Efetividade de Materiais Educacionais para Profissionais de Saúde e População geral Alvo enquanto Medidas Adicionais de Minimização de Risco para Vabysmo®, Eylea® e Lucentis® - O Estudo MARVEL

21/09/2023
21/09/2023
EU PAS number:
EUPAS106809
Study
Planned
Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cohort
Population studied

Age groups

  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)

Estimated number of subjects

500
Study design details

Main study objective

The objective of the study is to evaluate the effectiveness of educational materials designed to healthcare professionals and patients used as additional risk minimisation measures for Vabysmo® (faricimab), Eylea® (aflibercept) and Lucentis® (ranibizumab).

Outcomes

For healthcare professionals and the general population target, evaluate: - Receiving and viewing educational materials used as additional risk minimisation measures for Vabysmo® (faricimab), Eylea® (aflibercept) and Lucentis® (ranibizumab). - The level of knowledge of the key messages described in the educational materials used as additional risk minimisation measures for Vabysmo® (faricimab), Eylea® (aflibercept) and Lucentis® (ranibizumab).

Data analysis plan

Descriptive statistics will be used. Frequency distributions with 95% confidence intervals (CI) will be calculated for all responses. The data will be stratified by target group: health care professionals and patients/caregivers and by medicine.