Incidence of Central Retinal Artery Occlusion in the Neovascular Age-related Macular Degeneration Population (RAO in neovascular AMD)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Retinal artery occlusion

  Age-related macular degeneration
• Additional medical condition(s):
  Specifically neovascular age-related macular degeneration

Population studied

• Short description of the study population:
  The study included age-related macular degeneration (nAMD) population assessed annually from 2000 to 2018 identified from the IMRD-UK (formerly known as THIN) database.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with retinal artery occlusion and age-related macular degeneration
• Estimated number of subjects:
  5000

Study design details

• Main study objective:
  To establish the incidence of recorded central Retinal Artery Occlusion in the general (IMRD-UK) population stratified by age, sex and smoking status.
• Outcomes:
  Central Retinal Artery Occlusion, Other Retinal Artery Occlusion
• Data analysis plan:
  Incidence rates will be calculated as the number of incident cases of RAO divided by the total population follow up time and is described as the event rate per 100,000 person years (PY). This will be stratified by age category, sex and smoking status. To allow comparison with previous incidence studies, incidence rates will be applied to the 1976 European reference population. To establish the expected event rate in the nAMD population, event rates will be applied to the nAMD population stratified by age & sex, and age, sex & smoking status. Confidence intervals for all standardised incidence rates will be calculated using the approach of Greenland et al (Introduction to Stratified Analysis. In Modern Epidemiology). The actual rate of cRAO in the nAMD population will be calculated as the incidence number of cases divided by the patient years at risk during follow-up, although it is anticipated numbers will be low.

Documents

Study results

EMA report on Aflibercept - EYLEA - Retinal artery occlusion