Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04432831
Other study ID # GR41987
Secondary ID 2020-000402-29
Status Completed
Phase Phase 3
First received
Last updated
Start date August 5, 2020
Est. completion date October 11, 2023

Study information

Verified date February 2024
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 GR40398 (NCT03622593), also referred to as the parent studies.


Recruitment information / eligibility

Status Completed
Enrollment 1479
Est. completion date October 11, 2023
Est. primary completion date October 11, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Argentina Fundacion Zambrano Caba
Argentina Oftalmos Capital Federal
Argentina Oftar Mendoza
Argentina Centro Oftalmólogos Especialistas Rosario
Argentina Grupo Laser Vision Rosario
Argentina Organizacion Medica de Investigacion San Nicolás
Australia Centre For Eye Research Australia East Melbourne Victoria
Australia The Lions Eye Institute Nedlands Western Australia
Australia Retina Specialists Victoria Rowville Victoria
Australia Strathfield Retina Clinic Strathfield 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
Austria LKH-Univ.Klinikum Graz; Universitäts-Augenklinik Graz
Austria Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde Linz
Austria Hanusch Krankenhaus; Abteilung für Augenkrankheiten mit Augen-Tagesklinik Wien
Austria Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie Wien
Brazil Hospital de Olhos de Aparecida - HOA Aparecida de Goiania GO
Brazil Botelho Hospital da Visao Blumenau SC
Brazil Centro Brasileiro de Cirurgia Goiania GO
Brazil Hospital das Clinicas - UFRGS Porto Alegre RS
Brazil Faculdade de Medicina do ABC - FMABC Santo Andre SP
Brazil CEMAPE - Centro Médico Sao Paulo SP
Brazil Hospital das Clinicas - FMUSP Sao Paulo SP
Brazil Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia Sao Paulo SP
Brazil Hosp de Olhos de Sorocaba Sorocaba SP
Bulgaria Medical Center for Eye Health ? Focus Ltd Sofia
Bulgaria Pentagram Eye Hospital (Medical Center "Pentagram") Sofia
Bulgaria Spec. Ophth. Hospital for Active Treatment- Academic Pashev Sofia
Bulgaria Specialized Hospital for Active Treatment of Eye Diseases Zora Sofia
Canada Institut De L'Oeil Des Laurentides Boisbriand Quebec
Canada Calgary Retina Consultants Calgary Alberta
Canada QEII - HSC Department of Ophthalmology Halifax Nova Scotia
Canada Ivey Eye Institute London Ontario
Canada St. Michael's Hospital; Department of Ophthalmology Toronto Ontario
Canada Toronto Retina Institute Toronto Ontario
Canada University Health Network Toronto Western Hospital Toronto Ontario
Czechia FN Hradec Králové, O?ní klinika; Ophthalmology clinic Hradec Králové
Czechia Faculty Hospital Ostrava; Ophthalmology clinic Ostrava
Czechia AXON Clinical Prague
Czechia Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic Prague
Czechia Nemocnice Sokolov Sokolov
Denmark Aalborg Universitetshospital; Øjenafdelingen Aalborg
Denmark Sjællands Universitetshospital, Roskilde; Øjenafdelingen Roskilde
France Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin Bordeaux
France Chi De Creteil; Ophtalmologie Creteil
France Pole Vision Val d'Ouest; Ophtalmologie Ecully
France CHU Nantes - Hôtel Dieu; Ophthalmology Nantes
France Hopital Lariboisiere; Ophtalmologie Paris
France Centres Ophtalmologique St Exupéry; Ophtalmologie St Cyr Sur Loire
Germany Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde Dresden
Germany Universitätsklinikum Freiburg, Klinik für Augenheilkunde Freiburg
Germany Medizinische Hochschule Hannover, Klinik für Augenheilkunde Hannover
Germany Universitätsklinikum des Saarlandes; Klinik für Augenheilkunde Homburg/Saar
Germany Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik Magdeburg
Germany Klinikum rechts der Isar der TU München; Augenklinik München
Germany LMU Klinikum der Universität, Augenklinik München
Germany Augenabteilung am St. Franziskus-Hospital Münster
Germany Universitätsklinikum Münster; Augenheilkunde Münster
Germany Universitätsklinikum Würzburg, Augenklinik und Poliklinik Würzburg
Hong Kong Queen Mary Hospital; Department of Ophthalmology Hong Kong
Hong Kong Hong Kong Eye Hospital; CUHK Eye Centre Mongkok
Hungary Bajcsy-Zsilinszky Hospital Budapest
Hungary Budapest Retina Associates Kft. Budapest
Hungary Eszak-Pesti Centrumkorhaz - Honvedkorhaz; Szemeszet Budapest
Hungary Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR Budapest
Hungary Semmelweis Egyetem Szemészeti Vizsgálóhely Budapest
Hungary Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika Debrecen
Hungary Ganglion Medial Center Pécs
Hungary Szegedi Tudományegyetem ÁOK; Department of Ophtalmology Szeged
Hungary Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET; Intezeti Gyogyszertar Szombathely
Hungary Zala Megyei Kórház; SZEMESZET Zalaegerszeg
Israel Rambam Medical Center; Opthalmology Haifa
Israel Hadassah MC; Ophtalmology Jerusalem
Israel Rabin MC; Ophtalmology Petach Tikva
Israel Kaplan Medical Center; Ophtalmology Rehovot
Israel Tel Aviv Sourasky MC; Ophtalmology Tel Aviv
Italy Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica Firenze Toscana
Italy UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA Genova Liguria
Italy Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica Milano Lombardia
Italy Irccs Ospedale San Raffaele;U.O. Oculistica Milano Lombardia
Italy Ospedale Classificato Equiparato Sacro Cuore ? Don Calabria; Dipartimento Oculistica Negrar - Verona Veneto
Italy Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia; Clinica Oculistica Perugia Umbria
Italy Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria Pisa Toscana
Italy Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico Roma Lazio
Japan Aichi Medical University Hospital Aichi
Japan Nagoya City University Hospital Aichi
Japan Nagoya University Hospital Aichi
Japan Sugita Eye Hospital Aichi
Japan Toho University Sakura Medical Center Chiba
Japan Hayashi Eye Hospital Fukuoka
Japan Kurume University Hospital Fukuoka
Japan Asahikawa Medical University Hospital Hokkaido
Japan Hokkaido University Hospital Hokkaido
Japan Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC) Hyogo
Japan Kozawa eye hospital and diabetes center Ibaraki
Japan Ideta Eye Hospital Kumamoto
Japan Kyoto University Hospital Kyoto
Japan Mie University Hospital Mie
Japan University of Miyazaki Hospital Miyazaki
Japan Nara Medical University Hospital Nara
Japan Kitano Hospital Osaka
Japan Osaka Metropolitan University Hospital Osaka
Japan National Defense Medical College Hospital Saitama
Japan Shiga University Of Medical Science Hospital Shiga
Japan Kyorin University Hospital Tokyo
Japan Tokyo Medical University Hachioji Medical Center Tokyo
Japan Tokyo Women's Medical University Tokyo
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Kyung Hee University Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Mexico Centro Oftalmológico Mira, S.C Del. Cuauhtemoc Mexico CITY (federal District)
Mexico Hospital de la Ceguera APEC Mexico, D.F. Mexico CITY (federal District)
Mexico Macula Retina Consultores Mexico, D.F. Mexico CITY (federal District)
Mexico Instituto de la retina del Bajio Querétaro Queretaro
Peru Mácula D&T Lima
Peru Oftalmolaser Lima
Peru TG Laser Oftalmica Lima
Poland Szpital sw. Lukasza Bielsko-Biala
Poland OFTALMIKA Sp. z o.o Bydgoszcz
Poland Specjalistyczny O?rodek Okulistyczny Oculomedica Bydgoszcz
Poland Szpital Specjalistyczny nr 1; Oddzial Okulistyki Bytom
Poland Dobry Wzrok Sp Z O O Gda?sk
Poland Optimum Profesorskie Centrum Okulistyki Gda?sk
Poland Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT Gliwice
Poland Gabinet Okulistyczny Prof Edward Wylegala Katowice
Poland Centrum Medyczne UNO-MED Krakow
Poland SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej Krakow
Poland Optomed Sp. z o.o. Rybnik
Poland Kliniczny Szpital Wojewodzki nr 1 im. F. Chopina; Klinika Okulistyki Rzeszów
Poland Osrodek Chirurgii Oka prof. Zagorskiego Rzeszow Rzeszów
Poland Caminomed Tarnowskie Góry
Poland Centrum Zdrowia MDM Warszawa
Poland SPEKTRUM Osrodek Okulistyki Klinicznej Wroclaw
Portugal Hospital de Braga; Servico de Oftalmologia Braga
Portugal AIBILI - Association for Innovation and Biomedical Research on Light Coimbra
Portugal Espaco Medico Coimbra Coimbra
Portugal Hospital de Santa Maria; Servico de Oftalmologia Lisboa
Russian Federation Intersec Research and Technology Complex ?Eye Microsurgery? n.a. S.N. Fyodorov; Cheboksary Branch Cheboksary Marij EL
Russian Federation ?Intersec. Research and Technology Complex ?Eye Microsurgery? n a Fyodorov Irkutsk branch Irkutsk
Russian Federation Clinics of Eye Diseases, LLC Kazan Tatarstan
Russian Federation FSBI ?Scientific Research Institute of Eye Diseases? of Russian Academy of medical Sciences Moscow Moskovskaja Oblast
Russian Federation ?Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch Novosibirsk
Russian Federation Medical Military Academy n.a S.M.Kirov St.Petersburg Sankt Petersburg
Russian Federation Clinic Optimed UFA Baskortostan
Singapore National University Hospital; Ophthalmology Department Singapore
Singapore Singapore Eye Research Institute Singapore
Singapore Tan Tock Seng Hospital; Ophthalmology Department Singapore
Slovakia Nemocnica s poliklinikou Trebišov, a.s. Trebišov
Slovakia Fakultna nemocnica Trencin Ocna klinika Trencin
Slovakia Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie Zilina
Spain Complejo Hospitalario Universitario Albacete; Servicio de oftalmologia Albacete
Spain VISSUM Instituto Oftalmológico de Alicante Alicante
Spain Centro de Oftalmologia Barraquer; Servicio Oftalmologia Barcelona
Spain Hospital Clinic de Barcelona; Consultas Externas Oftalmologia Barcelona
Spain Hospital de Santa Creu I Sant Pau; Servicio de Oftalmologia Barcelona
Spain Hospital dos de maig; servicio de oftalmologia Barcelona
Spain Oftalvist Valencia Burjassot Valencia
Spain Hospital Universitario de Bellvitge Hospitalet de Llobregat Barcelona
Spain Hospital Universitario de Gran Canaria; Servicio de oftalmologia Las Palmas de Gran Canaria LAS Palmas
Spain Clinica Baviera; Servicio Oftalmologia Madrid
Spain Hospital Universitario Puerta de Hierro Majadahonda Madrid
Spain Instituto Oftalmologico Fernandez Vega; Servicio de oftalmologia Oviedo Asturias
Spain Clinica Universitaria de Navarra; Servicio de Oftalmologia Pamplona Navarra
Spain Complejo Hospitalario de Navarra; Servicio de oftalmologia Pamplona Navarra
Spain Hospital General de Catalunya San Cugat Del Valles Barcelona
Spain Instituto Oftalmologico Gomez Ulla; Servicio de Oftalmologia Santiago de Compostela LA Coruña
Spain Fisabio-Ofalmologia Medica; Servicio de Oftalmología Valencia
Spain Hospital Universitario Rio Hortega; Servicio de Oftalmologia Valladolid
Switzerland Vista Klinik Ophthalmologische Klinik Binningen
Taiwan Taipei Veterans General Hospital; Ophthalmology Taipei
Taiwan Chang Gung Medical Foundation - Linkou; Ophthalmology Taoyuan
Taiwan National Taiwan University Hospital; Ophthalmology Zhongzheng Dist.
Thailand King Chulalongkorn Memorial Hospital; Ophthalmology Department Bangkok
Thailand Rajavithi Hospital; Ophthalmology Department Bangkok
Thailand Maharaj Nakorn ChiangMai Hospital; Ophthalmology Department ChiangMai
Turkey Ankara Baskent University Medical Faculty; Department of Ophthalmology Ankara
Turkey Ankara University Medical Faculty; Department of Ophthalmology Ankara
Turkey Hacettepe University Medical Faculty; Department of Ophthalmology Ankara
Turkey Beyoglu Goz Training and Research Hospital; Department Of Ophthalmology Istanbul
Turkey Ege University Medical Faculty; Department of Ophthalmology Izmir
Turkey Kocaeli Üniversitesi T?p Fakültesi; Department of Ophthalmology Kocaeli
Turkey Selcuk University Faculty of Medicine; Department Of Ophthalmology Konya
United Kingdom Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL Belfast
United Kingdom Bradford Royal Infirmary Bradford
United Kingdom East Kent Hospitals University NHS Foundation Trust Canterbury
United Kingdom Frimley Park Hospital Frimley
United Kingdom Gloucestershire Hospitals NHS Foundation Trust Gloucestershire
United Kingdom St James University Hospital Leeds
United Kingdom Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre Liverpool
United Kingdom Kings College Hospital London
United Kingdom Moorfields Eye Hospital NHS Foundation Trust London
United Kingdom Royal Free Hospital London
United Kingdom Manchester Royal Eye Hospital Manchester
United Kingdom Hillingdon Hospital Middx
United Kingdom Royal Victoria Infirmary Newcastle upon Tyne
United Kingdom James Paget University Hospitals NHS Foundation Trust Norfolk
United Kingdom University Hospital Southampton NHS Foundation Trust; Southampton Eye Unit Southampton
United Kingdom Sunderland Eye Infirmary Sunderland
United States Retina Consultants of Hawaii 'Aiea Hawaii
United States Retina Res Institute of Texas Abilene Texas
United States Capital Region Retina Albany New York
United States University of New Mexico Albuquerque New Mexico
United States Western Carolina Retinal Associate PA Asheville North Carolina
United States Southeast Retina Center Augusta Georgia
United States University of Colorado; dept of ophthalmology Aurora Colorado
United States Austin Clinical Research LLC Austin Texas
United States Austin Retina Associates Austin Texas
United States California Retina Consultants Bakersfield California
United States Johns Hopkins Med; Wilmer Eye Inst Baltimore Maryland
United States The Retina Care Center Baltimore Maryland
United States Retina & Vitreous of Texas Bellaire Texas
United States Retina-Vitreous Associates Medical Group Beverly Hills California
United States Beetham Eye Institute, Joslin Diabetes Center Boston Massachusetts
United States Ophthalmic Consultants of Boston Boston Massachusetts
United States Tufts Medical Center; Ophthalmology Boston Massachusetts
United States Uni of Vermont Medical Center; Burlington Vermont
United States Retinal Diagnostic Center Campbell California
United States Char Eye Ear &Throat Assoc Charlotte North Carolina
United States Univ of Virginia Ophthalmology Charlottesville Virginia
United States Southeastern Retina Associates Chattanooga Chattanooga Tennessee
United States Midwest Vision Research Foundation Chesterfield Missouri
United States Retina Group of Washington Chevy Chase Maryland
United States Cincinnati Eye Institute Cincinnati Ohio
United States Cleveland Clinic Foundation; Cole Eye Institute Cleveland Ohio
United States Retina Assoc of Cleveland Inc Cleveland Ohio
United States Retina Consultants of Southern Colorado Springs Colorado
United States The Ohio State University Havener Eye Institute Columbus Ohio
United States Texas Retina Associates Dallas Texas
United States Rand Eye Deerfield Beach Florida
United States Midwest Retina Dublin Ohio
United States VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota Edina Minnesota
United States NJRetina Edison New Jersey
United States Retina Vitreous Center Edmond Oklahoma
United States The Retina Partners Encino California
United States Emerson Clinical Research Institute Falls Church Virginia
United States Retina Group of Florida Fort Lauderdale Florida
United States National Ophthalmic Research Institute Fort Myers Florida
United States Eye Medical Center Fresno California
United States Retina Consultants of Orange County Fullerton California
United States Charles Retina Institute Germantown Tennessee
United States Associated Retinal Consultants Grand Rapids Michigan
United States Foundation for Vision Research Grand Rapids Michigan
United States Vitreo-Retinal Associates Grand Rapids Michigan
United States Retina Consultants Of Carolina Greenville South Carolina
United States Cumberland Valley Retina PC Hagerstown Maryland
United States Valley Retina Institute P.A. Harlingen Texas
United States Long Is. Vitreoretinal Consult Hauppauge New York
United States Graystone Eye Hickory North Carolina
United States Midwest Eye Institute Indianapolis Indiana
United States Charleston Neuroscience Inst Ladson South Carolina
United States Colorado Retina Associates, PC Lakewood Colorado
United States Retina Associates Lenexa Kansas
United States Retina Associates of Kentucky Lexington Kentucky
United States Retina Vit Surgeons/Central NY Liverpool New York
United States Southern California Permanente Medical Group Los Angeles California
United States Piedmont Eye Center Lynchburg Virginia
United States University of Wisconsin Madison Wisconsin
United States Georgia Retina PC Marietta Georgia
United States Florida Eye Associates Melbourne Florida
United States Barnet Dulaney Perkins Eye Center Mesa Arizona
United States West Virginia University Eye Institute Morgantown West Virginia
United States Northern California Retina Vitreous Associates Mountain View California
United States Tennessee Retina PC Nashville Tennessee
United States New York University New York New York
United States Wagner Kapoor Institute Norfolk Virginia
United States Retinal & Ophthalmic Cons PC Northfield New Jersey
United States University Retina and Macula Associates, PC Oak Forest Illinois
United States East Bay Retina Consultants Oakland California
United States Ophthalmic Cons of Long Island Oceanside New York
United States Retina Care Specialists Palm Beach Gardens Florida
United States Southern CA Desert Retina Cons Palm Desert California
United States California Eye Specialists Medical group Inc. Pasadena California
United States Retina Specialty Institute Pensacola Florida
United States Mid Atlantic Retina - Wills Eye Hospital Philadelphia Pennsylvania
United States Mid-Atlantic Retina Philadelphia Pennsylvania
United States Arizona Retina and Vitreous Consultants Phoenix Arizona
United States Retinal Research Institute, LLC Phoenix Arizona
United States Fort Lauderdale Eye Institute Plantation Florida
United States Maine Eye Center Portland Maine
United States Retina Northwest Portland Oregon
United States Retina Consultants, San Diego Poway California
United States Retina Consultants of Southern California Redlands California
United States Sierra Eye Associates Reno Nevada
United States Retina Institute of Virginia Richmond Virginia
United States Retina Associates of Western New York Rochester New York
United States Assoc Retinal Consultants PC Royal Oak Michigan
United States Retinal Consultants Med Group Sacramento California
United States Retina Vitreous Assoc of FL Saint Petersburg Florida
United States Retina Associates of Utah, PLLC Salt Lake City Utah
United States University of Utah; Division of Gastroenterology/Hepatology Salt Lake City Utah
United States Medical Center Ophthalmology Associates San Antonio Texas
United States West Coast Retina Medical Group San Francisco California
United States Orange County Retina Med Group Santa Ana California
United States California Retina Consultants Santa Barbara California
United States California Retina Consultants - Santa Maria Santa Maria California
United States Island Retina Shirley New York
United States The Retina Consultants Slingerlands New York
United States Retina Center of Texas Southlake Texas
United States Prairie Eye & LASIK Center / Prairie Retina Center Springfield Illinois
United States Southern Vitreoretinal Assoc Tallahassee Florida
United States Retina Associates of Florida, LLC Tampa Florida
United States Retina Associates of NJ Teaneck New Jersey
United States Retina Consultants of Texas The Woodlands Texas
United States Retina Specialists Towson Maryland
United States Associated Retinal Consultants, P.C. Traverse City Michigan
United States Retina Associates Southwest PC Tucson Arizona
United States Eye Care Assoc of East Texas Tyler Texas
United States Bay Area Retina Associates Walnut Creek California
United States Retina Group of New England Waterford Connecticut
United States Palmetto Retina Center West Columbia South Carolina
United States Wolfe Eye Clinic West Des Moines Iowa
United States Vitreo-Retinal Consultants Wichita Kansas
United States Strategic Clinical Research Group, LLC Willow Park Texas
United States Wake Forest Baptist Health Eye Centre Winston-Salem North Carolina
United States Vitreo-Retinal Associates, PC Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Brazil,  Bulgaria,  Canada,  Czechia,  Denmark,  France,  Germany,  Hong Kong,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Peru,  Poland,  Portugal,  Russian Federation,  Singapore,  Slovakia,  Spain,  Switzerland,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence and Severity of Ocular Adverse Events Up to 2 years
Primary Incidence and Severity of Systemic (Non-Ocular) Adverse Events Up to 2 years
Primary Number of Participants with Presence of Anti-Drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study From Baseline up to 2 years
See also
  Status Clinical Trial Phase
Completed NCT03953807 - A Study to Evaluate the Effectiveness and Safety of OZURDEX® in Patients With Diabetic Macular Edema But Never Treated Phase 4
Completed NCT03622580 - A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE) Phase 3
Recruiting NCT06262737 - Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol
Terminated NCT04603937 - A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) Phase 3
Terminated NCT04611152 - A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) Phase 3
Active, not recruiting NCT04108156 - This Study Will Evaluate the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Participants With Diabetic Macular Edema Compared With Intravitreal Ranibizumab Phase 3
Completed NCT02867735 - A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema Phase 1
Withdrawn NCT03629210 - Combination OZURDEX® & EyLea® vs. OZURDEX® Monotherapy in IncompLete-Responders wIth Diabetic Macular Edema Phase 2
Withdrawn NCT02842541 - Safety Study of Intravitreal EBI-031 Given as a Single or Repeat Injection to Subjects With Diabetic Macular Edema Phase 1
Completed NCT02221453 - Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide Phase 2
Completed NCT02556723 - Intravitreal Injections of Ziv-aflibercept for Macular Diseases N/A
Completed NCT02979665 - Changes to the Retina Following Anti-VEGF Treatments for Diabetic Macular Edema
Completed NCT02000102 - Outcomes of Diabetic Macula Edema Patients Switched to Aflibercept From Bevacizumab and/or Ranibizumab N/A
Completed NCT02088229 - Relating Retinal Structural and Functional Parameters to Visual Acuity in Eyes Undergoing Treatment for Diabetic Macular Edema N/A
Terminated NCT00779142 - Utility of Intravitreal Methotrexate in Diabetic Macular Edema Resistant to Conventional Therapies N/A
Completed NCT01171976 - Efficacy and Safety of Ranibizumab in Two "Treat and Extend" Treatment Algorithms Versus Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus Phase 3
Completed NCT00989989 - Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema Phase 3
Completed NCT01259609 - Changes in Ciliary Body Thickness in Patients With Diabetic Macular Edema After Vitrectomy N/A
Terminated NCT00768040 - Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema Phase 2
Completed NCT00683176 - Effect of Choline Fenofibrate (SLV348) on Macular Edema Phase 2