Efficacy and Safety of the Biosimilar Ranibizumab FYB201 in Comparison to Lucentis in Patients With Neovascular Age-related Macular Degeneration (COLUMBUS-AMD)
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|ClinicalTrials.gov Identifier: NCT02611778|
Recruitment Status : Completed
First Posted : November 23, 2015
Last Update Posted : January 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Age-related Macular Degeneration (AMD)||Biological: ranibizumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy and Safety of the Biosimilar Ranibizumab FYB201 in Comparison to Lucentis in Patients With Neovascular Age-related Macular Degeneration|
|Study Start Date :||February 2016|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||June 8, 2018|
FYB201 is provided as single use vials and will be administered by intra‐vitreal injection.
Active Comparator: Lucentis
Lucentis® is provided as single use vials and will be administered by intra‐vitreal injection.
- Change from baseline in BCVA by ETDRS letters after 2 months (8 weeks) of treatment [ Time Frame: 2 months ]To evaluate and compare functional changes in best corrected visual acuity (BCVA) after 2 months (8 weeks) of treatment with FYB201 or Lucentis, compared to baseline BCVA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02611778
|University of Bonn, Department of Ophthalmology|
|Principal Investigator:||Frank G. Holz, Prof. Dr.||University of Bonn, Department of Ophthalmology|