NCT05791695

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 155,413 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Intraocular Inflammation
• Suspected Endophthalmitis

Interventions

Type	Name	Description
OTHER	Non Applicable	No study-specific interventions for this observational study.

Timeline

• Start date: 2022-09-16
• Primary completion: 2022-12-30
• Completion: 2023-09-15
• First posted: 2023-03-30
• Last updated: 2023-12-01

Locations

1 site across 1 country: United States