This is a clinical study to evaluate the safety, preliminary efficacy, immunogenicity of SKG0106 in subjects with nAMD.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
SKG0106 is a recombinant adeno-associated virus (AAV) vector-based in vivo gene therapeutic product
Peking Union Medical College Hospital
Beijing, China
Eye & ENT Hospital of Fudan University
Shanghai, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineXin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
Characteristics of dose limiting toxicities (DLTs)
Time frame: 4 weeks
Type, severity, and incidence of ocular and systemic adverse events (AEs)
Time frame: 48 weeks
Mean change from baseline in best corrected visual acuity (BCVA) at each visit BCVA of the study eye is examined by the Early Treatment of Diabetic Retinopathy Study (ETDRS) testing at screening and baseline.
Time frame: 24 weeks
Mean change from baseline in central subfield thickness (CST) at each visit Spectral domain optical coherence tomography (SD-OCT) will be performed to measure CST at screening and at each visit (prior to study drug injection, if available).
Time frame: 24 weeks
Mean change from baseline in patient-reported outcome (VFQ-25) scale score at each visit Both the total scale and subscale scores of the VFQ-25 is ranging from 0 to 100, and higher scores mean a better outcome.
Time frame: 48 weeks
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