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| Name | Class |
|---|---|
| Innostellar Biotherapeutics | UNKNOWN |
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The goal of this study is to evaluate the safety and efficacy of LX102-C01 treatment of nAMD. This study will enroll subjects aged ≥ 50 years old to receive a single unilateral intravitreal (IVT) injection of LX102-C01 to evaluate its safety and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LX102-C01 Injection | Experimental | Potential doses: 3E10 vg, 0.06 mL/eye/dose 1E11 vg, 0.06 mL/eye/dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LX102-C01 Injection | Genetic | Qualified subjects will receive a single unilateral intravitreal injection of LX102-C01 at Day 0 in the trial. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Incidence of adverse events (AEs) within 52 weeks of LX102-C01 intravitreal injection at different doses | 52 weeks |
| Incidence of serious adverse events (SAEs) | Incidence of serious adverse events (SAEs) within 52 weeks of LX102-C01 intravitreal injection at different doses | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in BCVA from Baseline | BCVA measured by ETDRS | 24 weeks, 52weeks |
| Mean change in Central Subfield Thickness (CST) from Baseline | To evaluate the effect of LX102-C01 on CST |
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Inclusion Criteria:
1. Willing to sign the informed consent, and willing to attend follow-up visits.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | 200080 | China |
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| 24 weeks, 52 weeks |
| Mean number of anti-VEGF injections over time | Mean number of anti-VEGF injections over time | 52 weeks |
| Change of quality of life scores (VFQ-25) from Baseline | Changes of VFQ-25 questionaire from Baseline to 52 weeks | 52 weeks |