The study is designed for multi-center,randomized,double-masked,active-contralled study to evaluate effective and security of intravitreal injection of IBI302 in subjects with neovascular age-related macular degeneration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
600
2mg Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive monthes, folloesd by once every 8 weeks(Q8W).
8 mg IBI302 will be administered by intraitreal injection into the study eye at intervals as specified in the study protocol.
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Mean change from baseline in Best corrected visual acuity ( BCVA ) in the study eye.
Change from Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score at week 44, 48, 52.
Time frame: At week 44, 48, 52
The proportion of participants with absence intraretinal fluid (IRF) and absence subretinal fluid (SRF) in the fovea at Week 16
The intraretinal fluid and subretinal fluid is measured by optical coherence tomography (OCT) in the central subfield(center 1 millimeter)
Time frame: At week 16
Change from baseline in BCVA at Week 52 and 100
Best corrected visual acuity (BCVA) was measured on early treatment diabetic retinopathy study(ETDRS) chart at a starting distance of 4 meters. The BCVAletter score ranges from 0 to 100(best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
Time frame: Upto Week 100
Change from baseline in central subfield thickness (CST) measured by optical coherence tomography (OCT) at Week 52 and 100
Central subfield thickness was defined as the distance between the internal limiting member and the Bruch's member using OCT, as assessed by the central reading center.
Time frame: Upto Week 100
Change from baseline in area of CNV on fundus fluorescence angiography (FFA) at Week 52 and 100
the area of the choroidal neovascularization lesion in the study eye was measured by a central reading center using FFA
Time frame: Upto Week 100
Proportion of participants on a q8W, q12W, and q16W treatment intervals at Week 52 and 100
Percentages are based on number of participants randomized to the IBI302 group who have not discontinued the study at week 52 and 100. the treatment interval at a givven visit is defined as the treatment interval decision followed at that visit.
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Time frame: Upto Week 100
Incidence, relatedness to the study drug and severity of ocular and Non-ocular adverse events (AE), treatment emergent adverse events (TEAE) and serious adverse events (SAE).
All AEs were recorded and the investigator made an assessment of seriousness,severity, and causality of each AE.
Time frame: Upto Week 100