At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 600 enrolled
Drug / intervention
LUBT010 (proposed ranibizumab biosimilar) +1 moredrug
Likely dose
LUBT010 (proposed ranibizumab biosimilar) 0.5 mgfrom 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 Global, Phase III, Double Blind, Randomized Controlled Study to Compare the Efficacy, Safety & Immunogenicity of LUBT010 With Lucentis® in Patients With Neovascular Age Related Macular Degeneration
In Brief
A Phase 3 clinical trial evaluating LUBT010 (proposed ranibizumab biosimilar) and Lucentis (ranibizumab) for Neovascular Age-related Macular Degeneration. Completed, enrolled 600 participants across 78 sites in 7 countries.
Detailed Summary
This study is designed to compare the efficacy, safety and immunogenicity of LUBT010 with Lucentis® given as once monthly intravitreal injection in patients with neovascular age-related macular degeneration (AMD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria, Hungary, India, Poland, Russia, Slovakia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
Enrollment StartSep 2020
First PostedDec 2020
Primary CompletionMay 2024
TodayJul 2026
First PostedDec 30, 2020
Enrollment StartSep 14, 2020
Primary CompletionMay 31, 2024
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 5.5 years ago
Interventions
LUBT010 (proposed ranibizumab biosimilar)drug
LUBT010 (proposed ranibizumab biosimilar) 0.5 mg via intravitreal injection once monthly
Lucentis (ranibizumab)drug
Lucentis® 0.5 mg via intravitreal injection once monthly