A Study of the Incidence of Intraocular Inflammation and Suspected Endophthalmitis Among Patients Treated With Aflibercept, Vial and Pre-filled Syringe, 2014-2022

Regeneron Pharmaceuticals

Status: Completed

Conditions: Intraocular Inflammation; Suspected Endophthalmitis

Treatments: Other: Non Applicable

Study type: Observational

Funder types: Industry

Identifiers

NCT05791695

VGFTe-OD-2222

Details and patient eligibility

About

Specific study objectives include:

• To describe patient and provider characteristics for aflibercept patients and aflibercept user injections by aflibercept dispensing device, overall, and stratified by time (quarterly, annually).
• To estimate the annual and quarterly incidence of intraocular inflammation (IOI) and suspected endophthalmitis for aflibercept user injections by aflibercept dispensing device.

Secondary objectives

• To estimate the annual incidence of IOI and suspected endophthalmitis for aflibercept user injections by dispensing device, stratified by indication for use, history of IOI, and provider characteristics.

Full description

This study is entirely descriptive using secondary data from the Vestrum Health Retina Treatment and Outcomes database.

Enrollment: 155,413 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for a Treatment Episode:

1. Must have received one or more injections of aflibercept, regardless of indication, between 01Jan2014 to 30Apr2022
2. Patients must have at least one eligible treatment episode a. Specification of laterality of aflibercept injection (left or right eye or both) for treatment episode

Exclusion Criteria for a Treatment Episode:

1. A post-operative follow-up visit for any ocular surgery (excluding vitrectomy), within +/-28 days of aflibercept injection, as defined in the protocol
2. Active steroid treatment, defined as steroid treatment (topical or intravitreal) on the date of aflibercept injection. This criterion is limited to date of aflibercept injection since steroids may be used to treat IOIs.
3. Any treatment episode where a patient eye receives >1 (or an unknown) anti-VEGF injection on the index date (date of aflibercept injection).

Trial design

155,413 participants in 1 patient group

Study Patients

Description:

Patients ≥ 18 years who have received one or more injections of aflibercept during the study period

Treatment:

Other: Non Applicable