Biomarkers in Diabetic Retinopathy Treated With Faricimab vs Biosimilar Ranibizumab
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOsijek University Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Adults aged ≥18 years
Diabetic retinopathy with or without central macular edema
Indication for intravitreal anti-VEGF therapy according to current clinical guidelines
Ability to provide written informed consent
Disqualifiers
Intravitreal anti-VEGF or corticosteroid treatment in the study eye within 5 months prior to enrollment
Any intraocular surgery (including cataract surgery) 3 months prior intraocular surgery to enrollment
Retinal laser photocoagulation in the study eye within 3 months prior to enrollment
Presence of other ocular, retinal or macular diseases that may affect OCT/OCTA findings or visual acuity (e.g., age-related macular degeneration, retinal vascular occlusions)
Trial design
Design model
Parallel
Treatments tested in this trial
Faricimab
DrugFaricimab will be administered via intravitreal injection.
Biosimilar ranibizumab
DrugBiosimilar ranibizumab will be administered via intravitreal injection.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: FaricimabExperimental treatment 1 intervention
Group B: Biosimilar RanibizumabActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 injectionSecondary outcomes
1
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 injectionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Osijek University Hospital
Lead sponsor
Josip Juraj Strossmayer University of Osijek
Sponsor institution
Source ClinicalTrials.gov