This is a phase 1/2 clinical study to evaluate the safety, preliminary efficacy, immunogenicity, and pharmacokinetic (PK) characteristics of SKG0106 in subjects with nAMD. Based on results from the phase 1 dose escalation study, the phase 2 expansion study will be conducted.
Voluntary and able to sign a dated ICF prior to any study-related procedures and able to complete the study as required by the protocol;
Aged ≥ 50 years at screening;
Diagnosis of nAMD as determined by the PI;
Active CNV lesions secondary to age-related macular degeneration (AMD);
Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in the study eye at baseline;
Retinal pigment epithelial tear in the study eye at screening;
Current vitreous hemorrhage in the study eye or history of vitreous hemorrhage within 4 weeks prior to baseline;
Any condition that, in the opinion of the investigator, may limit visual acuity improvement in the study eye;
Single group
SKG0106
GeneticSKG0106 is a recombinant adeno-associated virus (AAV) vector-based in vivo gene therapeutic product
Characteristics of dose limiting toxicities (DLTs)
Type, severity, and incidence of ocular and systemic adverse events (AEs)
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.
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).
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.
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