Skip to main content
OpenTrials
Completed

NCT Number: NCT05791695

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intraocular Inflammation Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Embolism and Thrombosis Endocrine System Diseases Endophthalmitis Eye Diseases Eye Infections Infections Macular Degeneration Retinal Degeneration Retinal Diseases Retinal Vein Occlusion Suspected Endophthalmitis Thrombosis Uveal Diseases Uveitis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Regeneron Research Site

Tarrytown, New York, 10591, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Non applicable

Other

No study-specific interventions for this observational study.

Primary outcomes

  1. Frequency of patients receiving aflibercept injections

    Time frame: End of Study, Approximately 8 Years

  2. Frequency of aflibercept injections by ophthalmic delivery mechanism

    Time frame: End of Study, Approximately 8 Years

    Ophthalmic delivery mechanism defined as prefilled syringe (PFS) and vial

  3. Incidence of Intraocular inflammation (IOI)

    Time frame: 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.

  4. Incidence of Intraocular inflammation (IOI) by ophthalmic delivery mechanism

    Time frame: 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

  5. Incidence of suspected endophthalmitis

    Time frame: 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.

  6. Incidence of suspected endophthalmitis by ophthalmic delivery mechanism

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Bayer

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Mar 30, 2023
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.