1. Study identification
EU PAS Register NumberEUPAS30727
Official titleEvaluation of Physician Knowledge of Safety and Safe Use Information for Aflibercept Administered by Intravitreal Injection in Europe: A Follow-up Physician Survey
Study title acronym
Study typeObservational study
Brief description of the studyThe study will be an observational, cross-sectional study of knowledge, understanding, and self-reported behavior among a sample of physicians with recent aflibercept experience in a total of up to 5 European countries. Physicians from a physician panel will be invited to complete a brief web-based structured questionnaire regarding their knowledge of key safety information in the aflibercept educational materials.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)?
EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Details of (Primary) lead investigator
Title Dr
Last name BAYER AG
First name Bayer Clinical Trials
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
International study
France
Germany
Italy
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed22/03/2019
Start date of data collection01/10/201908/10/2019
Start date of data analysis
Date of interim report, if expected
Date of final study report01/12/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBayer AG100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name BAYER AG
First name Bayer Clinical Trials
Address line 1Muellerstrasse 178
Address line 2
Address line 3
CityBerlin
Postcode13342
CountryGermany
Phone number (incl. country code)49-30300139005
Alternative phone number
Fax number (incl. country code)34937608507
Public Enquiries
Title Dr
Last name BAYER AG
First name Bayer Clinical Trials
Address line 1Muellerstrasse 178
Address line 2
Address line 3
CityBerlin
Postcode13342
CountryGermany
Phone number (incl. country code)49-30300139005
Alternative phone number
Fax number (incl. country code)34937608507
11. Scope of the study
What is the scope of the study?
Effectiveness evaluation
Evaluation of effectiveness of risk minimization measures
Primary scope : Effectiveness evaluation
12. Main objective(s)
What is the main objective of the study?
Measure physician knowledge and understanding of the key information in the revised educational material, with particular focus on knowledge of concepts that were of key concern in the previous survey
Are there primary outcomes?Yes
Percentage of physicians responding correctly to each individual knowledge question
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Cross-sectional study
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
The analyses will be descriptive in nature and will include detailed review of responses to individual questions and potential summary measures across logical grouping of response items.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted