Intraocular Inflammation, Suspected Endophthalmitis
Conditions
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
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.
Interventions
OTHERNon Applicable
No study-specific interventions for this observational study.
Sponsors
Bayer
Regeneron Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of patients receiving aflibercept injections | End of Study, Approximately 8 Years | — |
| Frequency of aflibercept injections by ophthalmic delivery mechanism | End of Study, Approximately 8 Years | Ophthalmic delivery mechanism defined as prefilled syringe (PFS) and vial |
| Incidence of Intraocular inflammation (IOI) | End of Study, Approximately 8 Years | 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. |
| Incidence of Intraocular inflammation (IOI) by ophthalmic delivery mechanism | End of Study, Approximately 8 Years | 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 |
| Incidence of suspected endophthalmitis | End of Study, Approximately 8 Years | 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. |
| Incidence of suspected endophthalmitis by ophthalmic delivery mechanism | End of Study, Approximately 8 Years | 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 |
Countries
United States
Outcome results
None listed