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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Faricimab | Experimental | 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. |
|
| Biosimilar Ranibizumab | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faricimab | Drug | Faricimab will be administered via intravitreal injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of OCT and OCTA biomarkers associated with early anatomical treatment response to faricimab and biosimilar ranibizumab | From enrollment to 4-5 weeks after the third intravitreal injection |
| Measure | Description | Time Frame |
|---|---|---|
| Association between blood-derived laboratory parameters and imaging-based treatment response | 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. | From enrollment to 4-5 weeks after the third intravitreal injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ivanka Maduna, MD | Contact | +385981962588 | ivankamadun@gmail.com | |
| Andrijana Kopić, MD, PhD | Contact | +385981776750 | andrijanakopic@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Osijek | Recruiting | Osijek | 31000 | Croatia |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C000723200 | faricimab |
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| Biosimilar ranibizumab |
| Drug |
Biosimilar ranibizumab will be administered via intravitreal injection. |
|
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |