Cohort study to quantify the risk of glaucoma with intravitreal VEGF inhibitors (bevacizumab, ranibizumab, aflibercept)

Study type

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

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L01XX44) aflibercept

  aflibercept

  (L01XC07) bevacizumab

  bevacizumab

  (S01LA04) ranibizumab

  ranibizumab
• Medical condition to be studied:
  Glaucoma

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:
  What is the risk of glaucoma surgery among non-diabetic new users of anti-VEGF drugs for ocular diseases in Tuscany, Italy, compared across brands?
• Outcomes:
  risk of glaucoma surgery, risk of glaucoma diagnosis
• Data analysis plan:
  Descriptive statistics: i.e number of users of bevacizumab, ranibizumab, aflibercept in the study population. Mean age by different drugs. Compute covariate distributions (age, gender by drug type). Average number of injection during follow-up for all three drugs. Crude number of outcomes (glaucoma surgeries and glaucoma outcome) by different exposure strata Cox regression to compute Hazard ratios: First, perform an intention to treat analysis i.e exposure is defined as index drug based on the first injection (‘Time on’) followed forward to an event (outcome 1 or 2) or censored based on above criteria. Adjustment: Age, use of oral corticosteroids, gender, comorbidities, binocularity.