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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
SKG0106 is a recombinant adeno-associated virus (AAV) vector-based in vivo gene therapeutic product
Retina Vitreous Associates of Florida - Saint Petersburg
St. Petersburg, Florida, United States
NOT_YET_RECRUITINGOphthalmic Consultants of Boston
Boston, Massachusetts, United States
RECRUITINGRetina Consultants of Texas
Characteristics of dose limiting toxicities (DLTs)
Time frame: 4 Weeks
Type, severity, and incidence of ocular and systemic adverse events (AEs)
Time frame: 52 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: 52 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: 52 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: 52 Weeks
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Katy, Texas, United States
Wagner Kapoor Research Institute
Norfolk, Virginia, United States
RECRUITINGThe Second Hospital Of Anhui Medical University
Hefei, Anhui, China
RECRUITINGZhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
RECRUITINGEye Hospital, WMU (Zhejiang Eye Hospital)
Wenzhou, Zhejiang, China
RECRUITINGBeijing Hospital
Beijing, China
RECRUITINGPeking Union Medical College Hospital
Beijing, China
RECRUITING