At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 705 enrolled
Drug / intervention
SB11 (Proposed ranibizumab biosimilar) +1 moredrug
Likely dose
SB11 (Proposed ranibizumab biosimilar) 0.5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity Between SB11 and Lucentis® in Subjects With Neovascular Age-related Macular Degeneration
In Brief
A Phase 3 clinical trial evaluating SB11 (Proposed ranibizumab biosimilar) and Lucentis (ranibizumab) for Age-Related Macular Degeneration. Completed, enrolled 705 participants across 75 sites in 9 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAge-Related Macular Degeneration
CountriesCzechia, Germany, Hungary, India, Poland, Russia, South Korea, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMay 2017
Enrollment StartMar 2018
Primary CompletionMay 2019
Study CompletionDec 2019
TodayJul 2026
First PostedMay 12, 2017
Enrollment StartMar 14, 2018
Primary CompletionMay 24, 2019
Study CompletionDec 9, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.1 years ago
Interventions
SB11 (Proposed ranibizumab biosimilar)drug
SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
Lucentis (ranibizumab)drug
Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks