Status: Ongoing First registered on: 31/07/2019
Last updated on: 27/10/2020
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 
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