RecruitingNot ApplicableNCT07520045

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


Sponsor

Osijek University Hospital

Enrollment

100 participants

Start Date

Mar 12, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Biosimilar ranibizumab and a drug called Faricimab for people with diabetic macular edema (dme) and diabetic retinopathy (dr). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFaricimab

Faricimab will be administered via intravitreal injection.

DRUGBiosimilar ranibizumab

Biosimilar ranibizumab will be administered via intravitreal injection.


Locations(1)

University Hospital Osijek

Osijek, Croatia

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NCT07520045


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