A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration

NCT ID: NCT04777201

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1036 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-19
• Study Completion Date: 2024-09-03

Brief Summary

This main long-term extension study is designed to evaluate the long-term safety and tolerability of faricimab 6 milligrams (mg) administered by intravitreal injection at a personalized treatment interval (PTI) to participants with neovascular age-related macular degeneration (nAMD) who enrolled in and completed one of the Phase III studies: GR40306 (NCT03823287) or GR40844 (NCT03823300), also referred to as the parent studies. Eligible patients who consent to participate in this main study will be enrolled upon completion of the end-of-study visit in the parent study.

Additionally, there is a substudy that is being conducted. The aim of this substudy is to evaluate the impact of intravitreal faricimab on the health of the corneal endothelial cells in the study eyes of patients with nAMD to fulfill a U.S. Food and Drug Administration (FDA) post-marketing requirement. The fellow eyes of the same enrolled participants in the substudy will serve as the controls.

Conditions

Neovascular Age-related Macular Degeneration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Main Study: Faricimab PTI

Group Type: EXPERIMENTAL

Faricimab

Intervention Type: DRUG

Faricimab 6 mg will be administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study.

Sham Procedure

Intervention Type: OTHER

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 12 weeks of this study in order to maintain the masking of the initial faricimab PTI.

Anti-VEGF Therapy

Intervention Type: DRUG

At the discretion of the principal investigator, participants were allowed to have their fellow (non-study) eye treated with the standard of care anti-VEGF therapy (if needed) according to region-specific anti-VEGF prescribing information for the recommended dose and frequency of treatment.

Substudy: Faricimab PTI

Group Type: EXPERIMENTAL

Faricimab

Intervention Type: DRUG

Faricimab 6 mg will be administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study.

Anti-VEGF Therapy

Intervention Type: DRUG

At the discretion of the principal investigator, participants were allowed to have their fellow (non-study) eye treated with the standard of care anti-VEGF therapy (if needed) according to region-specific anti-VEGF prescribing information for the recommended dose and frequency of treatment.

Interventions

Faricimab

Faricimab 6 mg will be administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study.

Intervention Type: DRUG

Sham Procedure

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 12 weeks of this study in order to maintain the masking of the initial faricimab PTI.

Intervention Type: OTHER

Anti-VEGF Therapy

At the discretion of the principal investigator, participants were allowed to have their fellow (non-study) eye treated with the standard of care anti-VEGF therapy (if needed) according to region-specific anti-VEGF prescribing information for the recommended dose and frequency of treatment.

Intervention Type: DRUG

Other Intervention Names

RO6867461; RG7716

Eligibility Criteria

Inclusion Criteria

• Previous enrollment in and completion of Study GR40306 (NCT03823287) or Study GR40844 (NCT03823300), without study or study drug discontinuation
• For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs. Women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 3 months after the final dose of faricimab. Women must refrain from donating eggs during the same period.

• Sign an informed consent form for the Substudy
• Must be able to participate for at least 48 weeks in the Substudy and have at least the first visit while enrolled in the main Study GR42691
• A difference of <10% in corneal endothelial cell density at screening between the two eyes as measured by specular microscopy and determined by the independent reading center

Exclusion Criteria

• Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose 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-related procedure preparations, 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

• Prior and/or current administration of faricimab in the fellow (non-study) eye
• Prior administration of brolucizumab in the fellow (non-study) eye

• Corneal endothelial cell density ≤1500 cells/mm2 in either eye at screening as determined by the independent corneal reading center
• Fuchs endothelial corneal dystrophy Grade ≥2
• Previous ocular trauma (blunt or penetrating) and/or corneal endothelial cell damage, including from blunt or surgical trauma (including complicated cataract surgery resulting in complicated lens placement such as anterior chamber intraocular lens, sulcus intraocular lens, aphakia, etc.)
• Any ocular condition that precludes obtaining an analyzable specular microscopy image
• Active or history of corneal edema
• Any active or history of corneal dystrophies, excluding Fuchs endothelial corneal dystrophy Grade <2
• Active or history of iridocorneal endothelial syndrome
• Active or history of pseudoexfoliation syndrome
• Active or history of herpetic keratitis or kerato-uveitis (including herpes simplex virus and herpes zoster virus)
• Intraocular laser therapy including selective laser trabeculoplasty, yttrium-aluminum garnet (YAG), prophylactic peripheral iridotomy within 1 year of screening, or YAG capsulotomy within 3 months of screening
• Prior vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
• Prior pars plana vitrectomy surgery
• Previous intraocular device implantation excluding intraocular lenses
• Cataract surgery within 6 months of screening or planned for during the study
• History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery. Other types of prior glaucoma surgery are allowed providing that the surgery occur more than 6 months before screening
• Administration of topical Rho kinase inhibitors (e.g., Rhopressa eye drops) within 1 month prior to the screening visit
• Contact lens wear in either eye within 2 months of screening
• History of corneal transplantation, including partial-thickness corneal grafts (e.g., Descemet membrane endothelial keratoplasty, Descemet stripping endothelial keratoplasty)
• Active or history of iridocorneal endothelial syndrome
• Active or history of pseudoexfoliation syndrome

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Barnet Dulaney Perkins Eye Center

Mesa, Arizona, United States

Arizona Retina and Vitreous Consultants

Phoenix, Arizona, United States

Associated Retina Consultants

Phoenix, Arizona, United States

Retina Associates Southwest PC

Tucson, Arizona, United States

Retinal Diagnostic Center

Campbell, California, United States

The Retina Partners

Encino, California, United States

South Coast Retina Center

Los Angeles, California, United States

Northern California Retina Vitreous Associates

Mountain View, California, United States

Southern CA Desert Retina Cons

Palm Desert, California, United States

California Eye Specialists Medical group Inc.

Pasadena, California, United States

Retina Consultants, San Diego

Poway, California, United States

Retina Consultants of Southern California

Redlands, California, United States

University of California, Davis, Eye Center

Sacramento, California, United States

Retinal Consultants Med Group

Sacramento, California, United States

Orange County Retina Med Group

Santa Ana, California, United States

California Retina Consultants

Santa Barbara, California, United States

Retina Consultants of Southern

Colorado Springs, Colorado, United States

Colorado Retina Associates, PC

Lakewood, Colorado, United States

Retina Group of New England

Waterford, Connecticut, United States

Rand Eye

Deerfield Beach, Florida, United States

Retina Group of Florida

Fort Lauderdale, Florida, United States

Florida Eye Associates

Melbourne, Florida, United States

Retina Care Specialists

Palm Beach Gardens, Florida, United States

Retina Specialty Institute

Pensacola, Florida, United States

Fort Lauderdale Eye Institute

Plantation, Florida, United States

Retina Vitreous Assoc of FL

St. Petersburg, Florida, United States

Southern Vitreoretinal Assoc

Tallahassee, Florida, United States

Retina Associates of Florida, LLC

Tampa, Florida, United States

Southeast Retina Center

Augusta, Georgia, United States

Georgia Retina PC

Marietta, Georgia, United States

Retina Consultants of Hawaii

‘Aiea, Hawaii, United States

Northwestern Medical Group/Northwestern University

Chicago, Illinois, United States

University Retina and Macula Associates, PC

Oak Forest, Illinois, United States

Prairie Retina Center

Springfield, Illinois, United States

Raj K. Maturi, MD PC

Indianapolis, Indiana, United States

Wolfe Eye Clinic

West Des Moines, Iowa, United States

Retina Associates

Lenexa, Kansas, United States

Maine Eye Center

Portland, Maine, United States

Retina Specialists

Baltimore, Maryland, United States

The Retina Care Center

Baltimore, Maryland, United States

Johns Hopkins Med

Baltimore, Maryland, United States

Retina Group of Washington

Chevy Chase, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

VitreoRetinal Surgery, PLLC.

Edina, Minnesota, United States

Midwest Vision Research Foundation

Chesterfield, Missouri, United States

Retina Associates of St. Louis

Florissant, Missouri, United States

Sierra Eye Associates

Reno, Nevada, United States

Mid Atlantic Retina - Wills Eye Hospital

Cherry Hill, New Jersey, United States

NJ Retina

Edison, New Jersey, United States

Retina Associates of NJ

Teaneck, New Jersey, United States

Long Is. Vitreoretinal Consult

Great Neck, New York, United States

Ophthalmic Cons of Long Island

Oceanside, New York, United States

Retina Assoc of Western NY

Rochester, New York, United States

Vitreoretinal Consultants of New York

Shirley, New York, United States

The Retina Consultants

Slingerlands, New York, United States

Retina Vit Surgeons/Central NY

Syracuse, New York, United States

Western Carolina Retinal Associate PA

Asheville, North Carolina, United States

Char Eye Ear &Throat Assoc

Charlotte, North Carolina, United States

Graystone Eye

Winston-Salem, North Carolina, United States

Cincinnati Eye Institute

Blue Ash, Ohio, United States

Retina Assoc of Cleveland Inc

Cleveland, Ohio, United States

The Ohio State University Havener Eye Institute

Columbus, Ohio, United States

Midwest Retina

Dublin, Ohio, United States

Retina Northwest

Portland, Oregon, United States

Charleston Neuroscience Inst

Ladson, South Carolina, United States

Palmetto Retina Center

West Columbia, South Carolina, United States

Black Hills Eye Institute

Rapid City, South Dakota, United States

Southeastern Retina Associates Chattanooga

Chattanooga, Tennessee, United States

Charles Retina Institute

Germantown, Tennessee, United States

Tennessee Retina PC.

Nashville, Tennessee, United States

Retina Res Institute of Texas

Abilene, Texas, United States

Austin Retina Associates

Austin, Texas, United States

Austin Clinical Research LLC

Austin, Texas, United States

Texas Retina Associates

Dallas, Texas, United States

Retina Consultants of Texas

Houston, Texas, United States

Valley Retina Institute P.A.

McAllen, Texas, United States

Retina Center of Texas

Southlake, Texas, United States

Retina Consultants of Houston

The Woodlands, Texas, United States

Strategic Clinical Research Group, LLC

Willow Park, Texas, United States

Retina Associates of Utah, PLLC

Salt Lake City, Utah, United States

Rocky Mountain Retina

Salt Lake City, Utah, United States

Piedmont Eye Center

Lynchburg, Virginia, United States

Wagner Kapoor Institute

Norfolk, Virginia, United States

Pacific Northwest Retina

Silverdale, Washington, United States

Organizacion Medica de Investigacion

Buenos Aires, , Argentina

Fundacion Zambrano

CABA, , Argentina

Centro Oftalmologico Dr. Charles S.A.

Capital Federal, , Argentina

Oftalmos

Capital Federal, , Argentina

Buenos Aires Mácula

Ciudad Autonoma Buenos Aires, , Argentina

Oftar

Mendoza, , Argentina

Grupo Laser Vision

Rosario, , Argentina

Eyeclinic Albury Wodonga

Albury, New South Wales, Australia

Sydney Eye Hospital

Sydney, New South Wales, Australia

Sydney Retina Clinic and Day Surgery

Sydney, New South Wales, Australia

Sydney West Retina

Westmead, New South Wales, Australia

Centre For Eye Research Australia

East Melbourne, Victoria, Australia

Retina Specialists Victoria

Rowville, Victoria, Australia

The Lions Eye Institute

Nedlands, Western Australia, Australia

LKH-Univ.Klinikum Graz

Graz, , Austria

Medizinische Universitat Wien

Vienna, , Austria

Hospital de Olhos de Aparecida - HOA

Aparecida de Goiânia, Goiás, Brazil

Universidade Federal de Sao Paulo - UNIFESPX

São Paulo, São Paulo, Brazil

Pentagram Eye Hospital (Medical Center "Pentagram")

Sofia, , Bulgaria

Specialized Hospital for Active Treatment of Eye Diseases Zora

Sofia, , Bulgaria

Calgary Retina Consultants

Calgary, Alberta, Canada

University of British Columbia - Vancouver Coastal Health Authority

Vancouver, British Columbia, Canada

Ivey Eye Institute

London, Ontario, Canada

Retina Institute of Ottawa

Ottawa, Ontario, Canada

Toronto Retina Institute

Toronto, Ontario, Canada

Institut De L'Oeil Des Laurentides

Boisbriand, Quebec, Canada

Michel Giunta Clinique Medical

Sherbrooke, Quebec, Canada

Rigshospitalet Glostrup

Glostrup Municipality, , Denmark

Sjællands Universitetshospital, Roskilde

Roskilde, , Denmark

Chi De Creteil

Créteil, , France

Pole Vision Val d'Ouest

Écully, , France

Hopital de la croix rousse

Lyon, , France

Centre Paradis Monticelli

Marseille, , France

CHU Nantes - Hotel Dieu

Nantes, , France

Hopital Lariboisiere

Paris, , France

Universitatsklinikum Koln

Cologne, , Germany

Universitätkslinikum Düsseldorf, Augenklinik

Düsseldorf, , Germany

Universitätsklinikum Freiburg, Klinik für Augenheilkunde

Freiburg im Breisgau, , Germany

Universitätsklinik Heidelberg

Heidelberg, , Germany

Augenabteilung am St. Franziskus-Hospital

Münster, , Germany

Universitatsklinikum Munster

Münster, , Germany

The University of Hong Kong

Hong Kong, , Hong Kong

Hong Kong Eye Hospital

Mong Kok, , Hong Kong

Eszak-Pesti Centrumkorhaz - Honvedkorhaz

Budapest, , Hungary

Bajcsy-Zsilinszky Hospital

Budapest, , Hungary

Budapest Retina Associates Kft.

Budapest, , Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecem, , Hungary

Ganglion Medial Center

Pécs, , Hungary

Szegedi Tudományegyetem ÁOK

Szeged, , Hungary

Zala Megyei Kórház

Zalaegerszeg, , Hungary

Rambam Medical Center

Haifa, , Israel

Hadassah MC

Jerusalem, , Israel

Rabin MC

Petah Tikva, , Israel

Kaplan Medical Center

Rehovot, , Israel

Tel Aviv Sourasky MC

Tel Aviv, , Israel

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

Rome, Lazio, Italy

Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena

Milan, Lombardy, Italy

Asst Fatebenefratelli Sacco

Milan, Lombardy, Italy

Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello

Pisa, Tuscany, Italy

Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia

Perugia, Umbria, Italy

Nagoya University Hospital

Aichi, , Japan

Nagoya City University Hospital

Aichi, , Japan

Aichi Medical University Hospital

Aichi, , Japan

Daiyukai Daiichi Hospital

Aichi, , Japan

Chiba University Hospital

Chiba, , Japan

Toho University Sakura Medical Center

Chiba, , Japan

Hayashi Eye Hospital

Fukuoka, , Japan

Kurume University Hospital

Fukuoka, , Japan

Sapporo City General Hospital

Hokkaido, , Japan

Asahikawa Medical University Hospital

Hokkaido, , Japan

Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)

Hyōgo, , Japan

Hyogo Medical University Hospital

Hyōgo, , Japan

Kozawa eye hospital and diabetes center

Ibaraki, , Japan

Kagawa University Hospital

Kagawa, , Japan

Kagoshima University Hospital

Kagoshima, , Japan

Ideta Eye Hospital

Kumamoto, , Japan

Kyoto University Hospital

Kyoto, , Japan

Mie University Hospital

Mie, , Japan

Fukushima Medical University Hospital

Miyagi, , Japan

University of Miyazaki Hospital

Miyazaki, , Japan

Shinshu University Hospital

Nagano, , Japan

Iida Municipal Hospital

Nagano, , Japan

Japanese Red Cross Nagasaki Genbaku Hospital

Nagasaki, , Japan

Nara Medical University Hospital

Nara, , Japan

University of the Ryukyus Hospital

Okinawa, , Japan

Kitano Hospital

Osaka, , Japan

Osaka Metropolitan University Hospital

Osaka, , Japan

Kansai Medical University Medical Center

Osaka, , Japan

Kansai Medical University Hospital

Osaka, , Japan

National Defense Medical College Hospital

Saitama, , Japan

Shiga University Of Medical Science Hospital

Shiga, , Japan

Nihon University Hospital

Tokyo, , Japan

Tokyo Women's Medical University Hospital

Tokyo, , Japan

Kyorin University Hospital

Tokyo, , Japan

Tokyo Medical University Hachioji Medical Center

Tokyo, , Japan

Yamaguchi University Hospital

Yamaguchi, , Japan

Centro Oftalmológico Mira, S.C

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

Macula Retina Consultores

Mexico City, Mexico CITY (federal District), Mexico

Montemayor & Asociados (Oftalmologos)

Monterrey Nuevo LEON, Nuevo León, Mexico

Het Oogziekenhuis Rotterdam

Rotterdam, , Netherlands

Szpital sw. Lukasza

Bielsko-Biala, , Poland

OFTALMIKA Sp. z o.o

Bydgoszcz, , Poland

Specjalistyczny O?rodek Okulistyczny Oculomedica

Bydgoszcz, , Poland

Szpital Specjalistyczny nr 1

Bytom, , Poland

Dobry Wzrok Sp Z O O

Gda?sk, , Poland

Optimum Profesorskie Centrum Okulistyki

Gda?sk, , Poland

Gabinet Okulistyczny Prof Edward Wylegala

Katowice, , Poland

Centrum Medyczne Dietla 19 Sp. Z O.O.

Krakow, , Poland

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

Krakow, , Poland

Caminomed

Tarnowskie Góry, , Poland

SPEKTRUM Osrodek Okulistyki Klinicznej

Wroclaw, , Poland

Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia

Coimbra, , Portugal

Hospital de Sao Joao

Porto, , Portugal

Intersec Research and Technology Complex ?Eye Microsurgery? n.a. S.N. Fyodorov

Cheboksary, Mariy-El Republic, Russia

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

Moscow, Moscow Oblast, Russia

Medical Military Academy n.a S.M.Kirov

Saint Petersburg, Sankt-Peterburg, Russia

1 Saint-Petersburg St. Med. University named after academician I.P.Pavlov

Saint Petersburg, Sankt-Peterburg, Russia

Clinics of Eye Diseases, LLC

Kazan', Tatarstan Republic, Russia

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

Novosibirsk, , Russia

Singapore Eye Research Institute

Singapore, , Singapore

Pusan National University Hospital

Busan, , South Korea

Yeungnam University Medical Center

Daegu, , South Korea

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Samsung Medical Center

Seoul, , South Korea

Kyung Hee University Hospital

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Nune Eye Hospital

Seoul, , South Korea

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital General de Catalunya

San Cugat Del Valles, Barcelona, Spain

Instituto Oftalmologico Gomez Ulla

Santiago de Compostela, LA Coruna, Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

Instituto Oftalmologico Fernandez Vega

Oviedo, Principality of Asturias, Spain

Oftalvist Valencia

Burjassot, Valencia, Spain

Institut de la Macula i la retina

Barcelona, , Spain

Hospital dos de maig

Barcelona, , Spain

Hospital Clinic de Barcelona

Barcelona, , Spain

Clinica Baviera

Madrid, , Spain

Hospital Universitario Rio Hortega

Valladolid, , Spain

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Vista Klinik Ophthalmologische Klinik

Binningen, , Switzerland

Changhua Christian Hospital

Changhua, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Chang Gung Medical Foundation - Linkou

Taoyuan District, , Taiwan

Hacettepe University Medical Faculty

Ankara, , Turkey (Türkiye)

Ankara University Medical Faculty

Ankara, , Turkey (Türkiye)

Ankara Baskent University Medical Faculty

Ankara, , Turkey (Türkiye)

Gazi University Faculty of Medicine

Ankara, , Turkey (Türkiye)

Ege University Medical Faculty

Izmir, , Turkey (Türkiye)

Kocaeli University Medical Faculty

Kocaeli, , Turkey (Türkiye)

Selcuk University Faculty of Medicine

Konya, , Turkey (Türkiye)

Opthalmology Research Office

Bradford, , United Kingdom

Bristol Eye Hospital

Bristol, , United Kingdom

University Hospital of Wales

Cardiff, , United Kingdom

Frimley Park Hospital

Frimley, , United Kingdom

Gloucestershire Hospitals NHS Foundation Trust

Gloucestershire, , United Kingdom

Hull Royal Infirmary

Hull, , United Kingdom

St James University Hospital

Leeds, , United Kingdom

Royal Liverpool University Hospital

Liverpool, , United Kingdom

Moorfields Eye Hospital NHS Foundation Trust

London, , United Kingdom

Manchester Royal Eye Hospital

Manchester, , United Kingdom

Royal Victoria Infirmary

Newcastle upon Tyne, , United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, , United Kingdom

New Cross Hospital

Wolverhampton, , United Kingdom

The York Hospital

York, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Brazil; Bulgaria; Canada; Denmark; France; Germany; Hong Kong; Hungary; Israel; Italy; Japan; Mexico; Netherlands; Poland; Portugal; Russia; Singapore; South Korea; Spain; Switzerland; Taiwan; Turkey (Türkiye); United Kingdom

Provided Documents

Document Type: Study Protocol: Main Study

View Document

Document Type: Study Protocol: CEC Substudy

View Document

Document Type: Statistical Analysis Plan: Main Study

View Document

Document Type: Statistical Analysis Plan: CEC Substudy

View Document

Other Identifiers

2020-004523-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GR42691

Identifier Type: -

Identifier Source: org_study_id