449
Participants
Start Date
June 23, 2020
Primary Completion Date
April 15, 2021
Study Completion Date
March 16, 2022
SB15 (Proposed aflibercept biosimilar)
Subjects randomized into SB15 group will receive SB15 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48. Starting at Week 32, subjects transited from Eylea to SB15 will receive SB15 2 mg (0.05 mL) via intravitreal injection every 8 weeks.
Eylea (Aflibercept)
Subjects randomized into Eylea group will receive Eylea 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48.
SB Investigative Site, Chevy Chase
SB Investigative Site, Abilene
SB Investigative Site, Colorado Springs
SB Investigative Site, Osijek
SB Investigative Site, Rijeka
SB Investigative Site, Brno
SB Investigative Site, Hradec Králové
SB Investigative Site, Prague
SB Investigative Site, Kohtla-Järve
SB Investigative Site, Tallinn
SB Investigative Site, Budapest
SB Investigative Site, Debrecen
SB Investigative Site, Pécs
SB Investigative Site, Szeged
SB Investigative Site, Zalaegerszeg
SB Investigative Site, Aichi
SB Investigative Site, Fukuoka
SB Investigative Site, Inashiki-gun
SB Investigative Site, Kagoshima
SB Investigative Site, Nagasaki
SB Investigative Site, Osaka
SB Investigative Site, Saitama
SB Investigative Site, Tokyo
SB Investigative Site, Riga
SB Investigative Site, Bydgoszcz
SB Investigative Site, Katowice
SB Investigative Site, Krakow
SB Investigative Site, Lodz
SB Investigative Site, Tarnów
SB Investigative Site, Kovrov
SB Investigative Site, Moscow
SB Investigative Site, Novosibirsk
SB Investigative Site, Saint Petersburg
SB Investigative Site, Ansan
SB Investigative Site, Busan
SB Investigative Site, Daegu
SB Investigative Site, Seongnam
SB Investigative Site, Seoul
Samsung Bioepis Co., Ltd.
INDUSTRY