RECRUITING

Incidence of Retinal Vasculitis Among Patients Receiving Aflibercept: A US Real-World Evidence Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Incidence of Retinal Vasculitis Among Patients Receiving Aflibercept: A US Real-World Evidence Study

Quick Facts

Study Start:2025-07-15
Study Completion:2025-09-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07105228

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Aflibercept injections with unspecified laterality will be excluded
  2. 2. Aflibercept injections from individuals aged \<18 years or those with unknown age on the injection date will be excluded
  3. 3. 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
  4. 4. Patient-eyes that do not meet the continuous enrollment requirement will be excluded
  5. 5. Aflibercept injections will be excluded if there is ≥1 other anti-VEGF injection administered on the same date

Contacts and Locations

Study Contact

Clinical Trials Administrator
CONTACT
844-734-6643
clinicaltrials@regeneron.com

Principal Investigator

Clinical Trial Management
STUDY_DIRECTOR
Regeneron Pharmaceuticals

Study Locations (Sites)

Regeneron Research Site
Tarrytown, New York, 10591
United States

Collaborators and Investigators

Sponsor: Regeneron Pharmaceuticals

  • Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-15
Study Completion Date2025-09-15

Study Record Updates

Study Start Date2025-07-15
Study Completion Date2025-09-15

Terms related to this study

Keywords Provided by Researchers

  • Anti-Vascular Endothelial Growth Factor (VEGF)
  • Aflibercept
  • neovascular Age-related Macular Degeneration (nAMD)
  • Diabetic Macular Edema (DME)
  • Diabetic Retinopathy (DR)
  • Macular Edema Following Retinal Vein Occlusion (RVO)

Additional Relevant MeSH Terms

  • Retinal Vasculitis