Biomarkers in Diabetic Retinopathy Treated With Faricimab vs Biosimilar Ranibizumab

Sponsor
Osijek University Hospital
Study ID
NCT07520045
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Faricimab — DRUG
    Faricimab will be administered via intravitreal injection.
  • Biosimilar ranibizumab — DRUG
    Biosimilar ranibizumab will be administered via intravitreal injection.

Study Details

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

Key Dates

First listed
Apr 9, 2026
Start date
Mar 12, 2026
Status verified
Apr 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Faricimab
    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.
  • Active Comparator: Biosimilar Ranibizumab
    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.

Primary Outcome Measure

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 ]

Central Contacts

Related Studies