This study is designed for multi-center, open-label, randomized, dose escalation phase I trial to evaluate the safety and tolerability of a multiple dose intravitreal injection of IBI302 in neovascular AMD patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
q4week (3 injections) followed by PRN dosing
q4week (3 injections) followed by PRN dosing
2mg, q4week (3 injections) followed by q8week
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Ocular safety, assessed by BCVA, slitlamp examination, ophthalmoscopy, IOP, fundus photography
Time frame: Baseline to Day140
Incidence of adverse events
Time frame: Baseline to Day140
Changes in central subfield thickness by OCT compared with baseline
Time frame: Baseline to Day140
Changes in CNV characteristics and CNV area by FA compared with baseline
Time frame: Baseline to Day140
Changes in BCVA compared with baseline
Time frame: Baseline to Day140
Positive rate of anti-drug antibody and neutralizing antibody of IBI302
Time frame: Baseline to Day140
the area under the drug-time curve from 0 to time t of IBI302
Time frame: Baseline to Day140
the area under the curve at the time of 0-infinity of IBI302
Time frame: Baseline to Day140
The peak concentration of IBI302
Time frame: Baseline to Day140
The peak time of IBI302
Time frame: Baseline to Day140
Clearance rate of IBI302
Time frame: Baseline to Day140
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Half-life of IBI302
Time frame: Baseline to Day140
VEGF concentration
Time frame: Baseline to Day140
Concentration of complement fragments
Time frame: Baseline to Day140