NCT02036723

Safety and Efficacy Study of BCD-021 Compared to Lucentis® in Patients With Neovascular Wet Age-related Macular Degeneration

Multicentre Double Blind Randomized Clinical Study Evaluating The Efficacy and Safety of BCD-021 (CJSC BIOCAD, Russia) and Lucentis® (Novartis Pharmaceuticals Canada Inc.) in Patients With Neovascular Wet Age-related Macular Degeneration

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Biocad · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

GALATIR is a double blind randomized clinical trial comparing efficacy and safety of BCD-021 (bevacizumab) and Lucentis® (ranibizumab) in patients with neovascular wet age-related macular degeneration. The purpose of the study is to demonstrate the non-inferiority of efficacy and safety of BCD-021 compared to Lucentis®.

Conditions

• Wet Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Bevacizumab	Patients will receive bevacizumab at a dose 1.25 mg (in 0.05 ml of solution) as an intravitreal injection on day 1 and then every 28 days during 12 months.
DRUG	Ranibizumab	Patients will receive ranibizumab at a dose 0.50 mg (in 0.05 ml of solution) as an intravitreal injection on day 1 and then every 28 days during 12 months.

Timeline

• Primary completion: 2016-03-01
• First posted: 2014-01-15
• Last updated: 2016-03-31

Locations

13 sites across 2 countries: Brazil, Russia