Incidence of Retinal Vasculitis With or Without Retinal Vascular Occlusion Among Eyes Treated With Approved Anti-Vascular Endothelial Growth Factor Agents in Neovascular Age-Related Macular Degeneration or Diabetic Macular Edema

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  AVASTIN

  BEOVU

  BYOOVIZ

  EYLEA

  LUCENTIS

  VABYSMO
• Name of medicine, other:
  Cimerli
• Study drug International non-proprietary name (INN) or common name:
  AFLIBERCEPT

  BEVACIZUMAB

  BROLUCIZUMAB

  FARICIMAB

  RANIBIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (S01LA04) ranibizumab

  ranibizumab

  (S01LA05) aflibercept

  aflibercept

  (S01LA06) brolucizumab

  brolucizumab

  (S01LA08) bevacizumab

  bevacizumab

  (S01LA09) faricimab

  faricimab
• Medical condition to be studied:
  Neovascular age-related macular degeneration

  Diabetic retinopathy
• Additional medical condition(s):
  Diabetic macular edema

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:
  250000

Study design details

• Main study objective:
  Assess and compare the incidence of RV, RV with RO, and IOI (including RV) with RO events across eyes treated with approved IVT anti-VEGF agents after diagnosis of nAMD or DME as recorded in the EHR database.
• Setting:
  The study will include patient eyes from the Vestrum Health database, which includes data from EHRs from private retina specialists in the United States. Diagnosis of nAMD, DME, and AEs will be identified using ICD-9/10-CM diagnosis codes. Eyes not coming from active practices in the Vestrum database will not be included. Although Vestrum Health data are available from 1 January 2014, the appropriate study period will be determined based on the amount of data accrued across all treatment agents of interest, taking into consideration any potential surveillance or reporting bias such as that due to increased awareness of these events following brolucizumab launch.
• Outcomes:
  - Incidence of RV, RV with RO, and IOI (including RV) with RO events across eyes treated with approved IVT anti-VEGF agents after diagnosis of nAMD or DME; ; - Summarize the demographic and clinical characteristics of study eyes;; - Among eyes with events, summarize the characteristics of anti-VEGF treatments received, including but not limited to the number of injections received, type of anti-VEGF agents received, time to event, and vision change and severe vision loss following the event
• Data analysis plan:
  The primary analyses involve identifying the occurrence of the following adverse events: RV, RV with RO, and IOI (including RV) with RO among eyes with nAMD or DME. Eyes with each retinal indication and event will be identified using ICD-9/10-CM codes. Among eyes with multiple indications, eyes will be assigned to the first retinal indication diagnosed. The incidence of RV, RV with RO, IOI (including RV) with RO may be summarized using n (%) patient eyes at risk with events, the number of events per 1,000 injections (or 10,000 injections, etc. as appropriate), or the incidence rate (number of events/eye-time). The relative risk of RV, RV with RO, and IOI (including RV) with RO events by different anti-VEGF agents compared to a reference agent will be calculated.