Actively Recruiting
Biomarkers in Diabetic Retinopathy Treated With Faricimab vs Biosimilar Ranibizumab
Led by Osijek University Hospital · Updated on 2026-04-09
100
Participants Needed
1
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Biomarkers in Diabetic Retinopathy Treated With Faricimab vs Biosimilar Ranibizumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 63;18 years
- Diagnosis of diabetic retinopathy with or without central macular edema
- Indication for intravitreal anti-VEGF therapy based on current clinical guidelines
- Ability to provide written informed consent
You will not qualify if you...
- Received intravitreal anti-VEGF or corticosteroid treatment in the study eye within 5 months before enrollment
- Underwent any intraocular surgery, including cataract surgery, within 3 months before enrollment
- Retinal laser photocoagulation in the study eye within 3 months prior to enrollment
- Presence of other eye diseases affecting OCT/OCTA or vision, such as age-related macular degeneration or retinal vascular occlusions
- Retinal detachment, preretinal fibrosis, or vitreomacular traction
- Significant media opacities preventing reliable imaging, like dense cataract or vitreous hemorrhage
- Uncontrolled glaucoma with intraocular pressure above 30 mmHg in the study eye
- Active inflammation or suspected infection in either eye
- Any feverish illness within 1 week before the first injection
- Any significant medical condition or abnormal exam that may increase risk or affect study results as judged by the investigator
- Women who are pregnant, breastfeeding, or planning pregnancy within 100 weeks
- Known allergy to faricimab, biosimilar ranibizumab, or their components
- Participation in another clinical trial that might affect this study
- Inability to follow study procedures or attend follow-up visits
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Osijek
Osijek, Croatia, 31000
Actively Recruiting
Research Team
I
Ivanka Maduna, MD
CONTACT
A
Andrijana Kopić, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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