A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Phase 3
Completed
NCT03150589
| Condition | Age-Related Macular Degeneration |
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| Phase | Phase 3 |
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| Sponsor | Samsung Bioepis Co., Ltd. |
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| Status | Completed |
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| Enrollment | 705 participants |
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| Interventions | SB11 (Proposed ranibizumab biosimilar), Lucentis (ranibizumab) |
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| Start date | Mar 14, 2018 |
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| Completion date | May 24, 2019 |
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| Results posted | May 21, 2021 |
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Summary
This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB11 compared to Lucentis® in subjects with neovascular AMD.
Change From Baseline in Best Corrected Visual Acuity (BCVA)
Baseline and Week 8 · letters
| SB11 (Proposed Ranibizumab Biosimilar) | 6.26 ± 0.51 letters |
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| Lucentis (Ranibizumab) | 7.08 ± 0.51 letters |
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Change From Baseline in Central Subfield Thickness (CST)
Baseline and Week 4 · μm
| SB11 (Proposed Ranibizumab Biosimilar) | -108.40 ± 4.65 μm |
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| Lucentis (Ranibizumab) | -100.05 ± 4.64 μm |
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Open in BENITIONS
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