A Study to Compare SB15 (Proposed Aflibercept Biosimilar) to Eylea in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Phase 3
Completed
NCT04450329
| Condition | Neovascular 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 | 449 participants |
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| Interventions | SB15 (Proposed aflibercept biosimilar), Eylea (Aflibercept) |
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| Start date | Jun 23, 2020 |
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| Completion date | Apr 15, 2021 |
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| Results posted | Feb 5, 2024 |
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Summary
This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy, safety, Pharmacokinetics (PK), and immunogenicity of SB15 compared to Eylea® in subjects with neovascular AMD.
Change From Baseline in Best Corrected Visual Acuity (BCVA)
Baseline and Week 8 · letters
| SB15 (Proposed Aflibercept Biosimilar) | 6.7 ± 0.56 letters |
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| Eylea (Aflibercept) | 6.6 ± 0.57 letters |
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Open in BENITIONS
View on ClinicalTrials.gov
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