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KH658 is a adeno-associated virus (AAV) vector-based gene therapy for suprachoroidal space injection. The long-term, stable therapeutic protein after one time injection for nAMD could potentially reduce the treatment burden and maintain vision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KH658 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KH658 | Drug | KH658 Ophthalmic Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability and safety of KH658 in different dose levels | Week 4, Week 26 | |
| Change in BCVA letter | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events and adverse reactions | Week 4, 26, 38, 54 | |
| Efficacy (BCVA, CRT) | Week 38, 54 | |
| Number of supplemental injections |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiarong Du | Contact | +86176 0288 9310 | 026117@cnkh.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University General Hospital | Recruiting | Tianjin | China |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| Week 54 |
| Annualized rate of supplemental injections | Week 54 |
| Percentage of subjects free of rescue IVT therapy | Week 54 |