Clinical trial NCT05791695: A Study of the Incidence of Intraocular Inflammation and Suspected Endophthalmitis Among Patients Treated With Aflibercept, Vial and Pre-filled Syringe, 2014-2022
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2023-03-30
Enrollment: 155413
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Frequency of patients receiving aflibercept injections
timeFrame: End of Study, Approximately 8 Years
measure: Frequency of aflibercept injections by ophthalmic delivery mechanism
timeFrame: End of Study, Approximately 8 Years
measure: Incidence of Intraocular inflammation (IOI)
timeFrame: End of Study, Approximately 8 Years
measure: Incidence of Intraocular inflammation (IOI) by ophthalmic delivery mechanism
timeFrame: End of Study, Approximately 8 Years
measure: Incidence of suspected endophthalmitis
timeFrame: End of Study, Approximately 8 Years
measure: Incidence of suspected endophthalmitis by ophthalmic delivery mechanism
timeFrame: End of Study, Approximately 8 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Tarrytown
country: United States
facility: Regeneron Research Site
state: New York
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: