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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07520045
- Acronym / sponsor ID
- R1-2689/2026.
- Keywords
- Diabetic Retinopathy, ranibizumab, faricimab, biomarkers, OCT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Osijek University HospitalUniversity, hospital or other
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Faricimab | Experimental | Drug: FaricimabParticipants 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. |
| Biosimilar Ranibizumab | Active comparator | Drug: Biosimilar ranibizumabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FaricimabFaricimab will be administered via intravitreal injection. | Drug | Faricimab |
| Biosimilar ranibizumabBiosimilar ranibizumab will be administered via intravitreal injection. | Drug | Biosimilar Ranibizumab |
Primary outcome
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
1 secondary outcome
Association between blood-derived laboratory parameters and imaging-based treatment response
Time frame: From enrollment to 4-5 weeks after the third intravitreal injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivanka Maduna, MD (+385981962588, ivankamadun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.