KH658 is a adeno-associated virus (AAV) vector-based gene therapy for suprachoroidal space injection. The long-term, stable therapeutic protein after one time injection for nAMD could potentially reduce the treatment burden and maintain vision.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
KH658 Ophthalmic Injection
Tianjin Medical University General Hospital
Tianjin, China
RECRUITINGTolerability and safety of KH658 in different dose levels
Time frame: Week 4, Week 26
Change in BCVA letter
Time frame: Week 26
Incidence of adverse events and adverse reactions
Time frame: Week 4, 26, 38, 54
Efficacy (BCVA, CRT)
Time frame: Week 38, 54
Number of supplemental injections
Time frame: Week 54
Annualized rate of supplemental injections
Time frame: Week 54
Percentage of subjects free of rescue IVT therapy
Time frame: Week 54
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