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| Name | Class |
|---|---|
| Fountain Medical Development Co., Ltd. | INDUSTRY |
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This is an open label dose-escalation study to evaluate the safety and treatment benefits of MS-553 in treatment-naive diabetic retinopathy patients with central involved macular edema. Fifteen subjects with diabetic macular edema will be enrolled into each of three dose cohorts and will receive oral administration of MS-553 for 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MS-553 low dose | Experimental | low dose of MS-553 taken orally |
|
| MS-553 mid dose | Experimental | mid dose of MS-553 taken orally |
|
| MS-553 high dose | Experimental | high dose of MS-553 taken orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MS-553 | Drug | MS-553 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent adverse events | Baseline to Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in the central retina subfield thickness (CRT) | Baseline to Day 56 | |
| Mean change in the retinal volume | Baseline to Day 56 | |
| Proportion of patients with >20% reduction in CRT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ling Yang | Contact | +8613421382136 | yangling@relin.cn |
| Name | Affiliation | Role |
|---|---|---|
| Kai Zhang, MD | Shenzhen MingSight Relin Pharmaceuticals Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | China | ||
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| Baseline to Day 56 |
| Proportion of patients with resolution of central involved macular edema | Baseline to Day 56 |
| Average mean change in best corrected visual acuity | Baseline to Day 56 |
| West China Hospital of Sichuan University |
| Recruiting |
| Chengdu |
| Sichuan |
| China |
| Shanghai General Hospital | Recruiting | Shanghai | 200080 | China |
|
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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