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| Name | Class |
|---|---|
| Innostellar Biotherapeutics Co.,Ltd | INDUSTRY |
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The goal of this study is to evaluate the safety and efficacy of LX111 treatment of nAMD. This study will enroll subjects aged ≥ 50 vears old to receive a single unilateral intravitreal (lVT) injection of LX111 to evaluate its safety and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LX111 intravitreal injections | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LX111 Injection | Genetic | Qualified subjects will receive a single unilateral intravitreal injection of LX111 at Day 0. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and serious adverse events in the eyes and throughout the body within 364 days after LX111 treatment | Incidence of adverse events and serious adverse events within 52 weeks of LX111 intravitreal injection in each dose group. | 52 weeks |
| Dose Limiting Toxicity | The incidence of DLT in each dose group. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean changes in BCVA from Baseline | The mean changes of BCVA scores on the ETDRS chart at different timepoints after LX111 treatment compared with baseline. | 12 weeks, 36 weeks, 52 weeks |
| Mean changes in Central Subfield Thickness (CST) from Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | 200080 | China |
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The mean changes of CST at different timepoints after LX111 treatment compared with baseline.
| 12 weeks, 36 weeks, 52 weeks |
| The percentage of subjects who received anti-VEGF supplemental injection within 52 weeks after LX111 treatment | The proportion of subjects who received anti-VEGF supplemental injection within 52 weeks after LX111 treatment | 52 weeks |