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

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (S01LA05) aflibercept

  aflibercept

Population studied

• Short description of the study population:
  Physicians and patients with recent aflibercept experience in a total of up to five European countries (the United Kingdom, Germany, France, Spain, and Italy).
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  1250

Study design details

• Main study objective:
  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.
• Outcomes:
  1) Knowledge and understanding among physicians regarding key safety information contained in the educational materials: the prescriber guide and video2) 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.
• Data analysis plan:
  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.