A Phase 3 Study to Compare the Efficacy and Safety of HLX04-O with Ranibizumab in Subjects with WAMD

PHASE3CompletedINTERVENTIONAL
Enrollment

410

Participants

Timeline

Start Date

July 1, 2021

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
Age Related Macular Degeneration
Interventions
DRUG

HLX04-O

Biologic recombinant anti-VEGF humanized monoclonal antibody, developed by Shanghai Henlius Biotech, Inc.

DRUG

ranibizumab

Biologic anti-VEGF recombinant humanized monoclonal antibody fragment

Trial Locations (126)

21740

Cumberland Valley Retina Consultants, Hagerstown

22042

Emerson Clinical Research Institute, Falls Church

27103

Piedmont Retina Specialists, Asheville

27332

North Carolina Retina Associates, Wake Forest

28602

Graystone Eye, Hickory

28803

Western Carolina Retinal Associates, Asheville

29414

Retina Consultants of Charleston: Charleston Neuroscience Institute, Charleston

29501

Carolina Center for Sight, Florence

29902

Retina Consultants of Charleston - Beaufort, Beaufort

30909

Southeast Retina Center, Augusta

32216

Florida Retina Institute-Orlando, Jacksonville

32806

Florida Retina Institute-Orlando, Orlando

33612

University of South Florida, Tampa

33880

Center for Retina and Macular Disease, Winter Haven

37203

Retina Consultants of Nashville, Nashville

39202

Mississippi Retina Associates, Jackson

40206

Butchertown Clinical Trials, Louisville

55416

VitreoRetinal Surgery PLLC DBA Retina Consultants of Minnesota, Saint Louis Park

55435

Retina Consultants of Minnesota, Edina

60304

Illinois Retina Associates, Oak Park

60637

The University of Chicago, IL, Chicago

The University of Chicago, Chicago

66215

Retina Associates LLC, Lenexa

77015

Mt. Olympus Research-Garcia, Houston

Mt. Olympus Research/Museum Eye District, Houston

77384

Retina Consultants of Texas, The Woodlands

77401

Retina Consultants of TEXAS- Newcastle, Bellaire

78681

Retina Consultants of TEXAS - Round Rock, Round Rock

80909

Retina Consultants of Southern Colorado, Colorado Springs

84107

Retina Associates of Utah, PLLC, Salt Lake City

Rocky Mountain Retina Consultants, Salt Lake City

85020

Associated Retina Consultants-Phoenix, Phoenix

85297

Associated Retina Consultants-Gilbert, Gilbert

90048

MACRO Trials/ Lazar Retina, Los Angeles

90505

East West Eye Institute, Torrance

90720

Retina Consultants of Orange County, Los Alamitos

90807

South Coast Retina Center, Long Beach

91204

Global Research Management, Glendale

92647

Atlantis Eyecare, VMR Institute, Huntington Beach

VMR Institute, Huntington Beach

92835

Retina Consultants of Orange County, Fullerton

97401

Verum Research, LLC, Eugene

WA 6009

Lions Eye Institute, Nedlands

Unknown

The Alfred Hospital, Melbourne

Lions Eye Institute, Nedlands

Mhat Dr. Stamen Iliev Ad, Montana

Assoc. Prof. Dr. Desislava Koleva Aipsmaed Sveti Luka Eood, Plovdiv

Dcc Aleksandrovska Eood, Sofia

Umhat Lozenets Ead, Sofia

University First Mhat - Sofia Sv. Joan Krastitel Ead, Sofia

Specialized Hospital For Active Treatment in Ophthalmology - Varna, Varna

Vizus Eood, Gorna Oryahovitsa

Specialized Eye Hospital For Active Treatment - Burgas Ltd, Burgas

Medical Center Dar Plovdiv Ltd, Plovdiv

Medical Center Vereya Ltd, Stara Zagora

Lanzhou University Second Hospital, Lanzhou

Joint Shangtou International Eye Center Of Shantou University And The Chinese University Of Hong Kong, Shantou

The Third Affiliated Hospital of Xinxiang Medical University, Xinxiang

First Hospital of Jilin University, Changchun

The People's Hospital of Ningxia Hui Autonomous Region, Yinchuan

Weifang Eye Hospital, Weifang

Shanghai First Peoples's Hospital, Shanghai

Shanxi Eye Hospital, Taiyuan

Oftex Ocni Klinika, Pardubice

Centre Hospitalier Universitaire Amiens-Picardie Service D'Ophthalmologie Amiens France, Amiens

University Eye Clinic Centre Hospitalier Creteil Paris France, Paris

Ukb University of Bonn, Bonn

University Hospital Freiburg, Freiburg im Breisgau

Justus Liebig University Giessen, Giessen

Johannes Gutenberg University Mainz, Mainz

St Franziskus Hospital Munster, Münster

Eye Clinic Sulzbach, Sulzbach

Bajcsy-Zsilinszky Korhaz Es Rendelointezet, Budapest

Semmelweis Egyetem, Budapest

Markhot Ferenc Oktatokorhaz Es Rendelointezet, Eger

Ganglion Orvosi Kozpont, Pécs

Pecsi Tudomanyegyetem Klinikai Kozpont - Szemeszeti Klinika, Pécs

Szegedi Tudomanyegyetem Aok Szakk, Szeged

Irccs Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia Onlus Rome, Italy, Rome

Clinica Oculistica Ospedale Luigi Sacco, Universita' Degli Studi Di Milano, Milan

Clinica Oculistica Universita Vita Salute - Irccs Ospedale San Raffaele, Milan

Fondazione Policlinico Universitario Agostino Gemelli - Irccs Uoc Oculistica, Rome

P Stradina Clinical University Hospital, Riga

Riga East University Hospital, Riga

Nzoz E-Vita, Bialystok

Centrum Medyczne Promed, Krakow

Oftalmika Sp Z.O.O, Bydgoszcz

Centrum Klinicke Oftalmologie S.R.O, Katowice

Szpital SW. Rozy, Krakow

Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lubline, Lublin

Szpital SW Wojciecha, Poznan

Caminomed Wojciech Jedrzejewski, Tarnowskie Góry

Centrum Medyczne Uno-Med, Tarnów

Nzoz Optimed, Warsaw

Retina Okulistyka Sp.Z O.O.Sp.K., Warsaw

Centrum Medyczne Piasta 47, Wałbrzych

Special Optalmological Hospital Belgrade, Belgrade

Zvezdara University Medical Center, Belgrade

National University Hospital, Singapore

Ocna Klinika Szu F.D.R.Banska Bystrica, Banská Bystrica

Fakultna Nemocnica Nitra, Nitra

Fakultna Nemocnica S Poliklinikou Nove Zamky Oftalmologicke Nelozkove Oddelenie, Nové Zámky

Nemocnica Poprad As Oftalmologicke Oddelenie Jzs, Poprad

Nemocnica S Poliklinikou Trebisov A.S. Ocne Oddelenie Jzs, Trebišov

Fakultna Nemocnica Trencin, Trenčianske Teplice

Fakultna Nemocnica S Poliklinikou Zilina, Žilina

VISSUM, Alicante

Centro de Oftalmologia Barraquer, Barcelona

Hospital Universitari Vall D Hebron, Barcelona

Institito de Microcirugia Ocular, Barcelona

Institut Catala de La Retina, Barcelona

Oftalvist Clinic, Burjassot

Hospital La Arruzafa, Córdoba

Hospital Clinico San Carlos, Madrid

Hospital Universitario Fundacion Jimenez Diaz, Madrid

Hospital Universitario Puerta de Hierro, Majadahonda

Instituto Oftalmologico Fernandez-Vega, Oviedo

Clinica Universitario de Navarra, Pamplona

Hospital Universitario Donostia, San Sebastián

Omiq Hospital General de Catalunya, Sant Cugat del Vallès

Hospital Universitario Virgen Macarena, Seville

Clinica Oftalmologica Aiken, Valencia

Consorcio Hospital General Universitario de Valencia, Valencia

Fisabio Oftalmologia Medica, Valencia

Hospital Rio Hortega, Valladolid

Hospital Universitario Miguel Servet, Zaragoza

All Listed Sponsors
lead

Shanghai Henlius Biotech

INDUSTRY