Biomarkers in Diabetic Retinopathy Treated With Faricimab vs Biosimilar Ranibizumab

NCT07520045 | Recruiting

• 1 other identifier: R1-2689/2026.
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Diabetic Retinopathy (DR); Diabetic Macular Edema (DME)

Keywords

Diabetic Retinopathy; ranibizumab; faricimab; biomarkers; OCT

Outcome Measures

Primary Outcomes (1)

• Comparison of OCT and OCTA biomarkers associated with early anatomical treatment response to faricimab and biosimilar ranibizumab

  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

  From enrollment to 4-5 weeks after the third intravitreal injection

Study Arms (2)

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.

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.

Drug: Biosimilar ranibizumab

Interventions

Faricimab DRUG

Faricimab will be administered via intravitreal injection.

Faricimab

Biosimilar ranibizumab DRUG

Biosimilar ranibizumab will be administered via intravitreal injection.

Biosimilar Ranibizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Osijek University Hospital: lead

Study Sites (1)

University Hospital Osijek

Osijek, 31000, Croatia

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

faricimab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

Ivanka Maduna, MD

CONTACT

+385981962588; ivankamadun@gmail.com

Andrijana Kopić, MD, PhD

CONTACT

+385981776750; andrijanakopic@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD Candidate

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 9, 2026
• Study Start: March 12, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

CR (1)