Efficacy and Safety of the Biosimilar Ranibizumab FYB201 in Comparison to Lucentis in Patients With Neovascular Age-related Macular Degeneration

简要总结

主要结局

次要结局

• Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 24 Weeks(Baseline and Week 24)
• Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 48 Weeks(Baseline and Week 48)
• Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 12 Months(Baseline and 12 Months)
• Change in Foveal Centre Point (FCP) Retinal Thickness From Baseline to Week 24(Baseline and Week 24)
• Change in NEI VFQ-25 Composite Score From Baseline to Week 24(Baseline and Week 24)
• Fluid-free Macula at Each Visit(Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48)
• Anti-drug Antibodies Pre- and Post-first Dosing(Baseline and up to Week 48)
• Change in Foveal Centre Point (FCP) Retinal Thickness From Baseline to Week 48(Baseline and Week 48)
• Change in Foveal Central Subfield (FCS) Retinal Thickness From Baseline to Week 24(Baseline and Week 24)
• Change in Total Lesion Area From Baseline to Week 48(Baseline and Week 48)
• Change in NEI VFQ-25 Composite Score From Baseline to Week 48(Baseline and Week 48)
• Active CNV Leakage at Week 24(Baseline and Week 24)
• Active CNV Leakage at Week 48(Baseline and Week 48)
• Change in Foveal Central Subfield (FCS) Retinal Thickness From Baseline to Week 48(Baseline and Week 48)
• Change in Total Lesion Area From Baseline to Week 24(Baseline and Week 24)
• Anti-drug Antibodies by Scheduled eCRF Visit(Baseline and Weeks 1, 4, 12, 24, 48)