Phase 3
Completed N=705
A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Source: ClinicalTrials.gov NCT03150589 ↗Enrolled (actual)
705
Serious AEs
14.8%
Results posted
May 2021
Primary outcomePrimary: Change From Baseline in Best Corrected Visual Acuity (BCVA) — 6.26; 7.08 letters
◆ Published Evidence
Established
81citations · ~16 / year
Efficacy and Safety of a Proposed Ranibizumab Biosimilar Product vs a Reference Ranibizumab Product for Patients With Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial.
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.
Linked Publications (2)
-
Efficacy and Safety of a Proposed Ranibizumab Biosimilar Product vs a Reference Ranibizumab Product for Patients With Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial.
-
Immunogenicity With Ranibizumab Biosimilar SB11 (Byooviz) and Reference Product Lucentis and Association With Efficacy, Safety, and Pharmacokinetics: A Post Hoc Analysis of a Phase 3 Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Best Corrected Visual Acuity (BCVA) |
6.26; 7.08 | — |
| PRIMARY Change From Baseline in Central Subfield Thickness (CST) |
-108.40; -100.05 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 50 years
- Newly diagnosed, active subfoveal choroid neovascularisation (CNV) lesion secondary to AMD in the study eye
- BCVA of 20/40 to 20/200 in the study eye
- Written informed consent form
Exclusion Criteria
- Any previous ITV anti-vascular endothelial growth factor (anti-VEGF) treatment to treat neovascular AMD in either eye
- Presence of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture or pathologic myopia
- Any concurrent macular abnormality other than AMD in the study eye
Data sourced from ClinicalTrials.gov (NCT03150589) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.