A Study of the Incidence of Intraocular Inflammation and Suspected Endophthalmitis Among Patients… (NCT05791695) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of patients receiving aflibercept injections
Timeframe: End of Study, Approximately 8 Years
2
Frequency of aflibercept injections by ophthalmic delivery mechanism
Timeframe: End of Study, Approximately 8 Years
3
Incidence of Intraocular inflammation (IOI)
Timeframe: End of Study, Approximately 8 Years
4
Incidence of Intraocular inflammation (IOI) by ophthalmic delivery mechanism
Timeframe: End of Study, Approximately 8 Years
5
Incidence of suspected endophthalmitis
Timeframe: End of Study, Approximately 8 Years
6
Incidence of suspected endophthalmitis by ophthalmic delivery mechanism