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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05791695
Other study ID # VGFTe-OD-2222
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 16, 2022
Est. completion date September 15, 2023

Study information

Verified date October 2023
Source Regeneron Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 155413
Est. completion date September 15, 2023
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Intervention

Other:
Non Applicable
No study-specific interventions for this observational study.

Locations

Country Name City State
United States Regeneron Research Site Tarrytown New York

Sponsors (2)

Lead Sponsor Collaborator
Regeneron Pharmaceuticals Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of patients receiving aflibercept injections End of Study, Approximately 8 Years
Primary Frequency of aflibercept injections by ophthalmic delivery mechanism Ophthalmic delivery mechanism defined as prefilled syringe (PFS) and vial End of Study, Approximately 8 Years
Primary 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
Primary 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
Primary 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
Primary 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
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