This is a long-term, safety and efficacy follow-up study of patients in the EXG102-031-111 gene therapy clinical trial for wAMD. Patients will complete visits from the parent study, and then into this long-term follow-up study for continuous safety monitoring for up to 5 years.
This study will enroll patients with wet age-related macular degeneration (wAMD) who have previously be treated with EXG102-031 injection, those patients will Voluntary join this long-term follow-up study to be evaluated the long-term safety and efficacy. The first two years of long-term follow-up will be conducted every 2 months; From 3 years to 5 years after administration,follow-up visits will be conducted every six months.
Study Type
OBSERVATIONAL
Enrollment
42
No intervention, only for observational studies
Peking University People's Hospital
Beijing, China
RECRUITINGlong-term safety：the types, severity, and incidence of serious adverse events (SAEs), adverse events (AEs).
the types, severity, and incidence of serious adverse events (SAEs), adverse events (AEs).
Time frame: 4 years
Change from baseline after treatment by EXG102-031：best corrected visual acuity (BCVA)
Use the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart evaluated. The higher values means better outcome.
Time frame: 4 years
Change from baseline after treatment by EXG102-031：central retinal thickness (CRT)
evaluated by Spectral Domain Optical Coherence Tomography (SD-OCT). The higher values means worse outcome.
Time frame: 4 years
The times of receiving anti-vascular endothelial growth factor (VEGF) therapy after EXG102-031 administrated
The more times means worse outcome
Time frame: 4 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.