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Status: Finalised First registered on: 19/06/2015

Last updated on: 14/03/2018

1. Study identification

EU PAS Register NumberEUPAS9991

Official titleEvaluation of Physician and Patient Knowledge of Safety and Safe Use Information for Aflibercept in Europe: An Observational Postauthorisation Study

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 and patients with recent aflibercept experience in a total of up to five European countries.

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

Website/Homepagehttps://www.rtihs.org/services/pharmacoepidemiology-and-risk-management

Details of (Primary) lead investigator

Title Dr

Last name Andrews

First name Elizabeth

Is this study being carried out with the collaboration of a research network?

Other centres where this study is being conducted

Multiple centres

In total how many centres are involved in this Study?75

Richard Gale, MD, York Hospital, York, UK

Prof. Sascha Fauser, Univ. of Cologne, Cologne, DE

Joel Uzzan, MD, Clinique Mathilde, Rouen, FR

Prof F. Semeraro, Univ. of Brescia, Brescia, IT

Dr. Joan Escobar, Centre d’ Atencio, Barcelona, SP

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 signed20/06/201320/06/2013

Start date of data collection01/12/201507/12/2015

Start date of data analysis

Date of interim report, if expected

Date of final study report15/03/201705/06/2017

4. Sources of funding

Please provide estimates of the percentage of funding by source for this study

Names(s)Approximate % funding

Pharmaceutical companiesBayer Pharma AG100

Charities

Government body

Research councils

EU funding scheme

5. Contact details for enquiries

Scientific Enquiries

Title Dr

Last name Andrews

First name Elizabeth

Address line 1RTI-Health Solutions

Address line 2200 Park Offices Drive

Address line 3

CityResearch Triangle Park, NC 27709

Postcode

CountryUnited States

Phone number (incl. country code)01-9195415819

Alternative phone number

Fax number (incl. country code)

Email address eandrews@rti.org

Public Enquiries

Title Dr

Last name Bayer HealthCare AG

First name Bayer Pharma AG

Address line 1CTP Team / Ref:"EU CTR"/

Address line 2Bayer Pharma AG

Address line 3

CityBerlin

Postcode

CountryGermany

Phone number (incl. country code)49-30300139005

Alternative phone number

Fax number (incl. country code)

Email address clinical-trials-contact@bayerhealthcare.com

11. Scope of the study

What is the scope of the study?

Evaluation of effectiveness of risk minimization measures

Primary scope : Evaluation of effectiveness of risk minimization measures

12. Main objective(s)

What is the main objective of the study?

The primary objective of this study is to measure physician and patient knowledge and understanding of the key information contained in the aflibercept educational materials: the prescriber guide and video, and the patient booklet “Your guide to EYLEA,” patient information leaflet, and audio CD.

Are there primary outcomes?Yes

1) Knowledge and understanding among physicians regarding key safety information contained in the educational materials: the prescriber guide and video 2) Knowledge and understanding among patients regarding key safety information contained in the educational materials: the patient booklet “Your guide to EYLEA,” patient information leaflet, and audio CD.

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

Analyses will include detailed review of responses to individual questions as well as potential summary measure across logical grouping of response items. Physician results will be stratified by country and other logical variables. Patient results will be stratified by country and other logical variables, potentially including a measure of the knowledge level of their physician. A detailed analysis plan describing methods of analysis and presentation and including table shells will be developed before analysis of data is initiated. In addition to a description of the analysis of the questionnaire data, the analysis plan will describe any planned comparisons of participants and non-participants.