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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/23134
• EU PAS number:
  EUPAS9991
• Study ID:
  23134
• Official title and acronym:
  Evaluation of Physician and Patient Knowledge of Safety and Safe Use Information for Aflibercept in Europe: An Observational Postauthorisation Study
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  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 status:
  Finalised

Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

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

Study timelines

Date when funding contract was signed

Planned: 20/06/2013

Actual: 20/06/2013

Study start date

Planned: 01/12/2015

Actual: 07/12/2015

Date of final study report

Planned: 15/03/2017

Actual: 05/06/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer Pharma AG

Study protocol

Initial protocol

EM_Protocol_Final after EMA review_v3_11 Feb 2015ENCePP

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)