Actively Recruiting
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
Led by Osijek University Hospital · Updated on 2026-04-09
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adults with diabetic retinopathy, with or without central macular edema, who need anti-VEGF treatment. The trial compares two treatments, faricimab and biosimilar ranibizumab, to see how early imaging changes differ and to identify biomarkers from OCT and OCT angiography that may predict early response to these therapies. The study also looks at how these imaging markers relate to blood lab results. Participants are randomly assigned to receive either faricimab or biosimilar ranibizumab. Each treatment is given as three intravitreal injections, spaced 4 to 5 weeks apart, following standard medical practice. During the study, participants undergo eye exams including vision tests, intraocular pressure checks, and OCT/OCT angiography imaging at every visit. The final evaluation occurs 4 to 5 weeks after the third injection. Throughout the study, participants provide blood samples for laboratory analysis, and researchers closely monitor eye health and imaging changes. Follow-up visits occur from the start of the study to 4 to 5 weeks after the last injection. The main outcome is comparing imaging biomarkers linked to early treatment response between the two therapies. The study also assesses connections between blood laboratory measures and imaging findings to better understand treatment effects.
CONDITIONS
Brief Title
Biomarkers in Diabetic Retinopathy Treated With Faricimab vs Biosimilar Ranibizumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of diabetic retinopathy with or without central macular edema
- Need for intravitreal anti-VEGF therapy according to clinical guidelines
- Ability to provide written informed consent
You will not qualify if you...
- Anti-VEGF or corticosteroid treatment in the study eye within 5 months before enrollment
- Any intraocular surgery, including cataract surgery, within 3 months before enrollment
- Retinal laser photocoagulation in the study eye within 3 months before enrollment
- Other ocular, retinal, or macular diseases affecting imaging or vision (e.g., age-related macular degeneration, retinal vascular occlusions)
- Retinal detachment, preretinal fibrosis, or vitreomacular traction
- Significant media opacities preventing reliable imaging (e.g., dense cataract, vitreous hemorrhage)
- Uncontrolled glaucoma with intraocular pressure over 30 mmHg in study eye
- Active ocular inflammation or suspected ocular infection
- Febrile illness within 1 week before first injection
- Clinically significant diseases or conditions that may interfere with treatment or study results
- Women who are pregnant, breastfeeding, or planning pregnancy within the next 100 weeks
- Known allergy to faricimab, biosimilar ranibizumab, or their ingredients
- Participation in another clinical trial that may affect study outcomes
- Inability to comply with study procedures or follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 to 15 weeks
Participants receive three loading doses of either intravitreal faricimab or biosimilar ranibizumab administered at 4- to 5-week intervals. Ophthalmic assessments, including visual acuity, OCT, and OCT angiography, are performed at each injection visit.
3 injection visits and associated ophthalmic assessment visits
Duration - 4 to 5 weeks
Participants undergo a final ophthalmic assessment 4 to 5 weeks after the third injection to evaluate treatment response.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
University Hospital Osijek
Osijek, Croatia, 31000
Actively Recruiting
Research Team
I
Ivanka Maduna, MD
A
Andrijana Kopić, MD, PhD
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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