AzTrials
AzTrials

Diabetic Macular EdemaPhase 3Rhone-XNCT04432831

A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema

A Phase 3 study testing Faricimab in people with Diabetic Macular Edema, run by Hoffmann-La Roche at 320 sites in 30 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a multicenter long-term extension study designed to evaluate the long-term safety and tolerability of faricimab administered by intravitreal (IVT) injection at a personalized treatment interval (PTI) to participants who enrolled in and completed one of the two Phase III studies, GR40349 (NCT03622580) or… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Edema
What is being tested?
Faricimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,479 participants
Where
320 sitesin 30 countries
Study dates
5 Aug 2020to 11 Oct 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Previous enrollment in and completion of Study GR40349 (NCT03622580) or GR40398 (NCT03622593), without study or study drug discontinuation
  • Ability to comply with the study protocol, in the investigator's judgment
  • For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 3 months after the final dose of study treatment

Who cannot join

  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final intravitreal injection of faricimab
  • Presence of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of faricimab, that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
  • Presence of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of faricimab and that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications
  • History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injections, study treatment procedure, dilating drops, or any of the anesthetic and antimicrobial preparations used by a patient during the study
  • Requirement for continuous use of any medications or treatments indicated as prohibited therapy

Trial locations and contacts

320 sites in 30 countries.

320 sites in 30 countries

United States119 sites

  • Retina Consultants of Hawaii

    ‘Aiea, Hawaii, 96701

  • Retina Res Institute of Texas

    Abilene, Texas, 79606

  • Capital Region Retina

    Albany, New York, 12206

  • University of New Mexico

    Albuquerque, New Mexico, 87131

  • Western Carolina Retinal Associate PA

    Asheville, North Carolina, 28803

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • University of Colorado; dept of ophthalmology

    Aurora, Colorado, 80045

  • Austin Retina Associates

    Austin, Texas, 78705-1169

  • Austin Clinical Research LLC

    Austin, Texas, 78750

  • California Retina Consultants.

    Bakersfield, California, 93309

  • The Retina Care Center

    Baltimore, Maryland, 21209

  • Johns Hopkins Med; Wilmer Eye Inst

    Baltimore, Maryland, 21287

  • Retina & Vitreous of Texas

    Bellaire, Texas, 77401-3510

  • Retina Consultants of Texas

    Bellaire, Texas, 77401

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California, 90211

  • Tufts Medical Center; Ophthalmology

    Boston, Massachusetts, 02111

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114

  • Beetham Eye Institute, Joslin Diabetes Center

    Boston, Massachusetts, 02215

  • Uni of Vermont Medical Center;

    Burlington, Vermont, 05405

  • Retinal Diagnostic Center

    Campbell, California, 95008

  • Char Eye Ear &Throat Assoc

    Charlotte, North Carolina, 28210

  • Univ of Virginia Ophthalmology

    Charlottesville, Virginia, 22903

  • Southeastern Retina Associates Chattanooga

    Chattanooga, Tennessee, 37421

  • Midwest Vision Research Foundation

    Chesterfield, Missouri, 63017

  • Retina Group of Washington

    Chevy Chase, Maryland, 20815

  • Cincinnati Eye Institute

    Cincinnati, Ohio, 45242

  • Retina Assoc of Cleveland Inc

    Cleveland, Ohio, 44122

  • Cleveland Clinic Foundation; Cole Eye Institute

    Cleveland, Ohio, 44195-0001

  • Retina Consultants of Southern

    Colorado Springs, Colorado, 80909

  • The Ohio State University Havener Eye Institute

    Columbus, Ohio, 43212

  • Texas Retina Associates

    Dallas, Texas, 75231

  • Rand Eye

    Deerfield Beach, Florida, 33064

  • Midwest Retina

    Dublin, Ohio, 43016

  • VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota

    Edina, Minnesota, 55435

  • NJRetina

    Edison, New Jersey, 08820

  • Retina Vitreous Center

    Edmond, Oklahoma, 73013

  • The Retina Partners

    Encino, California, 91436

  • Emerson Clinical Research Institute

    Falls Church, Virginia, 22042

  • Retina Group of Florida

    Fort Lauderdale, Florida, 33308

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912

  • Eye Medical Center

    Fresno, California, 93720

  • Retina Consultants of Orange County

    Fullerton, California, 92835-3424

  • Charles Retina Institute

    Germantown, Tennessee, 38138

  • Associated Retinal Consultants

    Grand Rapids, Michigan, 49546

  • Foundation for Vision Research

    Grand Rapids, Michigan, 49546

  • Vitreo-Retinal Associates

    Grand Rapids, Michigan, 49546

  • Long Is. Vitreoretinal Consult

    Great Neck, New York, 11021

  • Retina Consultants Of Carolina

    Greenville, South Carolina, 29605

  • Cumberland Valley Retina PC

    Hagerstown, Maryland, 21740

  • Valley Retina Institute P.A.

    Harlingen, Texas, 78550

  • Long Is. Vitreoretinal Consult

    Hauppauge, New York, 11788

  • Graystone Eye

    Hickory, North Carolina, 28602

  • Midwest Eye Institute

    Indianapolis, Indiana, 46290

  • Charleston Neuroscience Inst

    Ladson, South Carolina, 29456

  • Colorado Retina Associates, PC

    Lakewood, Colorado, 80228

  • Retina Associates

    Lenexa, Kansas, 66215

  • Retina Associates of Kentucky

    Lexington, Kentucky, 40509

  • Retina Vit Surgeons/Central NY

    Liverpool, New York, 13088

  • Southern California Permanente Medical Group

    Los Angeles, California, 90027

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502

  • University of Wisconsin

    Madison, Wisconsin, 53705

  • Georgia Retina PC

    Marietta, Georgia, 30060-1137

  • Florida Eye Associates

    Melbourne, Florida, 32901

  • Barnet Dulaney Perkins Eye Center

    Mesa, Arizona, 85206

  • West Virginia University Eye Institute

    Morgantown, West Virginia, 26506

  • Northern California Retina Vitreous Associates

    Mountain View, California, 94040

  • Tennessee Retina PC

    Nashville, Tennessee, 37203

  • New York University

    New York, New York, 10017

  • Wagner Kapoor Institute

    Norfolk, Virginia, 23502

  • Retinal & Ophthalmic Cons PC

    Northfield, New Jersey, 08225

  • University Retina and Macula Associates, PC

    Oak Forest, Illinois, 60452

  • East Bay Retina Consultants

    Oakland, California, 94609

  • Ophthalmic Cons of Long Island

    Oceanside, New York, 11572

  • Retina Care Specialists

    Palm Beach Gardens, Florida, 33410

  • Southern CA Desert Retina Cons

    Palm Desert, California, 92211

  • California Eye Specialists Medical group Inc.

    Pasadena, California, 91107

  • Retina Specialty Institute

    Pensacola, Florida, 32503

  • Mid Atlantic Retina - Wills Eye Hospital

    Philadelphia, Pennsylvania, 19107

  • Mid-Atlantic Retina

    Philadelphia, Pennsylvania, 19107

  • Retinal Research Institute, LLC

    Phoenix, Arizona, 85014

  • Arizona Retina and Vitreous Consultants

    Phoenix, Arizona, 85016

  • Fort Lauderdale Eye Institute

    Plantation, Florida, 33324

  • Maine Eye Center

    Portland, Maine, 04101

  • Retina Northwest

    Portland, Oregon, 97221

  • Retina Consultants, San Diego

    Poway, California, 92064

  • Retina Consultants of Southern California

    Redlands, California, 92373

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Retina Institute of Virginia

    Richmond, Virginia, 23235

  • Retina Associates of Western New York

    Rochester, New York, 14620

  • Assoc Retinal Consultants PC

    Royal Oak, Michigan, 48073

  • Retinal Consultants Med Group

    Sacramento, California, 95825

  • Retina Associates of Utah, PLLC

    Salt Lake City, Utah, 84107

  • University of Utah; Division of Gastroenterology/Hepatology

    Salt Lake City, Utah, 84132

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240

  • West Coast Retina Medical Group

    San Francisco, California, 94109

  • Orange County Retina Med Group

    Santa Ana, California, 92705

  • California Retina Consultants

    Santa Barbara, California, 93103

  • California Retina Consultants - Santa Maria

    Santa Maria, California, 93454

  • Island Retina

    Shirley, New York, 11967

  • The Retina Consultants

    Slingerlands, New York, 12159

  • Retina Center of Texas

    Southlake, Texas, 76092

  • Prairie Eye & LASIK Center / Prairie Retina Center

    Springfield, Illinois, 62704

  • Retina Vitreous Assoc of FL

    St. Petersburg, Florida, 33711

  • Southern Vitreoretinal Assoc

    Tallahassee, Florida, 32308

  • Retina Associates of Florida, LLC

    Tampa, Florida, 33609

  • Retina Associates of NJ

    Teaneck, New Jersey, 07666

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384-4167

  • Retina Specialists

    Towson, Maryland, 21204

  • Associated Retinal Consultants, P.C.

    Traverse City, Michigan, 49686

  • Retina Associates Southwest PC

    Tucson, Arizona, 85704

  • Eye Care Assoc of East Texas

    Tyler, Texas, 75701

  • Bay Area Retina Associates

    Walnut Creek, California, 94598

  • Retina Group of New England

    Waterford, Connecticut, 06385

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266

  • Vitreo-Retinal Consultants

    Wichita, Kansas, 67214

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087

  • Wake Forest Baptist Health Eye Centre

    Winston-Salem, North Carolina, 27157

  • Vitreo-Retinal Associates, PC

    Worcester, Massachusetts, 01605

Other trials in United States

Japan23 sites

  • Sugita Eye Hospital

    Aichi, 460-0008

  • Nagoya University Hospital

    Aichi, 466-8560

  • Nagoya City University Hospital

    Aichi, 467-8602

  • Aichi Medical University Hospital

    Aichi, 480-1195

  • Toho University Sakura Medical Center

    Chiba, 285-8741

  • Hayashi Eye Hospital

    Fukuoka, 812-0011

  • Kurume University Hospital

    Fukuoka, 830-0011

  • Hokkaido University Hospital

    Hokkaido, 060-8648

  • Asahikawa Medical University Hospital

    Hokkaido, 078-8510

  • Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)

    Hyōgo, 660-8550

  • Kozawa eye hospital and diabetes center

    Ibaraki, 310-0845

  • Ideta Eye Hospital

    Kumamoto, 860-0027

  • Kyoto University Hospital

    Kyoto, 606-8507

  • Mie University Hospital

    Mie, 514-8507

  • University of Miyazaki Hospital

    Miyazaki, 889-1692

  • Nara Medical University Hospital

    Nara, 634-8522

  • Kitano Hospital

    Osaka, 530-8480

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586

  • National Defense Medical College Hospital

    Saitama, 359-8513

  • Shiga University Of Medical Science Hospital

    Shiga, 520-2192

  • Tokyo Women's Medical University

    Tokyo, 162-0054

  • Kyorin University Hospital

    Tokyo, 181-8611

  • Tokyo Medical University Hachioji Medical Center

    Tokyo, 193-0998

Other trials in Japan

Spain18 sites

  • Complejo Hospitalario Universitario Albacete; Servicio de oftalmologia

    Albacete, 02006

  • VISSUM Instituto Oftalmológico de Alicante

    Alicante, 03016

  • Centro de Oftalmologia Barraquer; Servicio Oftalmologia

    Barcelona, 08021

  • Hospital dos de maig; servicio de oftalmologia

    Barcelona, 08025

  • Hospital Clinic de Barcelona; Consultas Externas Oftalmologia

    Barcelona, 08028

  • Hospital de Santa Creu I Sant Pau; Servicio de Oftalmologia

    Barcelona, 08041

  • Oftalvist Valencia

    Burjassot, Valencia, 46100

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario de Gran Canaria; Servicio de oftalmologia

    Las Palmas de Gran Canaria, LAS Palmas, 35016

  • Clinica Baviera; Servicio Oftalmologia

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Instituto Oftalmologico Fernandez Vega; Servicio de oftalmologia

    Oviedo, Principality of Asturias, 33012

  • Clinica Universitaria de Navarra; Servicio de Oftalmologia

    Pamplona, Navarre, 31008

  • Complejo Hospitalario de Navarra; Servicio de oftalmologia

    Pamplona, Navarre, 31008

  • Hospital General de Catalunya

    Sant Cugat del Vallès, Barcelona, 08195

  • Instituto Oftalmologico Gomez Ulla; Servicio de Oftalmologia

    Santiago de Compostela, LA Coruña, 15706

  • Fisabio-Ofalmologia Medica; Servicio de Oftalmología

    Valencia, 46015

  • Hospital Universitario Rio Hortega; Servicio de Oftalmologia

    Valladolid, 47012

Other trials in Spain

Poland16 sites

  • Szpital sw. Lukasza

    Bielsko-Biala, 43-309

  • Specjalistyczny Osrodek Okulistyczny Oculomedica

    Bydgoszcz, 85-316

  • OFTALMIKA Sp. z o.o

    Bydgoszcz, 85-631

  • Szpital Specjalistyczny nr 1; Oddzial Okulistyki

    Bytom, 41-902

  • Dobry Wzrok Sp Z O O

    Gdansk, 80-402

  • Optimum Profesorskie Centrum Okulistyki

    Gdansk, 80-809

  • Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT

    Gliwice, 44-100

  • Gabinet Okulistyczny Prof Edward Wylegala

    Katowice, 40-594

  • Centrum Medyczne UNO-MED

    Krakow, 31-070

  • SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej

    Krakow, 31-501

  • Optomed Sp. z o.o.

    Rybnik, 44-203

  • Osrodek Chirurgii Oka prof. Zagorskiego Rzeszow

    Rzeszów, 35-017

  • Kliniczny Szpital Wojewodzki nr 1 im. F. Chopina; Klinika Okulistyki

    Rzeszów, 35-055

  • Caminomed

    Tarnowskie Góry, 42-600

  • Centrum Zdrowia MDM

    Warsaw, 00-189

  • SPEKTRUM Osrodek Okulistyki Klinicznej

    Wroclaw, 53-334

Other trials in Poland

United Kingdom16 sites

  • Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL

    Belfast, BT12 6BA

  • Bradford Royal Infirmary

    Bradford, BD9 6RJ

  • East Kent Hospitals University NHS Foundation Trust

    Canterbury, CT1 3NG

  • Frimley Park Hospital

    Frimley, GU16 7UJ

  • Gloucestershire Hospitals NHS Foundation Trust

    Gloucester, GL1 3NN

  • James Paget University Hospitals NHS Foundation Trust

    Great Yarmouth, Norfolk, NR31 6LA

  • St James University Hospital

    Leeds, LS9 7TF

  • Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre

    Liverpool, L7 8YE

  • Moorfields Eye Hospital NHS Foundation Trust

    London, EC1V 2PD

  • Royal Free Hospital

    London, NW3 2QS

  • Kings College Hospital

    London, SW9 8RR

  • Manchester Royal Eye Hospital

    Manchester, M13 9WL

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

  • University Hospital Southampton NHS Foundation Trust; Southampton Eye Unit

    Southampton, SO16 6YD

  • Sunderland Eye Infirmary

    Sunderland, SR2 9HP

  • Hillingdon Hospital

    Uxbridge, Middx, UB8 3NN

Other trials in United Kingdom

Germany10 sites

  • Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde

    Dresden, 01307

  • Universitätsklinikum Freiburg, Klinik für Augenheilkunde

    Freiburg im Breisgau, 79106

  • Medizinische Hochschule Hannover, Klinik für Augenheilkunde

    Hanover, 30625

  • Universitätsklinikum des Saarlandes; Klinik für Augenheilkunde

    Homburg/Saar, 66424

  • Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik

    Magdeburg, 39120

  • LMU Klinikum der Universität, Augenklinik

    München, 80336

  • Klinikum rechts der Isar der TU München; Augenklinik

    München, 81675

  • Augenabteilung am St. Franziskus-Hospital

    Münster, 48145

  • Universitätsklinikum Münster; Augenheilkunde

    Münster, 48149

  • Universitätsklinikum Würzburg, Augenklinik und Poliklinik

    Würzburg, 97080

Other trials in Germany

Hungary10 sites

  • Eszak-Pesti Centrumkorhaz - Honvedkorhaz; Szemeszet

    Budapest, 1068

  • Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR

    Budapest, 1076

  • Semmelweis Egyetem Szemészeti Vizsgálóhely

    Budapest, 1085

  • Bajcsy-Zsilinszky Hospital

    Budapest, 1106

  • Budapest Retina Associates Kft.

    Budapest, 1133

  • Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

    Debrecen, 4032

  • Ganglion Medial Center

    Pécs, 7621

  • Szegedi Tudományegyetem ÁOK; Department of Ophtalmology

    Szeged, 6720

  • Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET; Intezeti Gyogyszertar

    Szombathely, 9700

  • Zala Megyei Kórház; SZEMESZET

    Zalaegerszeg, 8900

Other trials in Hungary

Brazil9 sites

  • Hospital de Olhos de Aparecida - HOA

    Aparecida de Goiânia, Goiás, 74980-010

  • Botelho Hospital da Visao

    Blumenau, Santa Catarina, 89052-504

  • Centro Brasileiro de Cirurgia

    Goiânia, Goiás, 74210-010

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Faculdade de Medicina do ABC - FMABC

    Santo André, São Paulo, 09060-650

  • Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia

    São Paulo, São Paulo, 04023-062

  • CEMAPE - Centro Médico

    São Paulo, São Paulo, 04084-002

  • Hospital das Clinicas - FMUSP

    São Paulo, São Paulo, 05403-010

  • Hosp de Olhos de Sorocaba

    Sorocaba, São Paulo, 18031-060

Other trials in Brazil

Italy8 sites

  • Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica

    Florence, Tuscany, 50134

  • UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA

    Genoa, Liguria, 16132

  • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica

    Milan, Lombardy, 20100

  • Irccs Ospedale San Raffaele;U.O. Oculistica

    Milan, Lombardy, 20132

  • Ospedale Classificato Equiparato Sacro Cuore ? Don Calabria; Presso Ufficio Cassa

    Negrar - Verona, Veneto, 37024

  • Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia; Clinica Oculistica

    Perugia, Umbria, 06129

  • Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria

    Pisa, Tuscany, 56124

  • Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico

    Rome, Lazio, 00198

Other trials in Italy

Australia7 sites

  • Centre For Eye Research Australia

    East Melbourne, Victoria, 3002

  • The Lions Eye Institute

    Nedlands, Western Australia, 6009

  • Retina Specialists Victoria

    Rowville, Victoria, 3178

  • Strathfield Retina Clinic

    Strathfield, New South Wales, 2135

  • Sydney Eye Hospital

    Sydney, New South Wales, 2000

  • Sydney Retina Clinic and Day Surgery

    Sydney, New South Wales, 2000

  • Sydney West Retina

    Westmead, New South Wales, 2145

Other trials in Australia

Canada7 sites

  • Institut De L'Oeil Des Laurentides

    Boisbriand, Quebec, J7H 0E8

  • Calgary Retina Consultants

    Calgary, Alberta, T2J 0C8

  • QEII - HSC Department of Ophthalmology

    Halifax, Nova Scotia, B3H 2Y9

  • Ivey Eye Institute

    London, Ontario, N6A 4V2

  • Toronto Retina Institute

    Toronto, Ontario, M3C 0G9

  • St. Michael's Hospital; Department of Ophthalmology

    Toronto, Ontario, M5C 2T2

  • University Health Network Toronto Western Hospital

    Toronto, Ontario, M5T 2S9

Other trials in Canada

Russia7 sites

  • Intersec Research and Technology Complex ?Eye Microsurgery? n.a. S.N. Fyodorov; Cheboksary Branch

    Cheboksary, Mariy-El Republic, 428000

  • ?Intersec. Research and Technology Complex ?Eye Microsurgery? n a Fyodorov Irkutsk branch

    Irkutsk, 664033

  • Clinics of Eye Diseases, LLC

    Kazan', Tatarstan Republic, 420066

  • FSBI ?Scientific Research Institute of Eye Diseases? of Russian Academy of medical Sciences

    Moscow, Moscow Oblast, 119435

  • ?Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch

    Novosibirsk, 630096

  • Medical Military Academy n.a S.M.Kirov

    Saint Petersburg, Sankt-Peterburg, 124044

  • Clinic Optimed

    Ufa, Bashkortostan Republic, 450059

Other trials in Russia

Turkey (Türkiye)7 sites

  • Hacettepe University Medical Faculty; Department of Ophthalmology

    Ankara, 06100

  • Ankara University Medical Faculty; Department of Ophthalmology

    Ankara, 06340

  • Ankara Baskent University Medical Faculty; Department of Ophthalmology

    Ankara, 06490

  • Beyoglu Goz Training and Research Hospital; Department Of Ophthalmology

    Istanbul, 34421

  • Ege University Medical Faculty; Department of Ophthalmology

    Izmir, 35100

  • Kocaeli Üniversitesi T?p Fakültesi; Department of Ophthalmology

    Kocaeli, 41380

  • Selcuk University Faculty of Medicine; Department Of Ophthalmology

    Konya, 42130

Other trials in Turkey (Türkiye)

Argentina6 sites

  • Fundacion Zambrano

    CABA, C1017AAO

  • Oftalmos

    Capital Federal, C1120AAN

  • Oftar

    Mendoza, M5500GGK

  • Centro Oftalmólogos Especialistas

    Rosario, S2000ANJ

  • Grupo Laser Vision

    Rosario, S2000DLA

  • Organizacion Medica de Investigacion

    San Nicolás, C1015ABO

Other trials in Argentina

France6 sites

  • Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin

    Bordeaux, 33076

  • Chi De Creteil; Ophtalmologie

    Créteil, 94010

  • Pole Vision Val d'Ouest; Ophtalmologie

    Écully, 69130

  • CHU Nantes - Hôtel Dieu; Ophthalmology

    Nantes, 44093

  • Hopital Lariboisiere; Ophtalmologie

    Paris, 75010

  • Centres Ophtalmologique St Exupéry; Ophtalmologie

    Saint-Cyr-sur-Loire, 37540

Other trials in France

Czechia5 sites

  • FN Hradec Králové, Ocní klinika; Ophthalmology clinic

    Hradec Králové, 500 05

  • Faculty Hospital Ostrava; Ophthalmology clinic

    Ostrava, 708 52

  • Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic

    Prague, 100 34

  • AXON Clinical

    Prague

  • Nemocnice Sokolov

    Sokolov, 356 01

Other trials in Czechia

Israel5 sites

  • Rambam Medical Center; Opthalmology

    Haifa, 3109601

  • Hadassah MC; Ophtalmology

    Jerusalem, 9112001

  • Rabin MC; Ophtalmology

    Petah Tikva, 4941492

  • Kaplan Medical Center; Ophtalmology

    Rehovot, 7660101

  • Tel Aviv Sourasky MC; Ophtalmology

    Tel Aviv, 6423906

Other trials in Israel

South Korea5 sites

  • Seoul National University Bundang Hospital

    Seongnam-si, 463-707

  • Kyung Hee University Hospital

    Seoul, 02447

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Austria4 sites

  • LKH-Univ.Klinikum Graz; Universitäts-Augenklinik

    Graz, 8036

  • Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde

    Linz, 4021

  • Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

    Vienna, 1090

  • Hanusch Krankenhaus; Abteilung für Augenkrankheiten mit Augen-Tagesklinik

    Vienna, 1140

Other trials in Austria

Bulgaria4 sites

  • Medical Center for Eye Health ? Focus Ltd

    Sofia, 1303

  • Pentagram Eye Hospital (Medical Center "Pentagram")

    Sofia, 1309

  • Spec. Ophth. Hospital for Active Treatment- Academic Pashev

    Sofia, 1517

  • Specialized Hospital for Active Treatment of Eye Diseases Zora

    Sofia, 1784

Other trials in Bulgaria

Mexico4 sites

  • Centro Oftalmológico Mira, S.C

    Del. Cuauhtemoc, Mexico CITY (federal District), 06760

  • Macula Retina Consultores

    México, Mexico CITY (federal District), 01120

  • Hospital de la Ceguera APEC

    México, Mexico CITY (federal District), 04030

  • Instituto de la retina del Bajio

    Querétaro City, Querétaro, 76180

Other trials in Mexico

Portugal4 sites

  • Hospital de Braga; Servico de Oftalmologia

    Braga, 4710-243

  • AIBILI - Association for Innovation and Biomedical Research on Light

    Coimbra, 3000-548

  • Espaco Medico Coimbra

    Coimbra, 3030-163

  • Hospital de Santa Maria; Servico de Oftalmologia

    Lisbon, 1649-035

Other trials in Portugal

Peru3 sites

  • Mácula D&T

    Lima, 27

  • TG Laser Oftalmica

    Lima, 27

  • Oftalmolaser

    Lima, Lima 33

Other trials in Peru

Singapore3 sites

  • National University Hospital; Ophthalmology Department

    Singapore, 119074

  • Singapore Eye Research Institute

    Singapore, 168751

  • Tan Tock Seng Hospital; Ophthalmology Department

    Singapore, 308433

Other trials in Singapore

Slovakia3 sites

  • Nemocnica s poliklinikou Trebišov, a.s.

    Trebišov, 075 01

  • Fakultna nemocnica Trencin Ocna klinika

    Trenčín, 911 71

  • Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie

    Žilina, 012 07

Other trials in Slovakia

Taiwan3 sites

  • Taipei Veterans General Hospital; Ophthalmology

    Taipei, 11217

  • Chang Gung Medical Foundation - Linkou; Ophthalmology

    Taoyuan, 333

  • National Taiwan University Hospital; Ophthalmology

    Zhongzheng Dist., 10002

Other trials in Taiwan

Thailand3 sites

  • King Chulalongkorn Memorial Hospital; Ophthalmology Department

    Bangkok, 10330

  • Rajavithi Hospital; Ophthalmology Department

    Bangkok, 10400

  • Maharaj Nakorn ChiangMai Hospital; Ophthalmology Department

    Chiang Mai, 50200

Other trials in Thailand

Denmark2 sites

  • Aalborg Universitetshospital; Øjenafdelingen

    Aalborg, 9000

  • Sjællands Universitetshospital, Roskilde; Øjenafdelingen

    Roskilde, 4000

Other trials in Denmark

Hong Kong2 sites

  • Queen Mary Hospital; Department of Ophthalmology

    Hong Kong

  • Hong Kong Eye Hospital; CUHK Eye Centre

    Mong Kok

Other trials in Hong Kong

Switzerland1 site

  • Vista Klinik Ophthalmologische Klinik

    Binningen, 4102

Other trials in Switzerland

About this study

Official title: A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients With Diabetic Macular Edema

This is a multicenter long-term extension study designed to evaluate the long-term safety and tolerability of faricimab administered by intravitreal (IVT) injection at a personalized treatment interval (PTI) to participants who enrolled in and completed one of the two Phase III studies, GR40349 (NCT03622580) or GR40398 (NCT03622593), also referred to as the parent studies.

Being tested
Faricimab, Sham Procedure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FaricimabDrug

    Also called RO6867461, RG7716

    Faricimab will be administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen.

  • Sham ProcedureOther

    The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. The sham procedure will be administered to participants as appropriate during the first 16 weeks of this study in order to maintain the masking of the initial faricimab PTI.

Study groups in NCT04432831
Study groupRoleWhat they receive
Faricimab PTIExperimentalNot described
Receives: Drug: Faricimab; Other: Sham Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale

    This is an analysis of participants with at least one ocular adverse event (AE) that occurred in the study eye. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of the seriousness, severity (e.g., mild, moderate, or severe intensity), and causality for each AE. AEs of special interest (AESI) included the following: Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, are associated with severe intraocular inflammation (IOI), or require surgical or medical intervention to prevent permanent loss of sight; suspected transmission of an infectious agent by the study drug; and, cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law.

    Measured: From the day of the first dose of faricimab until the end of the study (up to 108 weeks)

  2. Incidence of Ocular Adverse Events in the Fellow Eye

    This is an analysis of participants with at least one ocular adverse event (AE) that occurred in the fellow eye (i.e., non-study eye). Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of the seriousness, severity, and causality for each AE. AEs of special interest (AESI) included the following: Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, are associated with severe intraocular inflammation (IOI), or require surgical or medical intervention to prevent permanent loss of sight; suspected transmission of an infectious agent by the study drug; and, cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law.

    Measured: From the day of the first dose of faricimab until the end of the study (up to 108 weeks)

  3. Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale

    This is an analysis of participants with at least one non-ocular (systemic) adverse event (AE). Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of the seriousness, severity (e.g., mild, moderate, or severe intensity), and causality for each AE. AEs of special interest (AESI) included the following: Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, are associated with severe intraocular inflammation (IOI), or require surgical or medical intervention to prevent permanent loss of sight; suspected transmission of an infectious agent by the study drug; and, cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law.

    Measured: From the day of the first dose of faricimab until the end of the study (up to 108 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2020
  2. Study start5 Aug 2020
  3. Primary completion11 Oct 2023
  4. Study completion11 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,479 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04432831
Sponsor's protocol ID
GR41987
Other IDs
2020-000402-29
Acronym
Rhone-X
Status last verified
Jan 2026
First submitted
12 Jun 2020
Last updated
9 Feb 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Publications

  • Sheth VS, Schlottmann P, Lai TYY, Abreu F, Chang A, Eter N, Gibson K, Hu AY, Korobelnik JF, Kotak A, Kotecha A, O'Leary OE, Pearce I, Sim DA, Sun JK, Tang Y, Khanani AM. Four-Year Outcomes of Faricimab in Diabetic Macular Edema: Results from the RHONE-X Extension Trial. Ophthalmology. 2026 May;133(5):599-612. doi: 10.1016/j.ophtha.2026.01.001. Epub 2026 Jan 12.

    PubMed 41534798

  • Sheth VS, Vujosevic S. Four-Year Outcomes of Faricimab in Diabetic Macular Edema in the RHONE-X Extension Trial: A Podcast. Ophthalmol Ther. 2026 Aug 20. doi: 10.1007/s40123-026-01470-6. Online ahead of print.

    PubMed 42622958

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Faricimab in people with Diabetic Macular Edema, run by Hoffmann-La Roche at 320 sites in 30 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 320 sites in United States, Japan, Spain, Poland, United Kingdom and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale (time frame: From the day of the first dose of faricimab until the end of the study (up to 108 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04432831, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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