected to reflect the distribution of retinal specialists and ophthalmologists who prescribe aflibercept. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Physicians prescribing aflibercept in Canada will be selected to reflect the distribution of retinal specialists and ophthalmologists who prescribe aflibercept.
Key inclusion criteria (1 listed)
- This study will be conducted with retinal specialists and ophthalmologists in Canada who have prescribed and/or administered aflibercept to at least 1 patient in the past 6 months.
Key exclusion criteria (1 listed)
- None applied
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 |
|---|---|---|
| Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)The physician questionnaire will contain primarily closed-ended questions (e.g., multiple choice, true/false), with few free-text response fields, eliciting responses measuring physician knowledge and understanding of the key information in the Eylea vial preparation instruction card, the intravitreal injection procedure video, and the product monograph. | Drug | Eylea product and application information / Cohort 1 |
Primary outcome
Knowledge and understanding of key information contained in the aflibercept educational materials: the Eylea vial preparation instruction card, the intravitreal injection procedure video, and the product monograph
Time frame: Up to 8 weeks after the start of data collection
The source of information for the study will be self-reported data collected from physicians using standard questionnaires with closed-ended response choices.
1 secondary outcome
Investigation whether physicians have received the educational materials
Time frame: up to 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-related Macular Degeneration (AMD) and Central Retinal Vein Occlusion (CRVO), run by Bayer at 1 site in Canada.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Knowledge and understanding of key information contained in the aflibercept educational materials: the Eylea vial preparation instruction card, the intravitreal injection procedure video, and the product monograph (time frame: Up to 8 weeks after the start of data collection). 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 21 Mar 2017.