This study is designed for multi-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single and multiple intravitreal injection of IBI333 in subjects with neovascular age-related macular degeneration (nAMD).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Intravitreal injection of IBI333
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Safety and tolerance indicators
1. Incidence, relatedness and severity of all adverse events (AE), treatment emergent adverse events (TEAE) and serious adverse events (SAE); 2. Incidence of dose limiting toxicity;
Time frame: Through study completion, a maximum of 24 weeks
The area under the curve (AUC) of serum concentration of the drug after the administration.
Time frame: Through study completion, a maximum of 24 weeks
Maximum concentration (Cmax) of the drug after the administration.
Time frame: Through study completion, a maximum of 24 weeks
Time at which maximum concentration (Tmax) occurs for the drug after the administration.
Time frame: Through study completion, a maximum of 24 weeks
The half-life (t1/2) of drug after the administration .
Time frame: Through study completion, a maximum of 24 weeks
Number of participants with anti-drug antibodies or neutralizing antibodies .
Time frame: Through study completion, a maximum of 24 weeks
Changes of BCVA measured by ETDRS chart from baseline.
Time frame: Through study completion, a maximum of 24 weeks
Changes of CST measured by spectral domain optical coherence tomography (SD-OCT) from baseline.
Time frame: Through study completion, a maximum of 24 weeks
Proportion of subjects without intraretinal or subretinal fluid on SD-OCT.
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Time frame: Through study completion, a maximum of 24 weeks
Change of height of pigment epithelial detachment from baseline on SD-OCT.
Time frame: Through study completion, a maximum of 24 weeks