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This trial is to evaluate the safety and efficacy of JWK002 treatment of X-linked retinoschisis(XLRS). This study will enroll subjects aged 5-18 years old to receive a sub-retinal injection of JWK002.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JWK002 at Low Dose Group | Experimental | Subretinal injection low dose of JWK002 in one eye |
|
| JWK002 at Medium Dose Group | Experimental | Subretinal injection medium dose of JWK002 in one eye |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JWK002 | Drug | Subretinal administration of gene therapy vector JWK002 to one eye. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety(Participants With Ocular and Non-ocular AEs (Adverse Events) and SAEs (Serious Adverse Events) | The primary outcome measures are safety, determined by the number of ocular and non-ocular Study Drug-related adverse events (SDAE), treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). | baseline to day 7, day 14, month 1, 3, 6, 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity (BCVA) | Visual acuity of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) | baseline to day 7, day 14, month 1, 2, 3, 6, 12 |
| Full-field electroretinogram(ff-ERG) |
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Inclusion Criteria:
Exclusion Criteria:
(14) Other situations that the investigator considers inappropriate for participation in this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Licong Liang | Contact | 932968425@qq.com | ||
| Kaiqin She | Contact | shekaiqin@wchscu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Fang Lu | lufang@wchscu.cn | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital | Recruiting | Chengdu | Sichuan | 610023 | China |
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| ID | Term |
|---|---|
| D041441 | Retinoschisis |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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The ERG measurement will be performed based on the standards of international society for clinical electrophysiology of vision (ISCEV).
| baseline to month 1, 3, 6, 12 |
| Macular structure as assessed by swept source optical coherence tomography | Change in swept source optical coherence tomography(SS-OCT) | baseline to month 1, 3, 6, 12 |
| Visual field | Change in visual field assessed by Humphrey perimetry | baseline to month 1, 3, 6, 12 |