Early imaging changes with faricimab versus biosimilar ranibizumab for diabetic retinal disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with diabetic retinopathy, with or without central macular edema, are randomized 1:1 to receive intravitreal faricimab or a biosimilar ranibizumab and receive three loading doses. Participants undergo comprehensive eye exams with visual acuity, intraocular pressure checks, and OCT and OCT angiography imaging at each visit to track early anatomic changes. The study will analyze OCT/OCTA biomarkers to identify features that predict differential early response to the two drugs and will explore associations between imaging biomarkers and systemic laboratory parameters. Imaging changes after the loading phase will be compared between treatment arms to detect any early differences in response patterns.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospital Osijek
  Osijek, Croatia Recruiting

Study contacts

• Study coordinator: Ivanka Maduna, MD
• Email: ivankamadun@gmail.com
• Phone: +385981962588

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.