This study is a randomized, multi-center, double blind, Lucentis controlled non-inferiority study in neovascular age-related macular degeneration patients. The objective of this study is to compare the efficacy and safety of TAB014 and ranibizumab (Lucentis).
Primary Objectives: To evaluate the efficacy of TAB014 compared to Lucentis in neovascular age-related macular degeneration patients Secondary Objectives: 1. To evaluate the safety of TAB014 compared to Lucentis in neovascular age-related macular degeneration patients. 2. To evaluate the immunogenicity of TAB014 in neovascular age-related macular degeneration patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
488
intravitreal injection at 1.25mg once every 4 weeks
intravitreal injection at 0.5mg once every 4 weeks
Evaluate the change in BCVA of the study eye from TAB014 and ranibizumab treatment groups.
Best-corrected visual acuity (BCVA) letter score as measured by the ETDRS chart
Time frame: At week 52
Evaluate the change in BCVA of the study eye
Best-corrected visual acuity (BCVA) letter score as measured by the ETDRS chart
Time frame: At week 12, 24 and 36
Evaluate the proportion of subjects with an increase in BCVA of >5, >10, and >15 in the study eye
Best-corrected visual acuity (BCVA) letter score as measured by the ETDRS chart
Time frame: At week 12, 24 and 52
Evaluate the proportion of subjects with a BCVA loss of <5, <10, < 15 letters in the study eye
Best-corrected visual acuity (BCVA) letter score as measured by the ETDRS chart
Time frame: At week 12, 24 and 52
Change in central subfield thickness(CST) in the study eye
CST measured by SD-OCT as assessed by independent central reading center
Time frame: At week 12, 24, 36 and 52
Change in Choroidal Neovascularization (CNV) area of study eye
CNV as assessed by independent central reading center
Time frame: At week 12, 24 and 52
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The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Aier Intech Eye Hospital
Beijing, Beijing Municipality, China
Peking University People'S Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital, Cmu
Beijing, Beijing Municipality, China
The First Hospital of Jilin University
Jilin City, Changchun, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
...and 46 more locations