Macular DegenerationNCT02615496
Evaluation of Physician and Patient Knowledge of Safety and Safe Use Information for Aflibercept
An observational study of Macular Degeneration, run by Bayer at 5 sites in 5 countries.
Trial summary
The study will be an observational, cross-sectional study of knowledge, understanding, and self-reported behavior among a sample of physicians and patients with recent aflibercept experience in a total of up to five European countries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 716 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 7 Dec 2015to 31 Jan 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Physicians eligible to participate will be ophthalmologists who have administered aflibercept in the past 6 months. Patients eligible to participate will be those who have already received at least one aflibercept injection and are returning for a subsequent visit. Patients will be aged 18 years or older, and will be able to understand the native language of the country in which the study is conducted.
Who may be able to join
- Physicians eligibility:
- Licensed and practicing ophthalmologist
- Prescribed and administered aflibercept to at least one patient in the past 6 months
- Patients eligibility:
- Patient has been administered aflibercept at least once within the last 6 months for any indication and is returning for a subsequent visit.
- Patient is aged 18 years or older.
Show all 9Show fewer
- Patient is able to understand and sign the consent form and patient questionnaire.
- Patient can understand the native language of the country in which the study is being conducted.
- Patient has not participated in a clinical trial for the treatment of an aflibercept indication (e.g., wAMD, CRVO, or DME) in the past 12 months.
Who cannot join
None listed.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: Evaluation of Physician and Patient Knowledge of Safety and Safe Use Information for Aflibercept in Europe: An Observational Postauthorisation Study
The study will be an observational, cross-sectional study of knowledge, understanding, and self-reported behavior among a sample of physicians and patients with recent aflibercept experience in a total of up to five European countries.
- Conditions
- Macular Degeneration
- Being tested
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- Keywords
- Health Care Surveys, Vascular Endothelial Growth Factor
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)Behavioural
Survey to measure physician awareness and understanding of the key messages in the educational materials: the prescriber guide and video.
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)Behavioural
Survey to measure patient awareness and understanding of the key messages in the educational materials: the patient booklet "Your guide to EYLEA," patient information leaflet, and audio CD.
| Study group | Role | What they receive |
|---|---|---|
| Educational materials: Physicians | Not described Receives: Behavioral: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) | |
| Educational materials: Patients | Not described Receives: Behavioral: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of physicians with accurate knowledge and understanding of key safety information (identified risks and prescribing behaviors) contained in the Eylea educational materials as assessed by a study specific questionnaire.
Measured: Up to 2 years
The proportion of patients with accurate knowledge and understanding of key safety information (identified risks and guidelines) contained in the Eylea educational materials as assessed by a study specific interviewer administered questionnaire.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study start7 Dec 2015
- Primary completion30 Sep 2016
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies 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
- 716 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RTI Health Solutions
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615496
- Sponsor's protocol ID
- 16526
- Other IDs
- EY1301
- Status last verified
- Sep 2017
- First submitted
- 21 Oct 2015
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Physician and Patient Knowledge of Safety and Safe Use Information for Aflibercept in Europe: An Observational Postauthorisation Study
- ClinicalTrials.gov ID
- NCT02615496
- Acronym / sponsor ID
- 16526
- Conditions
- Macular Degeneration
- Keywords
- Health Care Surveys, Vascular Endothelial Growth Factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 716 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- RTI Health Solutions
- Study start
- 7 Dec 2015 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 26 Nov 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 study will be an observational, cross-sectional study of knowledge, understanding, and self-reported behavior among a sample of physicians and patients with recent aflibercept experience in a total of up to five European countries.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational materials: Physicians | – | Behavioral: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) |
| Educational materials: Patients | – | Behavioral: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Physicians eligible to participate will be ophthalmologists who have administered aflibercept in the past 6 months. Patients eligible to participate will be those who have already received at least one aflibercept injection and are returning for a subsequent visit. Patients will be aged 18 years or older, and will be able to understand the native language of the country in which the study is conducted.
Key inclusion criteria (9 listed)
- Licensed and practicing ophthalmologist
- Prescribed and administered aflibercept to at least one patient in the past 6 months
- Patient has been administered aflibercept at least once within the last 6 months for any indication and is returning for a subsequent visit.
- Patient is aged 18 years or older.
- Patient is able to understand and sign the consent form and patient questionnaire.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)Survey to measure physician awareness and understanding of the key messages in the educational materials: the prescriber guide and video. | Behavioural | Educational materials: Physicians |
| Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)Survey to measure patient awareness and understanding of the key messages in the educational materials: the patient booklet "Your guide to EYLEA," patient information leaflet, and audio CD. | Behavioural | Educational materials: Patients |
Primary outcome
The proportion of physicians with accurate knowledge and understanding of key safety information (identified risks and prescribing behaviors) contained in the Eylea educational materials as assessed by a study specific questionnaire.
Time frame: Up to 2 years
The proportion of patients with accurate knowledge and understanding of key safety information (identified risks and guidelines) contained in the Eylea educational materials as assessed by a study specific interviewer administered questionnaire.
Time frame: Up to 2 years
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 15 Sep 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
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Degeneration, run by Bayer at 5 sites in 5 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 9 inclusion and 0 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 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Germany, Italy, Spain, United Kingdom. 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?
The proportion of physicians with accurate knowledge and understanding of key safety information (identified risks and prescribing behaviors) contained in the Eylea educational materials as assessed by a study specific questionnaire. (time frame: Up to 2 years). The study lists 2 primary outcomes in all. 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 15 Sep 2017.