Multicenter, open-label, multi-dose study to evaluate the safety and tolerability in patients with nAMD treated with SCT520FF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
82
Tianjin Medical University Eye Hospital
Tianjing, China
RECRUITINGTreatment emergent adverse events(TEAE)
Incidence of treatment emergent adverse events
Time frame: From Day 0 up to 196days
Treatment-related treatment emergent adverse events(TRAE)
Incidence of treatment-related treatment emergent adverse events
Time frame: From Day 0 up to 196days
Serious adverse event(SAE)
Incidence of serious adverse event
Time frame: From Day 0 up to 196days
Adverse event of special interest(AESI)
Incidence of adverse event of special interest
Time frame: From Day 0 up to 196days
Dose limited toxicity(DLT)
Incidence of dose-limiting toxicities
Time frame: From Day 0 up to 196days
Best corrected visual acuity(BCVA)
Mean change from baseline in BCVA
Time frame: Day 0 up to 196 days
central retina thickness(CRT)
Mean change from baseline in CRT
Time frame: Day 0 up to 196days
PK profile
Change of SCT520FF drug concentration in the blood with time
Time frame: Day 0 up to 196days
Cmax
The maximum blood concentration after SCT520FF drug enters the bloodstream
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EYLEA 2 MG,IVI,injection once every 4 weeks,during the study period
Time frame: Day 0 up to 196days
Tmax
Time to the Maximum Concentration of SCT520FF
Time frame: Day 0 up to 196days
PD profile
Detection of free VEGF concentration
Time frame: Day 0 up to 196 days
Immunogenicity
Positive rate of ADA and NAb
Time frame: Day 0 up to 196days