Evaluation of Physician Knowledge of Safety and Safe Use Information for Aflibercept Administered by Intravitreal Injection in Europe: A Follow-up Physician Survey

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)
• 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
• Medical condition to be studied:
  Macular degeneration

Population studied

• Short description of the study population:
  This study will be conducted with physicians (ophthalmologists) who prescribe and/or administer aflibercept in the target countries.; ; Eligibility criteria; • Has signed informed consent; • Is a licensed and practicing ophthalmologist; • Has prescribed and/or administered aflibercept to at least one patient in the past 6 months
• 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:
  400

Study design details

• Main study objective:
  Measure physician knowledge and understanding of the key information in the revised educational material, with particular focus on knowledge of concepts that were of key concern in the previous survey
• Outcomes:
  Percentage of physicians responding correctly to each individual knowledge question
• Data analysis plan:
  The analyses will be descriptive in nature and will include detailed review of responses to individual questions and potential summary measures across logical grouping of response items.

Documents

Study results

20285_EU PAS Abstract_Redacted_V1.0_2021-04-06

Study report

20285_CSR_V1.0_2020-08-21_Redacted