This study is designed for single-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single intravitreal injection of IBI302 in patients with wet AMD.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Safety evaluation indicators
Decreasing of BCVA; b) Changes in intraocular pressure compared with baseline; c) Incidence, relatedness and severity of all adverse events, treatment emergent adverse events and serious adverse events;
Time frame: Baseline to Day43
Efficacy evaluation indicators
Changes in central subfield thickness by OCT compared with baseline; b) Changes in CNV area by FA compared with baseline; c) Changes in BCVA compared with baseline.
Time frame: Baseline to Day43
Immunogenicity evaluation indicators
Positive rate of anti-drug antibody and neutralizing antibody
Time frame: Baseline to Day43
The area under the drug-time curve from 0 to time t (AUC0-t)
Time frame: Baseline to Day43
The area under the curve at the time of 0-infinity (AUC0-∞)
Time frame: Baseline to Day43
The peak concentration (Cmax)
Time frame: Baseline to Day43
The peak time (Tmax)
Time frame: Baseline to Day43
Clearance rate (CL)
Time frame: Baseline to Day43
Half-life (t1/2)
Time frame: Baseline to Day43
Free and total VEGF concentration
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1mg/eye;Intraocular injection
2mg/eye;Intraocular injection
4mg/eye;Intraocular injection
Time frame: Baseline to Day43