NCT07105228Completed
Incidence of Retinal Vasculitis Among Patients Receiving Aflibercept: A US Real-World Evidence Study
Source: ClinicalTrials.gov · Last updated 10 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 290000 (actual)
- First submitted
- 8 Jul 2025
- Start date
- 15 Jul 2025
- Primary completion date
- 30 Aug 2025
- Lead sponsor
- Regeneron Pharmaceuticals
- Diseases
- Macular degeneration, Diabetic eye disease
- NCT number
- NCT07105228
What you commit to
- Study type: Observational
- Participants enrolled: 290000
- From 15 Jul 2025 to the primary completion date, 30 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
- 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
Age
- Aflibercept injections from individuals aged \<18 years or those with unknown age on the injection date will be excluded
Other
- Aflibercept injections with unspecified laterality will be excluded
- 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
- NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply
Who the study is looking for
- 1\. All aflibercept injections identified by the Healthcare Common Procedure Coding System (HCPCS) or National Drug Code (NDC) from January 1, 2017, to February 29, 2024, as recorded in the Komodo close claims database.
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.