This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy and safety of QL1207 compared to Eylea® in subjects with wet AMD.
Subjects will be randomised in a 1:1 ratio to receive either QL1207 or Eylea® (administered via intravitreal \[IVT\] injection 2 mg \[0.05 mL\] every 4 weeks for the first 3 months (i.e., at Weeks 0, 4, and 8), followed by 2 mg \[0.05 mL\] once every 8 weeks ) . Subjects will be administered the study drug up to week 48, and the last assessment will be done at Week 52.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
366
Intravitreal (IVT) injection
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12
Time frame: Baseline (Day 0), Week 12
Proportion of subjects who gained at least 5,10 and 15 lettersbaseline to week 12,week 24 and week 52
Time frame: Baseline (Day 0), Week 12, Week 24, Week 52
Change From Baseline in CRT(central retina thickness) by visit
Time frame: Baseline (Day 0), week 4, week 8, Week 12, Week 24, Week 52
BCVA Change From Baseline by visit
Time frame: Baseline (Day 0), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52
Change from baseline in CNV area from baseline to week 12, week 24 and week 52
Time frame: Baseline (Day 0), Week 12, Week 24, Week 52
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