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

Regeneron Pharmaceuticals

Status: Completed

Conditions: Retinal Vasculitis

Treatments: Drug: aflibercept 2mg

Study type: Observational

Funder types: Industry

Identifiers

NCT07105228

VGFTe-OD-2458

Details and patient eligibility

About

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.

Full description

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

Enrollment: 290,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

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 on the injection date will be excluded
3. Patient-eyes with a diagnosis of RV in the same eye as the aflibercept injection or with 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 injection administered on the same date

NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply

Trial design

290,000 participants in 1 patient group

Study Patients

Description:

Patients ≥ 18 years of age, who received aflibercept 2mg IVT during the study period

Treatment:

Drug: aflibercept 2mg