NCT06769412Completed
A Real-World Evidence Study for the Incidence of Retinal Vasculitis (RV) Among Adult Patients Receiving Aflibercept 2 mg in the United States (US)
Incidence of Retinal Vasculitis Among Patients Receiving Aflibercept 2 mg: A US Real-World Evidence Study Using the IRIS Registry
Source: ClinicalTrials.gov · Last updated 29 Oct 2025
Brief summary (registry, in English)
This study will describe and estimate the incidence of RV events among patients and patient eyes receiving aflibercept intravitreal (IVT) (Eylea® 2mg) therapy in US clinical practice. This study will also use clinical record review to confirm cases of RV first identified using International Classification of Diseases, tenth revision, Clinical Modification (ICD-10-CM) codes and to identify RV with occlusion.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 550000 (actual)
- First submitted
- 24 Dec 2024
- Start date
- 1 Jul 2025
- Primary completion date
- 15 Aug 2025
- Lead sponsor
- Regeneron Pharmaceuticals
- Diseases
- Macular degeneration, Diabetic eye disease
- NCT number
- NCT06769412
What you commit to
- Study type: Observational
- Participants enrolled: 550000
- From 1 Jul 2025 to the primary completion date, 15 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with aflibercept 2 mg injection within 12 months (365 days) prior to the index date (not inclusive) will be excluded, as defined in the protocol
- 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
- Aflibercept treatment episodes (aflibercept injections) with unspecified laterality, ophthalmic procedures or surgeries within 60 days prior to the injection date
- NOTE: Other protocol defined inclusion/exclusion criteria may apply
Who the study is looking for
- Patient-eyes with at least one aflibercept 2 mg injection between January 1, 2017 and June 30, 2023
- Patient-eyes with at least one aflibercept 2 mg injection with a specified laterality. The earliest date of aflibercept injection will be the index date for each patient-eye
- Patient-eyes with diagnosis (documented through ICD-10-CM diagnosis code) of nAMD, DME, DR without DME, DR with ME status unknown, and/or ME following RVO in the same eye as the aflibercept injection within 14 days prior to the index date (inclusive)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Tarrytown | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.