Incidence of Retinal Vasculitis Among Patients Receiving Aflibercept: A US Real-World Evidence Study

Last updated: October 9, 2025
Sponsor: Regeneron Pharmaceuticals
Overall Status: Completed

Phase

N/A

Condition

Dermatomyositis (Connective Tissue Disease)

Diabetic Retinopathy

Lupus

Treatment

aflibercept 2mg

Clinical Study ID

NCT07105228
VGFTe-OD-2458
  • Ages > 18
  • All Genders

Study Summary

This study will describe and estimate the incidence of Retinal Vasculitis (RV) events among patients and patient eyes receiving aflibercept intravitreal (IVT) (Eylea®, aflibercept 2mg) therapy in US clinical practice.

The main objective is to describe demographic and clinical characteristics of patients receiving aflibercept 2mg injections, to estimate the incidence of RV and RV plus Intraocular Inflammation (IOI) following aflibercept 2mg injections and to describe characteristics of RV cases.

Eligibility Criteria

Inclusion

Inclusion Criteria for Patient Population:

  1. All aflibercept injections identified by the Healthcare Common Procedure Coding System (HCPCS) or National Drug Code (NDC) from January 1, 2017, to February 29, 2024, as recorded in the Komodo close claims database.

Exclusion

Key Exclusion Criteria:

  1. Aflibercept injections with unspecified laterality will be excluded

  2. Aflibercept injections from individuals aged <18 years or those with unknown age onthe injection date will be excluded

  3. Patient-eyes with a diagnosis of RV in the same eye as the aflibercept injection orwith unspecified laterality within 12 months (365 days) prior to index date (inclusive), as defined in the protocol

  4. Patient-eyes that do not meet the continuous enrollment requirement will be excluded

  5. Aflibercept injections will be excluded if there is ≥1 other anti-VEGF injectionadministered on the same date

NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply

Study Design

Total Participants: 290000
Treatment Group(s): 1
Primary Treatment: aflibercept 2mg
Phase:
Study Start date:
July 15, 2025
Estimated Completion Date:
September 15, 2025

Study Description

This study is purely descriptive using US claims data from Komodo Healthcare Map.

Connect with a study center

  • Regeneron Research Site

    Tarrytown, New York 10591
    United States

    Site Not Available

  • Regeneron Research Site

    Tarrytown 5140538, New York 5128638 10591
    United States

    Site Not Available

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