Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration

PHASE3CompletedINTERVENTIONAL
Enrollment

434

Participants

Timeline

Start Date

July 21, 2020

Primary Completion Date

June 23, 2022

Study Completion Date

May 18, 2023

Conditions
Neovascular Age-related Macular Degeneration
Interventions
DRUG

FYB203 (Proposed aflibercept biosimilar)

Patients will receive 1 IVT injection of FYB203 every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.

DRUG

Eylea® (Aflibercept)

Patients will receive 1 IVT injection of Eylea® every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.

Trial Locations (66)

Unknown

Research Site, Sofia

Research Site, Stara Zagora

Research Site, Hradec Králové

Research Site, Ostrava

Research Site, Pardubice

Research Site, Prague

Research Site, Sokolov

Research Site, Budapest

Research Site, Debrecen

Research Site, Pécs

Research Site, Szeged

Research Site, Székesfehérvár

Research Site, Tatabánya

Research Site, Zalaegerszeg

Research Site, Haifa

Research Site, Jerusalem

Research Site, Kfar Saba

Research Site, Petah Tikva

Research Site, Rehovot

Research Site, Rishon LeZiyyon

Research Site, Tel Aviv

Research Site, Bologna

Research Site, Florence

Research Site, Milan

Research Site, Roma

Research Site, Rozzano

Research Site, Udine

Research Site, Akita

Research Site, Amagasaki

Research Site, Asahikawa

Research Site, Chiyoda City

Research Site, Chūō

Research Site, Fukuoka

Research Site, Fukushima

Research Site, Hamamatsu

Research Site, Himeji

Research Site, Hirakata

Research Site, Kita-ku

Research Site, Kurume

Research Site, Meguro City

Research Site, Nagasaki

Research Site, Nagoya

Research Site, Sapporo

Research Site, Shinjuku-Ku

Research Site, Suita

Research Site, Toride

Research Site, Yokosuka

Research Site, Bielsko-Biala

Research Site, Bydgoszcz

Research Site, Krakow

Research Site, Lodz

Research Site, Olsztyn

Research Site, Tarnów

Research Site, Warsaw

Research Site, Chelyabinsk

Research Site, Kazan'

Research Site, Moscow

Research Site, Novosibirsk

Research Site, Saint Petersburg

Research Site, Kharkiv

Research Site, Kherson

Research Site, Kropyvnytskyi

Research Site, Lutsk

Research Site, Odesa

Research Site, Poltava

Research Site, Zaporizhzhya

All Listed Sponsors
lead

Bioeq GmbH

INDUSTRY

NCT04522167 - Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration | Biotech Hunter | Biotech Hunter