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

Completed

• Conditions: Suspected Endophthalmitis; Intraocular Inflammation
• Interventions: Other: Non Applicable

• Registration Number: NCT05791695
• Lead Sponsor: Regeneron Pharmaceuticals

Brief 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.

Study Timeline

• Study Start: 2022-09-16
• Primary Completion: 2022-12-30
• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-03-28
• Study First Posted: 2023-03-30
• Study Completion: 2023-09-15
• Status Verified: 2023-10
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155413

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Patients	Non Applicable	Patients ≥ 18 years who have received one or more injections of aflibercept during the study period

Primary Outcome Measures

Name	Time	Method
Incidence of suspected endophthalmitis by ophthalmic delivery mechanism	End of Study, Approximately 8 Years	Incidence will be defined as the number of events during the at-risk period divided by the total number of injections, identified using international classification of diseases (ICD-9 and ICD-10) diagnosis codes.; Ophthalmic delivery mechanism defined as prefilled syringe (PFS) and vial
Frequency of patients receiving aflibercept injections	End of Study, Approximately 8 Years
Frequency of aflibercept injections by ophthalmic delivery mechanism	End of Study, Approximately 8 Years	Ophthalmic delivery mechanism defined as prefilled syringe (PFS) and vial
Incidence of Intraocular inflammation (IOI) by ophthalmic delivery mechanism	End of Study, Approximately 8 Years	Incidence will be defined as the number of events during the at-risk period divided by the total number of injections, identified using international classification of diseases (ICD-9 and ICD-10) diagnosis codes.; Ophthalmic delivery mechanism defined as prefilled syringe (PFS) and vial
Incidence of suspected endophthalmitis	End of Study, Approximately 8 Years	Incidence will be defined as the number of events during the at-risk period divided by the total number of injections, identified using international classification of diseases (ICD-9 and ICD-10) diagnosis codes.
Incidence of Intraocular inflammation (IOI)	End of Study, Approximately 8 Years	Incidence will be defined as the number of events during the at-risk period divided by the total number of injections, identified using international classification of diseases (ICD-9 and ICD-10) diagnosis codes.

Trial Locations

Locations (1)

Regeneron Research Site; 🇺🇸 Tarrytown, New York, United States