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

NCT ID: NCT04432831

Last Updated: 2024-10-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1479 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-05

Study Completion Date

2023-10-11

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Macular Edema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The first 16 weeks of this study will be a masked period (to transition from the multi-arm parent studies) during which participants may receive either faricimab or sham injection. Participants and physicians will be masked only to the faricimab treatment interval. After the Week 16 treatment procedure, this study will follow an open-label design. The BCVA examiner will remain masked for the duration of this long-term extension study.

Study Groups

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Faricimab PTI

Group Type EXPERIMENTAL

Faricimab

Intervention Type DRUG

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

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

Interventions

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Faricimab

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

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

Intervention Type OTHER

Other Intervention Names

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RO6867461 RG7716

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Barnet Dulaney Perkins Eye Center

Mesa, Arizona, United States

Site Status

Retinal Research Institute, LLC

Phoenix, Arizona, United States

Site Status

Arizona Retina and Vitreous Consultants

Phoenix, Arizona, United States

Site Status

Retina Associates Southwest PC

Tucson, Arizona, United States

Site Status

California Retina Consultants.

Bakersfield, California, United States

Site Status

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

Site Status

Retinal Diagnostic Center

Campbell, California, United States

Site Status

The Retina Partners

Encino, California, United States

Site Status

Eye Medical Center

Fresno, California, United States

Site Status

Retina Consultants of Orange County

Fullerton, California, United States

Site Status

Southern California Permanente Medical Group

Los Angeles, California, United States

Site Status

Northern California Retina Vitreous Associates

Mountain View, California, United States

Site Status

East Bay Retina Consultants

Oakland, California, United States

Site Status

Southern CA Desert Retina Cons

Palm Desert, California, United States

Site Status

California Eye Specialists Medical group Inc.

Pasadena, California, United States

Site Status

Retina Consultants, San Diego

Poway, California, United States

Site Status

Retina Consultants of Southern California

Redlands, California, United States

Site Status

Retinal Consultants Med Group

Sacramento, California, United States

Site Status

West Coast Retina Medical Group

San Francisco, California, United States

Site Status

Orange County Retina Med Group

Santa Ana, California, United States

Site Status

California Retina Consultants

Santa Barbara, California, United States

Site Status

California Retina Consultants - Santa Maria

Santa Maria, California, United States

Site Status

Bay Area Retina Associates

Walnut Creek, California, United States

Site Status

University of Colorado; dept of ophthalmology

Aurora, Colorado, United States

Site Status

Retina Consultants of Southern

Colorado Springs, Colorado, United States

Site Status

Colorado Retina Associates, PC

Lakewood, Colorado, United States

Site Status

Retina Group of New England

Waterford, Connecticut, United States

Site Status

Rand Eye

Deerfield Beach, Florida, United States

Site Status

Retina Group of Florida

Fort Lauderdale, Florida, United States

Site Status

National Ophthalmic Research Institute

Fort Myers, Florida, United States

Site Status

Florida Eye Associates

Melbourne, Florida, United States

Site Status

Retina Care Specialists

Palm Beach Gardens, Florida, United States

Site Status

Retina Specialty Institute

Pensacola, Florida, United States

Site Status

Fort Lauderdale Eye Institute

Plantation, Florida, United States

Site Status

Retina Vitreous Assoc of FL

St. Petersburg, Florida, United States

Site Status

Southern Vitreoretinal Assoc

Tallahassee, Florida, United States

Site Status

Retina Associates of Florida, LLC

Tampa, Florida, United States

Site Status

Southeast Retina Center

Augusta, Georgia, United States

Site Status

Georgia Retina PC

Marietta, Georgia, United States

Site Status

Retina Consultants of Hawaii

‘Aiea, Hawaii, United States

Site Status

University Retina and Macula Associates, PC

Oak Forest, Illinois, United States

Site Status

Prairie Eye & LASIK Center / Prairie Retina Center

Springfield, Illinois, United States

Site Status

Midwest Eye Institute

Indianapolis, Indiana, United States

Site Status

Wolfe Eye Clinic

West Des Moines, Iowa, United States

Site Status

Retina Associates

Lenexa, Kansas, United States

Site Status

Vitreo-Retinal Consultants

Wichita, Kansas, United States

Site Status

Retina Associates of Kentucky

Lexington, Kentucky, United States

Site Status

Maine Eye Center

Portland, Maine, United States

Site Status

The Retina Care Center

Baltimore, Maryland, United States

Site Status

Johns Hopkins Med; Wilmer Eye Inst

Baltimore, Maryland, United States

Site Status

Retina Group of Washington

Chevy Chase, Maryland, United States

Site Status

Cumberland Valley Retina PC

Hagerstown, Maryland, United States

Site Status

Retina Specialists

Towson, Maryland, United States

Site Status

Tufts Medical Center; Ophthalmology

Boston, Massachusetts, United States

Site Status

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Site Status

Beetham Eye Institute, Joslin Diabetes Center

Boston, Massachusetts, United States

Site Status

Vitreo-Retinal Associates, PC

Worcester, Massachusetts, United States

Site Status

Associated Retinal Consultants

Grand Rapids, Michigan, United States

Site Status

Foundation for Vision Research

Grand Rapids, Michigan, United States

Site Status

Vitreo-Retinal Associates

Grand Rapids, Michigan, United States

Site Status

Assoc Retinal Consultants PC

Royal Oak, Michigan, United States

Site Status

Associated Retinal Consultants, P.C.

Traverse City, Michigan, United States

Site Status

VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota

Edina, Minnesota, United States

Site Status

Midwest Vision Research Foundation

Chesterfield, Missouri, United States

Site Status

Sierra Eye Associates

Reno, Nevada, United States

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NJRetina

Edison, New Jersey, United States

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Retinal & Ophthalmic Cons PC

Northfield, New Jersey, United States

Site Status

Retina Associates of NJ

Teaneck, New Jersey, United States

Site Status

University of New Mexico

Albuquerque, New Mexico, United States

Site Status

Capital Region Retina

Albany, New York, United States

Site Status

Long Is. Vitreoretinal Consult

Hauppauge, New York, United States

Site Status

Retina Vit Surgeons/Central NY

Liverpool, New York, United States

Site Status

New York University

New York, New York, United States

Site Status

Ophthalmic Cons of Long Island

Oceanside, New York, United States

Site Status

Retina Associates of Western New York

Rochester, New York, United States

Site Status

Island Retina

Shirley, New York, United States

Site Status

The Retina Consultants

Slingerlands, New York, United States

Site Status

Western Carolina Retinal Associate PA

Asheville, North Carolina, United States

Site Status

Char Eye Ear &Throat Assoc

Charlotte, North Carolina, United States

Site Status

Graystone Eye

Hickory, North Carolina, United States

Site Status

Wake Forest Baptist Health Eye Centre

Winston-Salem, North Carolina, United States

Site Status

Cincinnati Eye Institute

Cincinnati, Ohio, United States

Site Status

Retina Assoc of Cleveland Inc

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Foundation; Cole Eye Institute

Cleveland, Ohio, United States

Site Status

The Ohio State University Havener Eye Institute

Columbus, Ohio, United States

Site Status

Midwest Retina

Dublin, Ohio, United States

Site Status

Retina Vitreous Center

Edmond, Oklahoma, United States

Site Status

Retina Northwest

Portland, Oregon, United States

Site Status

Mid Atlantic Retina - Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Site Status

Mid-Atlantic Retina

Philadelphia, Pennsylvania, United States

Site Status

Retina Consultants Of Carolina

Greenville, South Carolina, United States

Site Status

Charleston Neuroscience Inst

Ladson, South Carolina, United States

Site Status

Palmetto Retina Center

West Columbia, South Carolina, United States

Site Status

Southeastern Retina Associates Chattanooga

Chattanooga, Tennessee, United States

Site Status

Charles Retina Institute

Germantown, Tennessee, United States

Site Status

Tennessee Retina PC

Nashville, Tennessee, United States

Site Status

Retina Res Institute of Texas

Abilene, Texas, United States

Site Status

Austin Retina Associates

Austin, Texas, United States

Site Status

Austin Clinical Research LLC

Austin, Texas, United States

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Retina & Vitreous of Texas

Bellaire, Texas, United States

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Texas Retina Associates

Dallas, Texas, United States

Site Status

Valley Retina Institute P.A.

Harlingen, Texas, United States

Site Status

Medical Center Ophthalmology Associates

San Antonio, Texas, United States

Site Status

Retina Center of Texas

Southlake, Texas, United States

Site Status

Retina Consultants of Texas

The Woodlands, Texas, United States

Site Status

Eye Care Assoc of East Texas

Tyler, Texas, United States

Site Status

Strategic Clinical Research Group, LLC

Willow Park, Texas, United States

Site Status

Retina Associates of Utah, PLLC

Salt Lake City, Utah, United States

Site Status

University of Utah; Division of Gastroenterology/Hepatology

Salt Lake City, Utah, United States

Site Status

Uni of Vermont Medical Center;

Burlington, Vermont, United States

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Univ of Virginia Ophthalmology

Charlottesville, Virginia, United States

Site Status

Emerson Clinical Research Institute

Falls Church, Virginia, United States

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Piedmont Eye Center

Lynchburg, Virginia, United States

Site Status

Wagner Kapoor Institute

Norfolk, Virginia, United States

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Retina Institute of Virginia

Richmond, Virginia, United States

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West Virginia University Eye Institute

Morgantown, West Virginia, United States

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University of Wisconsin

Madison, Wisconsin, United States

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Fundacion Zambrano

CABA, , Argentina

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Oftalmos

Capital Federal, , Argentina

Site Status

Oftar

Mendoza, , Argentina

Site Status

Centro Oftalmólogos Especialistas

Rosario, , Argentina

Site Status

Grupo Laser Vision

Rosario, , Argentina

Site Status

Organizacion Medica de Investigacion

San Nicolás, , Argentina

Site Status

Strathfield Retina Clinic

Strathfield, New South Wales, Australia

Site Status

Sydney Eye Hospital

Sydney, New South Wales, Australia

Site Status

Sydney Retina Clinic and Day Surgery

Sydney, New South Wales, Australia

Site Status

Sydney West Retina

Westmead, New South Wales, Australia

Site Status

Centre For Eye Research Australia

East Melbourne, Victoria, Australia

Site Status

Retina Specialists Victoria

Rowville, Victoria, Australia

Site Status

The Lions Eye Institute

Nedlands, Western Australia, Australia

Site Status

LKH-Univ.Klinikum Graz; Universitäts-Augenklinik

Graz, , Austria

Site Status

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

Linz, , Austria

Site Status

Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

Vienna, , Austria

Site Status

Hanusch Krankenhaus; Abteilung für Augenkrankheiten mit Augen-Tagesklinik

Vienna, , Austria

Site Status

Hospital de Olhos de Aparecida - HOA

Aparecida de Goiânia, Goiás, Brazil

Site Status

Centro Brasileiro de Cirurgia

Goiânia, Goiás, Brazil

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Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, Brazil

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Botelho Hospital da Visao

Blumenau, Santa Catarina, Brazil

Site Status

Faculdade de Medicina do ABC - FMABC

Santo André, São Paulo, Brazil

Site Status

Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia

São Paulo, São Paulo, Brazil

Site Status

CEMAPE - Centro Médico

São Paulo, São Paulo, Brazil

Site Status

Hospital das Clinicas - FMUSP

São Paulo, São Paulo, Brazil

Site Status

Hosp de Olhos de Sorocaba

Sorocaba, São Paulo, Brazil

Site Status

Medical Center for Eye Health ? Focus Ltd

Sofia, , Bulgaria

Site Status

Pentagram Eye Hospital (Medical Center "Pentagram")

Sofia, , Bulgaria

Site Status

Spec. Ophth. Hospital for Active Treatment- Academic Pashev

Sofia, , Bulgaria

Site Status

Specialized Hospital for Active Treatment of Eye Diseases Zora

Sofia, , Bulgaria

Site Status

Calgary Retina Consultants

Calgary, Alberta, Canada

Site Status

QEII - HSC Department of Ophthalmology

Halifax, Nova Scotia, Canada

Site Status

Ivey Eye Institute

London, Ontario, Canada

Site Status

Toronto Retina Institute

Toronto, Ontario, Canada

Site Status

St. Michael's Hospital; Department of Ophthalmology

Toronto, Ontario, Canada

Site Status

University Health Network Toronto Western Hospital

Toronto, Ontario, Canada

Site Status

Institut De L'Oeil Des Laurentides

Boisbriand, Quebec, Canada

Site Status

FN Hradec Králové, O?ní klinika; Ophthalmology clinic

Hradec Králové, , Czechia

Site Status

Faculty Hospital Ostrava; Ophthalmology clinic

Ostrava, , Czechia

Site Status

Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic

Prague, , Czechia

Site Status

AXON Clinical

Prague, , Czechia

Site Status

Nemocnice Sokolov

Sokolov, , Czechia

Site Status

Aalborg Universitetshospital; Øjenafdelingen

Aalborg, , Denmark

Site Status

Sjællands Universitetshospital, Roskilde; Øjenafdelingen

Roskilde, , Denmark

Site Status

Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin

Bordeaux, , France

Site Status

Chi De Creteil; Ophtalmologie

Créteil, , France

Site Status

Pole Vision Val d'Ouest; Ophtalmologie

Écully, , France

Site Status

CHU Nantes - Hôtel Dieu; Ophthalmology

Nantes, , France

Site Status

Hopital Lariboisiere; Ophtalmologie

Paris, , France

Site Status

Centres Ophtalmologique St Exupéry; Ophtalmologie

Saint-Cyr-sur-Loire, , France

Site Status

Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde

Dresden, , Germany

Site Status

Universitätsklinikum Freiburg, Klinik für Augenheilkunde

Freiburg im Breisgau, , Germany

Site Status

Medizinische Hochschule Hannover, Klinik für Augenheilkunde

Hanover, , Germany

Site Status

Universitätsklinikum des Saarlandes; Klinik für Augenheilkunde

Homburg/Saar, , Germany

Site Status

Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik

Magdeburg, , Germany

Site Status

LMU Klinikum der Universität, Augenklinik

München, , Germany

Site Status

Klinikum rechts der Isar der TU München; Augenklinik

München, , Germany

Site Status

Augenabteilung am St. Franziskus-Hospital

Münster, , Germany

Site Status

Universitätsklinikum Münster; Augenheilkunde

Münster, , Germany

Site Status

Universitätsklinikum Würzburg, Augenklinik und Poliklinik

Würzburg, , Germany

Site Status

Queen Mary Hospital; Department of Ophthalmology

Hong Kong, , Hong Kong

Site Status

Hong Kong Eye Hospital; CUHK Eye Centre

Mong Kok, , Hong Kong

Site Status

Eszak-Pesti Centrumkorhaz - Honvedkorhaz; Szemeszet

Budapest, , Hungary

Site Status

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

Budapest, , Hungary

Site Status

Semmelweis Egyetem Szemészeti Vizsgálóhely

Budapest, , Hungary

Site Status

Bajcsy-Zsilinszky Hospital

Budapest, , Hungary

Site Status

Budapest Retina Associates Kft.

Budapest, , Hungary

Site Status

Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

Debrecen, , Hungary

Site Status

Ganglion Medial Center

Pécs, , Hungary

Site Status

Szegedi Tudományegyetem ÁOK; Department of Ophtalmology

Szeged, , Hungary

Site Status

Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET; Intezeti Gyogyszertar

Szombathely, , Hungary

Site Status

Zala Megyei Kórház; SZEMESZET

Zalaegerszeg, , Hungary

Site Status

Rambam Medical Center; Opthalmology

Haifa, , Israel

Site Status

Hadassah MC; Ophtalmology

Jerusalem, , Israel

Site Status

Rabin MC; Ophtalmology

Petah Tikva, , Israel

Site Status

Kaplan Medical Center; Ophtalmology

Rehovot, , Israel

Site Status

Tel Aviv Sourasky MC; Ophtalmology

Tel Aviv, , Israel

Site Status

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

Rome, Lazio, Italy

Site Status

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

Genoa, Liguria, Italy

Site Status

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

Milan, Lombardy, Italy

Site Status

Irccs Ospedale San Raffaele;U.O. Oculistica

Milan, Lombardy, Italy

Site Status

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

Florence, Tuscany, Italy

Site Status

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

Pisa, Tuscany, Italy

Site Status

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

Perugia, Umbria, Italy

Site Status

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

Negrar Di Valpolicella (VR), Veneto, Italy

Site Status

Sugita Eye Hospital

Aichi, , Japan

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Nagoya University Hospital

Aichi, , Japan

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Nagoya City University Hospital

Aichi, , Japan

Site Status

Aichi Medical University Hospital

Aichi, , Japan

Site Status

Toho University Sakura Medical Center

Chiba, , Japan

Site Status

Hayashi Eye Hospital

Fukuoka, , Japan

Site Status

Kurume University Hospital

Fukuoka, , Japan

Site Status

Hokkaido University Hospital

Hokkaido, , Japan

Site Status

Asahikawa Medical University Hospital

Hokkaido, , Japan

Site Status

Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)

Hyōgo, , Japan

Site Status

Kozawa eye hospital and diabetes center

Ibaraki, , Japan

Site Status

Ideta Eye Hospital

Kumamoto, , Japan

Site Status

Kyoto University Hospital

Kyoto, , Japan

Site Status

Mie University Hospital

Mie, , Japan

Site Status

University of Miyazaki Hospital

Miyazaki, , Japan

Site Status

Nara Medical University Hospital

Nara, , Japan

Site Status

Kitano Hospital

Osaka, , Japan

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Osaka Metropolitan University Hospital

Osaka, , Japan

Site Status

National Defense Medical College Hospital

Saitama, , Japan

Site Status

Shiga University Of Medical Science Hospital

Shiga, , Japan

Site Status

Tokyo Women's Medical University

Tokyo, , Japan

Site Status

Kyorin University Hospital

Tokyo, , Japan

Site Status

Tokyo Medical University Hachioji Medical Center

Tokyo, , Japan

Site Status

Centro Oftalmológico Mira, S.C

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

Site Status

Macula Retina Consultores

Mexico City, Mexico CITY (federal District), Mexico

Site Status

Hospital de la Ceguera APEC

Mexico City, Mexico CITY (federal District), Mexico

Site Status

Instituto de la retina del Bajio

Querétaro City, Querétaro, Mexico

Site Status

Mácula D&T

Lima, , Peru

Site Status

TG Laser Oftalmica

Lima, , Peru

Site Status

Oftalmolaser

Lima, , Peru

Site Status

Szpital sw. Lukasza

Bielsko-Biala, , Poland

Site Status

Specjalistyczny O?rodek Okulistyczny Oculomedica

Bydgoszcz, , Poland

Site Status

OFTALMIKA Sp. z o.o

Bydgoszcz, , Poland

Site Status

Szpital Specjalistyczny nr 1; Oddzial Okulistyki

Bytom, , Poland

Site Status

Dobry Wzrok Sp Z O O

Gda?sk, , Poland

Site Status

Optimum Profesorskie Centrum Okulistyki

Gda?sk, , Poland

Site Status

Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT

Gliwice, , Poland

Site Status

Gabinet Okulistyczny Prof Edward Wylegala

Katowice, , Poland

Site Status

Centrum Medyczne UNO-MED

Krakow, , Poland

Site Status

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

Krakow, , Poland

Site Status

Optomed Sp. z o.o.

Rybnik, , Poland

Site Status

Osrodek Chirurgii Oka prof. Zagorskiego Rzeszow

Rzeszów, , Poland

Site Status

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

Rzeszów, , Poland

Site Status

Caminomed

Tarnowskie Góry, , Poland

Site Status

Centrum Zdrowia MDM

Warsaw, , Poland

Site Status

SPEKTRUM Osrodek Okulistyki Klinicznej

Wroclaw, , Poland

Site Status

Hospital de Braga; Servico de Oftalmologia

Braga, , Portugal

Site Status

AIBILI - Association for Innovation and Biomedical Research on Light

Coimbra, , Portugal

Site Status

Espaco Medico Coimbra

Coimbra, , Portugal

Site Status

Hospital de Santa Maria; Servico de Oftalmologia

Lisbon, , Portugal

Site Status

Clinic Optimed

Ufa, Bashkortostan Republic, Russia

Site Status

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

Cheboksary, Mariy-El Republic, Russia

Site Status

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

Moscow, Moscow Oblast, Russia

Site Status

Medical Military Academy n.a S.M.Kirov

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

Clinics of Eye Diseases, LLC

Kazan', Tatarstan Republic, Russia

Site Status

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

Irkutsk, , Russia

Site Status

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

Novosibirsk, , Russia

Site Status

National University Hospital; Ophthalmology Department

Singapore, , Singapore

Site Status

Singapore Eye Research Institute

Singapore, , Singapore

Site Status

Tan Tock Seng Hospital; Ophthalmology Department

Singapore, , Singapore

Site Status

Nemocnica s poliklinikou Trebišov, a.s.

Trebišov, , Slovakia

Site Status

Fakultna nemocnica Trencin Ocna klinika

Trenčín, , Slovakia

Site Status

Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie

Žilina, , Slovakia

Site Status

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Site Status

Kyung Hee University Hospital

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Hospital General de Catalunya

San Cugat Del Valles, Barcelona, Spain

Site Status

Instituto Oftalmologico Gomez Ulla; Servicio de Oftalmologia

Santiago de Compostela, LA Coruña, Spain

Site Status

Hospital Universitario de Gran Canaria; Servicio de oftalmologia

Las Palmas de Gran Canaria, LAS Palmas, Spain

Site Status

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Site Status

Clinica Universitaria de Navarra; Servicio de Oftalmologia

Pamplona, Navarre, Spain

Site Status

Complejo Hospitalario de Navarra; Servicio de oftalmologia

Pamplona, Navarre, Spain

Site Status

Instituto Oftalmologico Fernandez Vega; Servicio de oftalmologia

Oviedo, Principality of Asturias, Spain

Site Status

Oftalvist Valencia

Burjassot, Valencia, Spain

Site Status

Complejo Hospitalario Universitario Albacete; Servicio de oftalmologia

Albacete, , Spain

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VISSUM Instituto Oftalmológico de Alicante

Alicante, , Spain

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Centro de Oftalmologia Barraquer; Servicio Oftalmologia

Barcelona, , Spain

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Hospital dos de maig; servicio de oftalmologia

Barcelona, , Spain

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Hospital Clinic de Barcelona; Consultas Externas Oftalmologia

Barcelona, , Spain

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Hospital de Santa Creu I Sant Pau; Servicio de Oftalmologia

Barcelona, , Spain

Site Status

Clinica Baviera; Servicio Oftalmologia

Madrid, , Spain

Site Status

Fisabio-Ofalmologia Medica; Servicio de Oftalmología

Valencia, , Spain

Site Status

Hospital Universitario Rio Hortega; Servicio de Oftalmologia

Valladolid, , Spain

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Vista Klinik Ophthalmologische Klinik

Binningen, , Switzerland

Site Status

Taipei Veterans General Hospital; Ophthalmology

Taipei, , Taiwan

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Chang Gung Medical Foundation - Linkou; Ophthalmology

Taoyuan District, , Taiwan

Site Status

National Taiwan University Hospital; Ophthalmology

Zhongzheng Dist., , Taiwan

Site Status

King Chulalongkorn Memorial Hospital; Ophthalmology Department

Bangkok, , Thailand

Site Status

Rajavithi Hospital; Ophthalmology Department

Bangkok, , Thailand

Site Status

Maharaj Nakorn ChiangMai Hospital; Ophthalmology Department

Chiang Mai, , Thailand

Site Status

Hacettepe University Medical Faculty; Department of Ophthalmology

Ankara, , Turkey (Türkiye)

Site Status

Ankara University Medical Faculty; Department of Ophthalmology

Ankara, , Turkey (Türkiye)

Site Status

Ankara Baskent University Medical Faculty; Department of Ophthalmology

Ankara, , Turkey (Türkiye)

Site Status

Beyoglu Goz Training and Research Hospital; Department Of Ophthalmology

Istanbul, , Turkey (Türkiye)

Site Status

Ege University Medical Faculty; Department of Ophthalmology

Izmir, , Turkey (Türkiye)

Site Status

Kocaeli Üniversitesi T?p Fakültesi; Department of Ophthalmology

Kocaeli, , Turkey (Türkiye)

Site Status

Selcuk University Faculty of Medicine; Department Of Ophthalmology

Konya, , Turkey (Türkiye)

Site Status

Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL

Belfast, , United Kingdom

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Bradford Royal Infirmary

Bradford, , United Kingdom

Site Status

East Kent Hospitals University NHS Foundation Trust

Canterbury, , United Kingdom

Site Status

Frimley Park Hospital

Frimley, , United Kingdom

Site Status

Gloucestershire Hospitals NHS Foundation Trust

Gloucestershire, , United Kingdom

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St James University Hospital

Leeds, , United Kingdom

Site Status

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

Liverpool, , United Kingdom

Site Status

Moorfields Eye Hospital NHS Foundation Trust

London, , United Kingdom

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Royal Free Hospital

London, , United Kingdom

Site Status

Kings College Hospital

London, , United Kingdom

Site Status

Manchester Royal Eye Hospital

Manchester, , United Kingdom

Site Status

Hillingdon Hospital

Middx, , United Kingdom

Site Status

Royal Victoria Infirmary

Newcastle upon Tyne, , United Kingdom

Site Status

James Paget University Hospitals NHS Foundation Trust

Norfolk, , United Kingdom

Site Status

University Hospital Southampton NHS Foundation Trust; Southampton Eye Unit

Southampton, , United Kingdom

Site Status

Sunderland Eye Infirmary

Sunderland, , United Kingdom

Site Status

Countries

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

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2020-000402-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GR41987

Identifier Type: -

Identifier Source: org_study_id

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