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

Sponsor

Regeneron Pharmaceuticals (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05791695

Collaborator

Bayer (Industry)

155,413

Enrollment

Location

Anticipated Duration (Months)

12995.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intraocular Inflammation Suspected Endophthalmitis	Other: Non Applicable

Detailed Description

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

Study Design

Study Type:

Observational

Actual Enrollment :

155413 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Sep 16, 2022

Actual Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Sep 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Study Patients Patients ≥ 18 years who have received one or more injections of aflibercept during the study period	Other: Non Applicable No study-specific interventions for this observational study.

Arm

Intervention/Treatment

Study Patients

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

Other: Non Applicable

No study-specific interventions for this observational study.

Outcome Measures

Primary Outcome Measures

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) [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) 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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria for a Treatment Episode:

Must have received one or more injections of aflibercept, regardless of indication, between 01Jan2014 to 30Apr2022
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:

A post-operative follow-up visit for any ocular surgery (excluding vitrectomy), within +/-28 days of aflibercept injection, as defined in the protocol
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.
Any treatment episode where a patient eye receives >1 (or an unknown) anti-VEGF injection on the index date (date of aflibercept injection).