Study Comparing Faricimab and Biosimilar Ranibizumab Treatments in Adults With Diabetic Retinopathy Using Eye Imaging and Blood Tests

What this Trial Is About

Researchers are studying adults with diabetic retinopathy, with or without central macular edema, who need anti-VEGF treatment. The trial compares two treatments, faricimab and biosimilar ranibizumab, to see how early imaging changes differ and to identify biomarkers from OCT and OCT angiography that may predict early response to these therapies. The study also looks at how these imaging markers relate to blood lab results. Participants are randomly assigned to receive either faricimab or biosimilar ranibizumab. Each treatment is given as three intravitreal injections, spaced 4 to 5 weeks apart, following standard medical practice. During the study, participants undergo eye exams including vision tests, intraocular pressure checks, and OCTOCT angiography imaging at every visit. The final evaluation occurs 4 to 5 weeks after the third injection. Throughout the study, participants provide blood samples for laboratory analysis, and researchers closely monitor eye health and imaging changes. Follow-up visits occur from the start of the study to 4 to 5 weeks after the last injection. The main outcome is comparing imaging biomarkers linked to early treatment response between the two therapies. The study also assesses connections between blood laboratory measures and imaging findings to better understand treatment effects.

Biomarkers in Diabetic Retinopathy Treated With Faricimab vs Biosimilar Ranibizumab