This study is designed to compare the efficacy, safety and immunogenicity of LUBT010 with Lucentis® given as once monthly intravitreal injection in patients with neovascular age-related macular degeneration (AMD).
This is a global, phase III, double blind, randomized controlled study to compare the efficacy, safety \& immunogenicity of LUBT010 with Lucentis® in patients with neovascular age-related macular degeneration. Eligible patients will be randomly assigned in 1:1 ratio to receive once monthly intravitreal injection of LUBT010 or Lucentis® for 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
600
LUBT010 (proposed ranibizumab biosimilar) 0.5 mg via intravitreal injection once monthly
Lucentis® 0.5 mg via intravitreal injection once monthly
Mean Change in BCVA From Baseline in the Study Eye at the End of 12 Months
Early treatment diabetic retinopathy study (ETDRS) charts were used for visual acuity measurement
Time frame: Baseline and 12 Months
Mean Change in BCVA From Baseline in the Study Eye at the End of 3 Months
ETDRS charts were used for visual acuity measurement summarized descriptively by treatment arm and time point
Time frame: Baseline and 3 Months
Mean Change in BCVA From Baseline in the Study Eye at the End of 6 Months
ETDRS charts were used for visual acuity measurement summarized descriptively by treatment arm and time point
Time frame: Baseline and 6 Months
Mean Change in BCVA From Baseline in the Study Eye at the End of 9 Months
ETDRS charts were used for visual acuity measurement summarized descriptively by treatment arm and time point
Time frame: Baseline and 9 Months
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