NCT07520045

Biomarkers in Diabetic Retinopathy Treated With Faricimab vs Biosimilar Ranibizumab

A Comparative Analysis of OCT and OCT Angiography Biomarkers and Systemic Laboratory Parameters in Patients With Diabetic Retinopathy Undergoing Treatment With Faricimab or Biosimilar Ranibizumab Following Three Loading Doses

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Osijek University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to see if treatment with faricimab or biosimilar ranibizumab leads to different early imaging changes in adults with diabetic retinopathy requiring anti-VEGF treatment and to identify OCT and OCTA biomarkers predictive of differential early treatment response between the two therapies. The main questions it aims to answer are: Which OCT and OCT angiography biomarkers predict early treatment response? How do imaging biomarkers change after three loading doses of treatment? Are imaging biomarkers associated with systemic laboratory parameters? Researchers will compare faricimab to biosimilar ranibizumab to see if there are differences in imaging biomarkers and early treatment response. Participants will: * be randomized in a 1:1 ratio using a computer-generated randomization sequence * undergo comprehensive ophthalmic examinations, including visual acuity and intraocular pressure measurement * undergo OCT and OCT angiography imaging at each visit * receive three intravitreal injections during the loading phase * attend follow-up visits from baseline to 4-5 weeks after the third injection * provide blood samples for systemic laboratory analysis

Conditions

• Diabetic Retinopathy (DR)
• Diabetic Macular Edema (DME)

Interventions

Type	Name	Description
DRUG	Faricimab	Faricimab will be administered via intravitreal injection.
DRUG	Biosimilar ranibizumab	Biosimilar ranibizumab will be administered via intravitreal injection.

Timeline

• Start date: 2026-03-12
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2026-04-09
• Last updated: 2026-04-09

Locations

1 site across 1 country: Croatia