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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/107731
• EU PAS number:
  EUPAS107730
• Study ID:
  107731
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is a secondary data use, retrospective observational cohort study. The study will analyze anonymized electronic health record (EHR) data from private retina specialists in the United States to assess the incidence of retinal vasculitis (RV), RV with retinal vascular occlusion (RO), and intraocular inflammation (IOI) (including RV) with RO among eyes with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME). Incidence will be assessed among eyes treated with intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) agents. The EHR (Vestrum Health Database) records longitudinal information on patient diagnosis, treatments, and outcomes, which allows the assessment of incident adverse events (AEs) and the temporality of treatments relative to the AEs. The selected database also contains data on visual acuity (VA), which allows for the assessment of potential vision changes following the occurrence of an AE. Diagnosis of nAMD, DME, and AEs will be identified using International Classification of Diseases 9/10 Clinical Modification (ICD-9/10-CM) diagnosis codes. 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 AEs following brolucizumab launch. Inclusion criteria: eyes diagnosed with nAMD or DME that received at least 1 anti-VEGF treatment during the study period following the date of the index diagnosis; patients who were 18 years or older at the index anti-VEGF treatment; eyes with at least one visit following the index anti-VEGF treatment. Exclusion criteria: eyes with an incident IOI, RV, or RO on or prior to the index anti-VEGF treatment date.
• Study status:
  Ongoing

Research institutions and networks

Institutions

F. Hoffmann-La Roche

Study timelines

Date when funding contract was signed

Actual: 09/10/2023

Study start date

Actual: 20/10/2023

Data analysis start date

Planned: 30/09/2026

Date of final study report

Planned: 30/09/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

F. Hoffmann-La Roche, Ltd.

Study protocol

Initial protocol

Prot CR45271 faricimab v2, Published Output-1_signed_20231206_Redacted.pdf

Updated protocol

Prot CR45271 faricimab v3, Published Output-1_Redacted.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

CR45271