Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
VEGF inhibitors (anti-VEGF),such as aflibercept has been shown to be safe and effective for treating nAMD and have demonstrated improvement in vision. However, anti-VEGF therapy is administered frequently via intravitreal injection and can be a significant burden to the patients.
EXG 202 is a recombinant adeno-associated virus (rAAV) gene therapy vector carrying a coding sequence for a soluble anti-VEGF protein. The long-term, stable delivery of this therapeutic protein following a 1 time gene therapy treatment for nAMD could potentially reduce the treatment burden of currently available therapies while maintaining vision with a favorable benefit.
This Phase I/II study was designed to evaluate the safety and Preliminary Efficacy of EXG202 gene therapy in subjects with nAMD. Subjects who met the inclusion/exclusion criteria and had response to an initial anti-VEGF injection received a single dose of EXG202 administered . Safety was the primary focus for the phase I/II trial ,at the same time ,preliminary Efficacy also is another goal for the trial.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation-Cohort 1 | Experimental | Dose 1 :Administered via intravitreal injection |
|
| Dose escalation-Cohort 2 | Experimental | Dose 2 :Administered via intravitreal injection |
|
| Dose escalation-Cohort 3 | Experimental | Dose 3 :Administered via intravitreal injection |
|
| Dose escalation-Cohort 4 | Experimental | Dose 4 :Administered via intravitreal injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXG202 injection | Biological | EXG202 injection is a gene therapy product for the treatment of wet (neovascular) Age-related Macular Degeneration(wAMD) with a single intravitreal injection and administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability after EXG202 injection | Type, severity, and incidence of adverse events (AEs) and serious adverse events (SAEs) from Week 0 to 52, and dose limited toxicity | Up to 52 weeks after treatment |
| Preliminary Efficancy after EXG202 injection | The Best Corrected Visual Acuity (BCVA) change from baseline | Up to 52 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability after EXG202 injection | Type, severity, and incidence of adverse events (AEs) and serious adverse events (SAEs) from Week 0 to 24, and dose limited toxicity | Up to 24 weeks after treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Yang | Contact | 13957164092 | sarayang@exegenesisbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Mingwei ZHAO, PhD | Peking University People's Hospital | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided