This is a multi-center, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of IBI302 in subjects with neovascular age-related macular degeneration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
231
Low dose IBI302 intravitreal injection given as every other month after three loading monthly injection
High dose IBI302 intravitreal injection given as every other month after three loading monthly injection
Intraocular injection
Innovent Biologics (Suzhou) Co,Ltd.
Suzhou, Jiangsu, China
The visual efficacy of IBI302
Time frame: Baseline to week 36
other visual effects of IBI302
the proportion if BCVA improvement ≥0,5,10 or 15 letters at week 12, 28, 36 and 52.
Time frame: Baseline to week 52
the anatomical effects of IBI302 on OCT
the mean change of central subfield thickness from BL to week 52 at week 12, 28, 36 and 52
Time frame: Baseline to week 52
the anatomical effects of IBI302 on FFA
the change of CNV area, CNV leakage area, total lesion area from BL to week 36 or 52
Time frame: Baseline to week 52
the safety of IBI302
the incidence of ocular AE or any systemic AE, TEAE, SAE
Time frame: Baseline to week 52
Immunogenicity of IBI302
the positive rate of anti-drug antibody and neutralizing antibody
Time frame: Baseline to week 52
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