Not a traditional drug phase: testing Faricimab for Diabetic Retinopathy (DR)
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?
Official registry: https://clinicaltrials.gov/study/NCT07520045 · Osijek University Hospital · enrollment listed as 100
What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Faricimab, or Biosimilar ranibizumab. The registry lists allocation as randomized. 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.
They plan to enroll about 100 people at Osijek. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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
Interventions: Faricimab, Biosimilar ranibizumab
Primary outcome (registry wording): Comparison of OCT and OCTA biomarkers associated with early anatomical treatment response to faricimab and biosimilar ranibizumab
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Adults aged ≥18 years
- Diabetic retinopathy with or without central macular edema
- Indication for intravitreal anti-VEGF therapy according to current clinical guidelines
Who the registry excludes
- 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)
Public study contact (from the registry)
Ivanka Maduna, MD
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- University Hospital Osijek — Osijek, Croatia (recruiting)
FAQ about this NCT record
Is NCT07520045 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07520045?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07520045?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary