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The purpose of this study is to compare the efficacy and safety of SCT510A versus Lucentis in the treatment of wet age-related macular degeneration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCT510A | Experimental | SCT510A(1.25mg), Vitreous injection, injection once every 4 weeks |
|
| Ranibizumab | Active Comparator | Ranibizumab(0.5mg), Vitreous injection, injection once every 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | ranibizumab,0.5mg,IVT |
| |
| SCT510A |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in BCVA at at Week 48 | Change from Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study(ETDRS) letter score at week 48. | up to at Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients gaining at least 5,10,15 letters in the BCVA at Week 12, 24 and 48 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. | up to Week 12, 24 and 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Guo | Contact | +86-10-58628288-9127 | ming_guo@sinocelltech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital | Recruiting | Beijing | China |
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| Drug |
SCT510A,1.25mg,IVT |
|
| Mean change from baseline in BCVA at at Week 12 and 24 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. | up to Week 12 and 24 |
| Mean change from baseline in CRT on OCT at Week 12, 24 and 48 (as measured by the Reading Center) | up to Week 12,24 and 48 |
| Mean change from baseline in size of CNV and total area of fluorescein leakage from CNV on FA at Week 12 and 48 (as measured by the Reading Center) | up to Week 12 and 48 |
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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