CompletedNot Applicable

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

United States155,413 participantsStarted 2022-09-16

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

✕. 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).

What they're measuring

Frequency of patients receiving aflibercept injections

Timeframe: End of Study, Approximately 8 Years

Frequency of aflibercept injections by ophthalmic delivery mechanism

Timeframe: End of Study, Approximately 8 Years

Incidence of Intraocular inflammation (IOI)

Timeframe: End of Study, Approximately 8 Years

Incidence of Intraocular inflammation (IOI) by ophthalmic delivery mechanism

Timeframe: End of Study, Approximately 8 Years

Incidence of suspected endophthalmitis

Timeframe: End of Study, Approximately 8 Years

Incidence of suspected endophthalmitis by ophthalmic delivery mechanism

Timeframe: End of Study, Approximately 8 Years

Trial details

NCT IDNCT05791695

SponsorRegeneron Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-12-30

View on ClinicalTrials.gov More Intraocular Inflammation trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

✕. 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).

What they're measuring

Frequency of patients receiving aflibercept injections

Timeframe: End of Study, Approximately 8 Years

Frequency of aflibercept injections by ophthalmic delivery mechanism

Timeframe: End of Study, Approximately 8 Years

Incidence of Intraocular inflammation (IOI)

Timeframe: End of Study, Approximately 8 Years

Incidence of Intraocular inflammation (IOI) by ophthalmic delivery mechanism

Timeframe: End of Study, Approximately 8 Years

Incidence of suspected endophthalmitis

Timeframe: End of Study, Approximately 8 Years

Incidence of suspected endophthalmitis by ophthalmic delivery mechanism

Timeframe: End of Study, Approximately 8 Years