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

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

Official Title
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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

Conditions
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Intraocular Inflammation, Suspected Endophthalmitis

Intervention / Treatment
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* Other: Non Applicable


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Age-related macular degeneration, Anti-vascular endothelial growth factor, Diabetic macular edema, Diabetic retinopathy, Endophthalmitis, Intraocular inflammation, Retinal vein occlusion, Vascular endothelial growth factor