Wet Age-related Macular Degeneration
Conditions
Keywords
AAV, wAMD
Brief summary
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.
Detailed description
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.
Interventions
No intervention, only for observational studies
Sponsors
Peking University People's Hospital
Hangzhou Jiayin Biotech Ltd
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Previously received treatment with EXG102-031 in the study (EXG102-031-111); 2. Paticipantes are informed consent and willingness to follow protocol procedures.
Exclusion criteria
1\. Paticipantes are unwilling or unable to participate in long-term follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| long-term safety：the types, severity, and incidence of serious adverse events (SAEs), adverse events (AEs). | 4 years | the types, severity, and incidence of serious adverse events (SAEs), adverse events (AEs). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline after treatment by EXG102-031：best corrected visual acuity (BCVA) | 4 years | Use the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart evaluated. The higher values means better outcome. |
| Change from baseline after treatment by EXG102-031：central retinal thickness (CRT) | 4 years | evaluated by Spectral Domain Optical Coherence Tomography (SD-OCT). The higher values means worse outcome. |
| The times of receiving anti-vascular endothelial growth factor (VEGF) therapy after EXG102-031 administrated | 4 years | The more times means worse outcome |
Countries
China
Contacts
Primary ContactSara Yang, MD
Outcome results
None listed