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The purpose of the TSL-TCM-SHJSMW-Ⅲ study is to study the efficacy and safety of Sanhuang Jingshiming Pills in subjects with Neovascular Age-Related Macular Degeneration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Sanhuang Jingshiming Pills,1 sachet/dose, bid |
|
| Placebo Group | Placebo Comparator | Placebo,1 sachet/dose, bid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sanhuang Jingshiming/Pills placebo | Drug | Ranibizumab: 1 dose/study eye (Screening/Baseline), then PRN injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with ranibizumab injections | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean number of ranibizumab injections | 24 weeks | |
| Mean days between second ranibizumab injection and baseline | 24 weeks | |
| Change in BCVA from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rui Liu | Contact | 022-86343626 | liurui383@taslypharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | China |
|
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 24 weeks |
| Proportion of participants with BCVA decrease ≥5/≥10/≥15 letters | 24 weeks |
| Change in lesion site thickness | 24 weeks |
| Change in CRT from baseline | 24 weeks |
| Proportion of participants with new macular hemorrhage | 24 weeks |
| Change in maximum macular hemorrhage area | 24 weeks |
| Change in NEI VFQ-25 score from baseline | The Visual Function Questionnaire 25(NEI VFQ-25) has a maximum score of 100 and a minimum score of 0. The higher the score, the better vision. | 24 weeks |
| Change in TCM syndrome score from baseline | There are a total of 5 projects in Traditional Chinese Medicine syndrome scale. The scale has a maximum score of 15 and a minimum score of 0. The higher the score, the more severe the disease. | 24 weeks |
| Change in individual TCM syndrome score items from baseline | There are a total of 5 projects in Traditional Chinese Medicine syndrome scale. which 2 primary symptoms scored from 0 to 6 points,and 3 secondary symptoms scored from 0 to 1 point. The higher the score, the more severe the disease. | 24 weeks |
| Proportion of participants by TCM syndrome efficacy | (clinical cure/marked effect/effective/ineffective) | 24 weeks |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |