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NCT Number: NCT07520045

Biomarkers in Diabetic Retinopathy Treated With Faricimab vs Biosimilar Ranibizumab

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

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Key information

Conditions

Diabetic Retinopathy (DR) Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Macular Edema (DME) Diabetic Retinopathy Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Osijek

Osijek, 31000, Croatia

Location status: Recruiting

Location contact

Ivanka Maduna

CONTACT

[email protected]

0981962588

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Faricimab

Drug

Faricimab will be administered via intravitreal injection.

Biosimilar ranibizumab

Drug

Biosimilar ranibizumab will be administered via intravitreal injection.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrijana Kopić, MD, PhD

CONTACT

[email protected]

+385981776750

Ivanka Maduna, MD

CONTACT

[email protected]

+385981962588

Sponsors and collaborators

Lead sponsor

Osijek University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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