At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 712 enrolled
Drug / intervention
ranibizumabbiological
Likely dose
Not stated in 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.
Efficacy and Safety of the Biosimilar Ranibizumab FYB201 in Comparison to Lucentis in Patients With Neovascular Age-related Macular Degeneration
In Brief
A Phase 3 clinical trial evaluating ranibizumab for Age-related Macular Degeneration (AMD). Completed, enrolled 712 participants across 58 sites in 12 countries.
Detailed Summary
The purpose of this study is to determine the efficacy and safety of the biosimilar ranibizumab FYB201 in comparison to Lucentis in patients with neovascular age-related macular degeneration.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAge-related Macular Degeneration (AMD)
CountriesAustria, Czechia, France, Germany, Hungary, Israel, Italy, Poland, Russia, Spain, Ukraine, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 2015
Enrollment StartDec 2015
Primary CompletionDec 2017
Study CompletionJun 2018
TodayJul 2026
First PostedNov 23, 2015
Enrollment StartDec 19, 2015
Primary CompletionDec 1, 2017
Study CompletionJun 6, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 10.6 years ago
Interventions
ranibizumabbiological