Ozurdex® (dexamethasone) Implant Risk Management Plan Injector's Guide Assessment Australia

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Online survey

Study drug and medical condition

• Name of medicine:
  OZURDEX

Population studied

• Short description of the study population:
  Australian Retinal Specialists/Ophthalmologists between 24 November 2017 and 20 December 2017.
• 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:
  20

Study design details

• Main study objective:
  the goal of the survey is to evaluate physicians' comprehension of the key risks related to OZURDEX® injection described in the educational materials.
• Outcomes:
  To evaluate the effectiveness of the education materials and their effectiveness as a measure to reduce all the specified important identified risks.
• Data analysis plan:
  The pass rate as defined in the survey for each individual HCP is a result of at least 80% correct. Therefore, a HCP is defined as passing with 19/23 (approx. 80%) for more correctly answered questions