An Observational, Prospective Post-Marketing Surveillance Program to Evaluate theSafety Profile of Intravitreal Ozurdex® in the Treatment of Visual Impairment due to Diabetic Macular Edema by Actively Identifying and Evaluating the Occurrence of Adverse Events and Serious Adverse Events information

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
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  OZURDEX
• Medical condition to be studied:
  Macular oedema

Population studied

• Short description of the study population:
  Adult subjects who were scheduled to receive at least one intravitreal Ozurdex® injection for the treatment of visual impairment due to diabetic macular edema.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with diabetic macular oedema
• Estimated number of subjects:
  250

Study design details

• Main study objective:
  To evaluate the safety profile of Ozurdex® by actively identifying and evaluating the occurrence of AEs and serious adverse events (SAEs) for 1 year period in adult Indian patients (≥18 years of age) who will be receiving at least one intravitreal Ozurdex® injection for the treatment of visual impairment due to DME.
• Data analysis plan:
  For continuous data, number of non-missing records, mean, standard deviation, median, minimum, maximum and the two-sided 95% confidence interval (CI) of the mean will be presented. For categorical data, number of non-missing records and percentages will be presented. Frequency of AE/SAEs among the study participants during the study period will be calculated if applicable.