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

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.

Study Overview

• Status: Completed
• Conditions: Intraocular Inflammation; Suspected Endophthalmitis
• Intervention / Treatment: Other: Non Applicable

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 155413

Contacts and Locations

Study Locations

• United States
  • New York
    • Tarrytown, New York, United States, 10591
      • Regeneron Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study period will span from 01 Jan 2014 (earliest complete data available) to 28 May 2022 (or most current data available). The study will include patients ≥18 years of age in Vestrum who have received one or more injections of aflibercept, regardless of indication, between 01 Jan 2014 to 30 Apr 2022 (one month look forward required). Patients must have at least one eligible treatment episode (defined as aflibercept injection followed by 28-day exposed period after injection) to be included in the study.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of patients receiving aflibercept injections		End of Study, Approximately 8 Years
Frequency of aflibercept injections by ophthalmic delivery mechanism	Ophthalmic delivery mechanism defined as prefilled syringe (PFS) and vial	End of Study, Approximately 8 Years
Incidence of Intraocular inflammation (IOI)	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.	End of Study, Approximately 8 Years
Incidence of Intraocular inflammation (IOI) by ophthalmic delivery mechanism	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	End of Study, Approximately 8 Years
Incidence of suspected endophthalmitis	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.	End of Study, Approximately 8 Years
Incidence of suspected endophthalmitis by ophthalmic delivery mechanism	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	End of Study, Approximately 8 Years

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Collaborators: Bayer
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2022
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Vascular endothelial growth factor; Age-related macular degeneration; Diabetic macular edema; Diabetic retinopathy; Retinal vein occlusion; Endophthalmitis; Anti-vascular endothelial growth factor; Intraocular inflammation
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Eye Diseases; Uveal Diseases; Eye Infections; Inflammation; Uveitis; Endophthalmitis
• Other Study ID Numbers: VGFTe-OD-2222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No