A Study of the Incidence of Intraocular Inflammation and Suspected Endophthalmitis Among Patients Treated With Aflibercept, Vial and Pre-filled Syringe, 2014-2022
NCT ID: NCT05791695
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
155413 participants
OBSERVATIONAL
2022-09-16
2023-09-15
Brief Summary
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* 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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Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Study Patients
Patients ≥ 18 years who have received one or more injections of aflibercept during the study period
Non Applicable
No study-specific interventions for this observational study.
Interventions
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Non Applicable
No study-specific interventions for this observational study.
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Regeneron Research Site
Tarrytown, New York, United States
Countries
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Other Identifiers
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VGFTe-OD-2222
Identifier Type: -
Identifier Source: org_study_id