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| Name | Class |
|---|---|
| Peking University People's Hospital | OTHER |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention, only for observational studies | Other | No intervention, only for observational studies |
| Measure | Description | Time Frame |
|---|---|---|
| long-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). | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 years |
| Change from baseline after treatment by EXG102-031:central retinal thickness (CRT) |
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Inclusion Criteria:
Exclusion Criteria:
1. Paticipantes are unwilling or unable to participate in long-term follow-up
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wAMD patients who have previously been treated with EXG102-031 injection in the study (EXG102-031-111).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Yang, MD | Contact | +86 13957164092 | sarayang@exegenesisbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Mingwei ZHAO, PhD | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D012847 | Single Person |
| ID | Term |
|---|---|
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
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evaluated by Spectral Domain Optical Coherence Tomography (SD-OCT). The higher values means worse outcome. |
| 4 years |
| The times of receiving anti-vascular endothelial growth factor (VEGF) therapy after EXG102-031 administrated | The more times means worse outcome | 4 years |
| D012959 |
| Socioeconomic Factors |