The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of intravitreal injection of EXG202 in subjects with neovascular age-related Macular Degeneration (nAMD).
EXG 202 is a gene therapy product developed for the treatment of neovascular age-related macular degeneration (nAMD). Neovascular AMD is the main cause of blindness among elderly individuals. The available therapies for treating nAMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. Administration of EXG202 has the potential to treat nAMD by providing durable expression of therapeutic levels of intraocular protein and maintaining the vision of patients. EXG 202 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
EXG202 is a gene therapy product for the treatment of wet (neovascular) age-related macular degeneration(wAMD) with a single intravitreal injection and administration.
Hebei Eye Hospital
Xingtai, Hebei, China
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, China
Safety and tolerability after EXG202 injection
Frequency, type, and intensity of ocular and non-ocular Adverse Events (AEs) and serious adverse events (SAE) at Week 52, to explore the maximum tolerated dose (MTD)
Time frame: up to 52 weeks after treatment
To evaluate the efficacy after EXG202 injection
the Best Corrected Visual Acuity (BCVA) change from baseline
Time frame: up to 52 weeks after treatment
To evaluate the efficacy after EXG202 injection
The optical coherence tomography (OCT ).
Time frame: 52 weeks following EXG202 treatment.
Lifei Wang, Ph.D
CONTACT
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