This study is designed for Open-label, multi-center, single-arm Phase II trail to evaluate the efficacy and safety of intravitreal injection of IBI302 in nAMD patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
800
8 mg IBI302 will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks.
Shanghai general hospital
Shanghai, Shanghai Municipality, China
RECRUITINGProportion of participants whose best corrected visual acuity (BCVA) of the study eye decreased by less than 15 letters from baseline as measured by the visual acuity chart in the early treatment diabetic retinopathy study (ETDRS) at week 52
Time frame: Week52
The changes in BCVA from baseline at each visit
Time frame: Baseline,Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and 52
Proportion of patients with BCVA improvement of ≥0, ≥5, ≥10, and ≥15 ETDRS letters from baseline at week 52
Time frame: Week52
Proportion of participants with a decrease in BCVA of >0, ≥5, ≥10, and ≥15 ETDRS letters from baseline at week 52
Time frame: Week52
The change in central subfield thickness of the macula measured by OCT from the baseline at week 52
Time frame: Week52
Proportion of participants with IRF/SRF/Pigment epithelial detachment (PED) on OCT at Week 52
Time frame: Week52
Change in choroidal neovascularization (CNV) area on fundus fluorescein angiography (FFA) at week 52 compared to baseline
Time frame: Week52
Change in CNV leakage area on FFA at week 52 compared to baseline
Time frame: Week52
Proportion of participants with new-onset MA on OCT at Week 52
Time frame: Week52
Proportion of new-onset fibrosis on color fundus photography (CFP) at Week 52
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Time frame: Week52
Change in MA area on OCT from baseline at Week 52
Time frame: Week52
Change in fibrosis area and maximum lesion diameter on CFP from baseline at Week 52
Time frame: Week52
The incidence rate, correlation with the studied drugs, and severity of ocular and systemic adverse events (AE), treatment emergent adverse events (TEAE), and serious adverse events (SAE)
Time frame: From baseline through Week 52
The production of anti-drug antibodies in the serum
Time frame: Day0、Week4、Week16、Week32、Week48、Week52