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

NCT05791695 | Completed

• 1 other identifier: VGFTe-OD-2222
• Study Type: observational
• Target: 155,413
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraocular Inflammation; Suspected Endophthalmitis

Keywords

Age-related macular degeneration; Anti-vascular endothelial growth factor; Diabetic macular edema; Diabetic retinopathy; Endophthalmitis; Intraocular inflammation; Retinal vein occlusion; Vascular endothelial growth factor

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Study Patients

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

Other: Non Applicable

Interventions

Non Applicable OTHER

No study-specific interventions for this observational study.

Study Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Bayer: collaborator

Study Sites (1)

Regeneron Research Site

Tarrytown, New York, 10591, United States

Location

MeSH Terms

Conditions

Uveitis; Macular Degeneration; Diabetic Retinopathy; Endophthalmitis; Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases; Retinal Degeneration; Retinal Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Eye Infections; Infections; Venous Thrombosis; Thrombosis; Embolism and Thrombosis

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 30, 2023
• Study Start: September 16, 2022
• Primary Completion: December 30, 2022
• Study Completion: September 15, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)