Multicenter, open-label, multi-dose study to evaluate the safety and tolerability in patients with nAMD treated with SCT520FF.
Signed informed consent form.
Age≥45 years, ≤80 years，male or femal.
The study eye must meet the following criteria: Diagnosis of nAMD;Active MNV lesions secondary to nAMD; Total area of all types of lesions ≤12 optic disc areas; BCVA of the study eye 73~19 letters.
Macular-related retinal pigment epithelial tears in the study eye; scar, fibrosis, atrophy or dense subfoveal exudation involving the fovea in the study eye.
Significant APD or opacity of the refractive medium and miosis in the study eye that affect visual acuity or fundus examination.
Aphakia (except intraocular lens) or posterior capsular rupture of the lens in the study eye.
The study eye has any eye diseases or medical history other than nAMD that may affect central vision and/or macular examine.
Parallel
SCT520FF
DrugSCT520FF dose level 1，IVI
SCT520FF
DrugSCT520FF dose level 2，IVI
SCT520FF
DrugSCT520FF dose level 3，IVI
EYLEA 2 MG
DrugEYLEA 2 MG,IVI,injection once every 4 weeks,during the study period
Treatment emergent adverse events(TEAE)
Incidence of treatment emergent adverse events
Treatment-related treatment emergent adverse events(TRAE)
Incidence of treatment-related treatment emergent adverse events
Serious adverse event(SAE)
Incidence of serious adverse event
Adverse event of special interest(AESI)
Incidence of adverse event of special interest
Best corrected visual acuity(BCVA)
Mean change from baseline in BCVA
central retina thickness(CRT)
Mean change from baseline in CRT
PK profile
Change of SCT520FF drug concentration in the blood with time
Cmax
The maximum blood concentration after SCT520FF drug enters the bloodstream
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Sinocelltech Ltd.
Lead sponsor
Tianjin Medical University Eye Hospital
Collaborator
