Diabetic Retinopathy (DR)NCT07520045
Biomarkers in Diabetic Retinopathy Treated With Faricimab vs Biosimilar Ranibizumab
A study testing Faricimab and Biosimilar ranibizumab in people with Diabetic Retinopathy (DR) and Diabetic Macular Edema (DME), run by Osijek University Hospital at 1 site in Croatia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy (DR), Diabetic Macular Edema (DME)
- What is being tested?
- Faricimab and Biosimilar ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCroatia
- Study dates
- 12 Mar 2026to 1 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
- Retinal detachment, preretinal fibrosis, vitreomacular traction
- Significant media opacities (e.g., dense cataract, vitreous hemorrhage) precluding reliable OCT/OCTA imaging
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- Uncontrolled glaucoma (intraocular pressure > 30 mmHg in study eye)
- Active ocular inflammation
- Suspected active ocular infection in either eye
- Any febrile illness within 1 week prior to first injection
- History or presence of any clinically significant disease, non-diabetic metabolic disorder, abnormal physical examination finding, or laboratory abnormality that, in the opinion of the investigator, may contraindicate treatment with faricimab or biosimilar ranibizumab, interfere with the interpretation of study results, or place the participant at increased risk of treatment-related complications.
- Women who are pregnant, breastfeeding, or planning pregnancy within the next 100 weeks
- Known hypersensitivity to faricimab or biosimilar ranibizumab or any of its excipients
- Participation in another clinical trial that may affect study outcomes
- Inability to comply with study procedures or follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site, 1 recruiting
- Recruiting
University Hospital Osijek
Osijek, 31000
Ivanka Maduna, 0981962588, ivankamadun@gmail.com
About this study
Official title: 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
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.
Read more
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
- Being tested
- Faricimab, Biosimilar ranibizumab
- Keywords
- Diabetic Retinopathy, ranibizumab, faricimab, biomarkers, OCT
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FaricimabDrug
Faricimab will be administered via intravitreal injection.
Biosimilar ranibizumabDrug
Biosimilar ranibizumab will be administered via intravitreal injection.
| Study group | Role | What they receive |
|---|---|---|
| Faricimab | Experimental | 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. Receives: Drug: Faricimab |
| Biosimilar Ranibizumab | Active comparator | 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. Receives: Drug: Biosimilar ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of OCT and OCTA biomarkers associated with early anatomical treatment response to faricimab and biosimilar ranibizumab
Measured: From enrollment to 4-5 weeks after the third intravitreal injection
Secondary 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.
Measured: From enrollment to 4-5 weeks after the third intravitreal injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start12 Mar 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Retinopathy (DR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osijek University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivanka Maduna, Josip Juraj Strossmayer University of Osijek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520045
- Sponsor's protocol ID
- R1-2689/2026.
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No