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

Intraocular Inflammation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05791695
• Other study ID #: VGFTe-OD-2222
• Status: Completed
• Start date: September 16, 2022
• Est. completion date: September 15, 2023

Study information

• Verified date: October 2023
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155413
• Est. completion date: September 15, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Endophthalmitis
• Inflammation
• Intraocular Inflammation
• Uveitis

Intervention

Other:
• Non Applicable
No study-specific interventions for this observational study.

Locations

Country	Name	City	State
United States	Regeneron Research Site	Tarrytown	New York

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of patients receiving aflibercept injections		End of Study, Approximately 8 Years
Primary	Frequency of aflibercept injections by ophthalmic delivery mechanism	Ophthalmic delivery mechanism defined as prefilled syringe (PFS) and vial	End of Study, Approximately 8 Years
Primary	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
Primary	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
Primary	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
Primary	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