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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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Specific study objectives include:
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.
This study is entirely descriptive using secondary data from the Vestrum Health Retina Treatment and Outcomes database.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Patients | Patients ≥ 18 years who have received one or more injections of aflibercept during the study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non Applicable | Other | No study-specific interventions for this observational study. |
|
| 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 |
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Inclusion Criteria for a Treatment Episode:
Exclusion Criteria for a Treatment Episode:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regeneron Research Site | Tarrytown | New York | 10591 | United States |
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| End of Study, Approximately 8 Years |
| ID | Term |
|---|---|
| D014605 | Uveitis |
| D008268 | Macular Degeneration |
| D003930 | Diabetic Retinopathy |
| D009877 | Endophthalmitis |
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D015817 | Eye Infections |
| D007239 | Infections |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
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