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The purpose of this study is to compare the efficacy and safety of MW02 versus Lucentis in the treatment of neovascular age-related macular degeneration.The study was divided into two stages. The first stage was to explore the dose and the second stage was to explore the frequency of administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lucentis-0.5mg(Q4w) | Active Comparator | It is administered once every 4 weeks for 48 weeks. Intravitreal injection was used, and the dose was 0.5mg. |
|
| MW02-1.0mg(Q4w) | Experimental | It is administered once every 4 weeks for 48 weeks. Intravitreal injection was used, and the dose was 1.0mg. |
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| MW02-1.5mg(Q4w) | Experimental | It is administered once every 4 weeks for 48 weeks. Intravitreal injection was used, and the dose was 1.5mg. |
|
| MW02(Q8w) | Experimental | It is administered once every 4 weeks for 3 consecutive times, and then once every 8 weeks for 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MW02 | Drug | MW02 is a recombinant anti-VEGF humanized monoclonal antibody injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Best Corrected Visual Acuity (BCVA) | Change from Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study(ETDRS) letter score at week 52. | At week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in BCVA | Change from Baseline in BCVA as measured by ETDRS letter score over the study duration. | baseline to week 52 |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ming zhang, professor | Contact | 86+18980602122 | Zhangming-yangcp@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 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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| Lucentis | Drug | a recombinant anti-VEGF humanized monoclonal antibody injection |
|
|
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |