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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 LX103 treatment of X-linked retinoschisis. This study will enroll subjects aged ≥ 6 years old to receive a single unilateral intravitreal (IVT) injection of LX103 to evaluate its safety and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LX103 Injection | Experimental | Potential doses: 5E10 vg, 0.1 mL/eye/dose (low dose) 1E11 vg, 0.05 mL/eye/dose (high dose) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LX103 Injection | Genetic | Qualified subjects will receive a single unilateral intravitreal injection of LX103 at Day 0 in the trial. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Incidence of adverse events (AEs) within 24 weeks of LX103 intravitreal injection at different doses | 24 weeks |
| Incidence of serious adverse events (SAEs) | Incidence of serious adverse events (SAEs) within 24 weeks of LX103 intravitreal injection at different doses | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in BCVA (LogMAR) in the study eye | ETDRS visual acuity charts will be used to assess BCVA | 24 weeks, 52 weeks |
| Mean change from baseline in central subfield thickness (CST) in the study eye |
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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 | Recruiting | Shanghai | 200080 | China |
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| ID | Term |
|---|---|
| D041441 | Retinoschisis |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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Mean change of CST measured using Optical Coherence Tomography (OCT)
| 24 weeks, 52 weeks |
| Change from baseline in Electroretinogram (ERG) parameters in the study eye | Change in dark-adapted 3.0 B-wave amplitude (μV) | 24 weeks, 52 weeks |