Early imaging changes with faricimab versus biosimilar ranibizumab for diabetic retinal disease
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
This trial will see if faricimab or a biosimilar ranibizumab causes different early OCT and OCTA imaging changes in adults with diabetic retinopathy or diabetic macular edema who need anti-VEGF injections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Osijek University Hospital Academic / other |
| Drugs / interventions | faricimab, ranibizumab |
| Locations | 1 site (Osijek) |
| Trial ID | NCT07520045 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older with diabetic retinopathy (with or without central macular edema) who have an indication for intravitreal anti-VEGF treatment and can provide informed consent and reliable OCT/OCTA imaging are eligible.
Not a fit: Patients with recent intravitreal anti-VEGF or steroid treatment, recent intraocular surgery or laser, other retinal diseases, significant media opacities, or uncontrolled glaucoma that preclude reliable imaging are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the study could identify imaging signs that help doctors choose the anti-VEGF therapy most likely to work early for a given patient.
How similar studies have performed: Previous trials have shown faricimab is effective for diabetic retinal disease and several studies have linked OCT/OCTA features to treatment response, but using imaging biomarkers to predict differential early response between faricimab and ranibizumab remains an emerging area with limited definitive data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Osijek
- University Hospital Osijek — Osijek, Croatia (Recruiting)
Study contacts
- Study coordinator: Ivanka Maduna, MD
- Email: ivankamadun@gmail.com
- Phone: +385981962588
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.