Corporate sponsorship
Conditions
Interventions
Experimental group:Treatment Period: 0-52 weeks
Loading Phase: Week 0 to week 12
Injection schedule: One injection of faricimab at week 0, week 4, week 8, and week 12 for a total of four doses.
Maint
Sponsors
Inner Mongolia Chaoyu Eye Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age requirement Age >= 18 years. 2. Diabetes diagnosis Meet the diagnostic criteria for diabetes (type 1 or type 2). 3. DME diagnosis Confirmed by optical coherence tomography (OCT) that there is fluid leakage or thickening in the macular central area, and the central retinal thickness (CRT) is higher than the normal reference value. 4. Vision requirement The best corrected visual acuity (BCVA) of the study eye is in the range of 20/32 to 20/320 (corresponding to approximately 78 to 24 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart) in the early treatment of diabetic retinopathy studies. 5. Treatment requirement Patients with DME who need to receive anti-vascular endothelial growth factor (VEGF) or other new therapies. 6. Single eye study Only one eye is selected as the study eye to participate in the trial (if both eyes meet the inclusion criteria, the investigator needs to choose the more suitable eye to participate in the study). 7. Stable condition No obvious vitreous hemorrhage, tractional retinal detachment or other serious complications that affect the assessment of the retina. 8. General health condition Good blood sugar control, with glycated hemoglobin (HbA1c) = 10%. Normal liver and kidney function, blood pressure and coagulation function. 9. Previous treatment Can include patients who have received anti-VEGF treatment in the past, but need to discontinue the treatment for at least 3 months before enrollment, or patients who have not received anti-VEGF treatment. 10. Compliance The patient and their legal representative can understand and sign the informed consent form, and are willing to comply with the follow-up and treatment plan stipulated in the research protocol.
Exclusion criteria
Exclusion criteria: 1. Any other ocular diseases or systemic diseases may affect the assessment of vision. 2. Patients who have received any anti-VEGF drugs or laser treatment within the past 3 months. 3. Patients who are allergic to fraxinib or any of its components. 4. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The average value of the best corrected visual acuity (BCVA) change (compared with the baseline);The change in central retinal thickness (CRT); | — |
Secondary
| Measure | Time frame |
|---|---|
| The average value of the change in the best corrected visual acuity (BCVA) of the affected eye (compared with the baseline);The proportion of patients whose visual acuity improved by >=15 letters;Adverse events and serious adverse events that occurred during the treatment period;The change in central retinal thickness (CRT); | — |
Countries
China
Contacts
Public ContactGuisen Zhang
Inner Mongolia Chaoyu Eye Hospital
Outcome results
None listed