Incidence of Retinal Vasculitis Among Patients Receiving Aflibercept: A US Real-World Evidence Study (NCT07105228) | Clinical Trial Compass
CompletedNot Applicable
Incidence of Retinal Vasculitis Among Patients Receiving Aflibercept: A US Real-World Evidence Study
United States290,000 participantsStarted 2025-07-15
Plain-language summary
This study will describe and estimate the incidence of Retinal Vasculitis (RV) events among patients and patient eyes receiving aflibercept intravitreal (IVT) (Eylea®, aflibercept 2mg) therapy in US clinical practice.
The main objective is to describe demographic and clinical characteristics of patients receiving aflibercept 2mg injections, to estimate the incidence of RV and RV plus Intraocular Inflammation (IOI) following aflibercept 2mg injections and to describe characteristics of RV cases.
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.
Exclusion criteria
. Aflibercept injections with unspecified laterality will be excluded
. Aflibercept injections from individuals aged \<18 years or those with unknown age on the injection date will be excluded
. Patient-eyes with a diagnosis of RV in the same eye as the aflibercept injection or with unspecified laterality within 12 months (365 days) prior to index date (inclusive), as defined in the protocol
. Patient-eyes that do not meet the continuous enrollment requirement will be excluded
. Aflibercept injections will be excluded if there is ≥1 other anti-VEGF injection administered on the same date
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
Incidence of RV events
Timeframe: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 7 years
2
Incidence of RV plus IOI events
Timeframe: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 7 years
3
Demographics characteristics
Timeframe: 12 months prior to the index date
4
Clinical characteristics: Number of participants with different retinal disease diagnosis categories
Timeframe: 12 months prior to the index date
5
Clinical characteristics: Mean Charlson Comorbidity Index (CCI) score
Timeframe: 12 months prior to the index date
6
Clinical characteristics: Summary of comorbidities reported as number of participants with different categories
Timeframe: 12 months prior to the index date
7
Clinical characteristics: Number of participants with prior anti-VEGF treatment