Biomarkers in Diabetic Retinopathy Treated With Faricimab vs Biosimilar Ranibizumab

April 2, 2026 updated by: Ivanka Maduna, Osijek University Hospital

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.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Croatia
      • Osijek, Croatia, 31000
        • Recruiting
        • University Hospital Osijek
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Faricimab
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.
Drug: Faricimab
Faricimab will be administered via intravitreal injection.
Active Comparator: Biosimilar Ranibizumab
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.
Drug: Biosimilar ranibizumab
Biosimilar ranibizumab will be administered via intravitreal injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From enrollment to 4-5 weeks after the third intravitreal injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between blood-derived laboratory parameters and imaging-based treatment response
Time Frame: From enrollment to 4-5 weeks after the third intravitreal injection
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.
From enrollment to 4-5 weeks after the third intravitreal injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Osijek University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R1-2689/2026.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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