An interventional study of Faricimab and Biosimilar ranibizumab in Diabetic Retinopathy (DR) and Diabetic Macular Edema (DME), sponsored by Osijek University Hospital. Recruiting at 1 site in Croatia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by Osijek University Hospital · Not applicable, Interventional, and Treatment
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:
773 studies on the registry are indexed under Diabetic Retinopathy; 139 are open to participants now.
This study's planned enrollment of 100 is above the median of 78 across 480 interventional studies indexed under Diabetic Retinopathy.
Browse Diabetic Retinopathy studies →Osijek University Hospital is the lead sponsor of 30 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive intravitreal faricimab 6 mg (0.05 mL per injection) administered as 3 loading doses at 4- to 5-week intervals, in accordance with standard clinical practice. Ophthalmic assessments, including visual acuity, OCT and OCT angiography, are performed at each visit, with the final assessment 4-5 weeks after the third injection.
Drug: Faricimab
Participants will receive intravitreal biosimilar ranibizumab 0.5 mg (0.05 mL per injection) administered as 3 loading doses at 4- to 5-week intervals, in accordance with standard clinical practice. Ophthalmic assessments, including visual acuity, OCT and OCT angiography, are performed at each visit, with the final assessment 4-5 weeks after the third injection.
Drug: Biosimilar ranibizumab
Faricimab will be administered via intravitreal injection.
Biosimilar ranibizumab will be administered via intravitreal injection.
Comparison of OCT and OCTA biomarkers associated with early anatomical treatment response to faricimab and biosimilar ranibizumab
Time frame: From enrollment to 4-5 weeks after the third intravitreal injection
Association between blood-derived laboratory parameters and imaging-based treatment response
Blood samples will be analyzed for complete blood count (CBC) with differential, C-reactive protein (CRP), lipid profile, urea, creatinine, glycated hemoglobin (HbA1c), and plasma glucose.
Time frame: From enrollment to 4-5 weeks after the third intravitreal injection
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Osijek University Hospital