A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion
NCT ID: NCT04740931
Last Updated: 2024-08-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
729 participants
INTERVENTIONAL
2021-03-02
2023-07-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).
Faricimab
Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm.
Sham Procedure
The sham is a procedure that mimics an IVT injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).
Faricimab
Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm.
Aflibercept
Aflibercept 2 mg will be administered by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
Sham Procedure
The sham is a procedure that mimics an IVT injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
Interventions
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Faricimab
Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm.
Aflibercept
Aflibercept 2 mg will be administered by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
Sham Procedure
The sham is a procedure that mimics an IVT injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Best-corrected visual acuity (BCVA) of 73 to 19 letters, inclusive (20/40 to 20/400 approximate Snellen equivalent)
* Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis
* For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs during the treatment period and for 3 months after the final dose of study treatment
Exclusion Criteria
* Uncontrolled blood pressure
* Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1
* Pregnant or breastfeeding, or intending to become pregnant during the study
* History of previous episodes of macular edema due to RVO or persistent macular edema due to RVO diagnosed more than 4 months before screening
* Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than macular edema due to RVO in the study eye (e.g., ischemic maculopathy, Irvine-Gass syndrome, foveal atrophy, foveal fibrosis, pigment abnormalities, dense subfoveal hard exudates, or other non-retinal conditions)
* Macular laser (focal/grid) in the study eye at any time prior to Day 1
* Panretinal photocoagulation in the study eye within 3 months prior to Day 1 or anticipated within 3 months of study start on Day 1
* Any prior or current treatment for macular edema; macular neovascularization, including diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD); and vitreomacular-interface abnormalities, including, but not restricted to, IVT treatment with anti-VEGF, steroids, tissue plasminogen activator, ocriplasmin, C3F8, air or periocular injection
* Any prior intervention with verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or vitreo-retinal surgery including sheathotomy
* Any prior steroid implant use including dexamethasone intravitreal implant (Ozurdex) and fluocinolone acetonide intravitreal implant (Iluvien)
* Prior IVT administration of faricimab in either eye
* History of idiopathic or autoimmune-associated uveitis in either eye
* Active periocular, ocular or intraocular inflammation or infection (including suspected) in either eye on Day 1
18 Years
ALL
No
Sponsors
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Chugai Pharmaceutical
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Bristol Eye Hospital;Retinal Treatment and Research Unit
Bristol, , United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
St James University Hospital
Leeds, , United Kingdom
Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre
Liverpool, , United Kingdom
Central Middlesex Hospital
London, , United Kingdom
Maidstone and Tunbridge Wells NHS Trust
Maidstone, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
Barnet Dulaney Perkins Eye Center
Mesa, Arizona, United States
Retinal Research Institute, LLC
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
Retina Consultants of Orange County
Fullerton, California, United States
Northern California Retina Vitreous Associates
Mountain View, California, United States
East Bay Retina Consultants
Oakland, California, United States
California Eye Specialists Medical group Inc.
Pasadena, California, United States
Retina Consultants, San Diego
Poway, California, United States
West Coast Retina Medical Group
San Francisco, California, United States
Retina Consultants of Southern Colorado PC
Colorado Springs, Colorado, United States
Colorado Retina Associates, PC
Lakewood, Colorado, United States
Retina Group of New England
Waterford, Connecticut, United States
Advanced Research
Deerfield Beach, Florida, United States
Rand Eye
Deerfield Beach, Florida, United States
Florida Eye Associates
Melbourne, Florida, United States
Fort Lauderdale Eye Institute
Plantation, Florida, United States
Retina Vitreous Assoc of FL
St. Petersburg, 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
Retina Associated Ltd
Elmhurst, Illinois, United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, United States
Prairie Retina Center
Springfield, Illinois, United States
Retina Associates
Lenexa, Kansas, United States
Johns Hopkins Med; Wilmer Eye Inst
Baltimore, Maryland, United States
Retina Group of Washington
Chevy Chase, Maryland, United States
Cumberland Valley Retina PC
Hagerstown, Maryland, United States
Assoc Retinal Consultants PC
Royal Oak, Michigan, United States
VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota
Edina, Minnesota, United States
Midwest Vision Research Foundation
Chesterfield, Missouri, United States
Sierra Eye Associates
Reno, Nevada, United States
Long Is. Vitreoretinal Consult
Hauppauge, New York, United States
Retina Vit Surgeons/Central NY
Liverpool, New York, United States
Retina Assoc of Western NY
Rochester, New York, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Retina Northwest
Portland, Oregon, United States
Cascade Medical Research Institute LLC
Springfield, Oregon, United States
Mid Atlantic Retina - Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Charleston Neuroscience Institute
Ladson, South Carolina, United States
Palmetto Retina Center
West Columbia, South Carolina, United States
Black Hills Eye Institute
Rapid City, South Dakota, 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
Retina & Vitreous of Texas
Bellaire, Texas, United States
Texas Retina Associates
Dallas, Texas, United States
Retina Consultants of Texas
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
Piedmont Eye Center
Lynchburg, Virginia, United States
West Virginia University Eye Institute
Morgantown, West Virginia, United States
Fundacion Zambrano
CABA, , Argentina
Centro Oftalmológico Dr. Charles S.A.
Capital Federal, , Argentina
Oftalmos
Capital Federal, , Argentina
Hospital Italiano; Ophtalmology
Capital Federal, , Argentina
Buenos Aires Mácula
Ciudad Autonoma Buenos Aires, , Argentina
Oftar
Mendoza, , Argentina
Centro Oftalmólogos Especialistas
Rosario, , Argentina
Grupo Laser Vision
Rosario, , Argentina
Organizacion Medica de Investigacion
San Nicolás, , Argentina
Eyeclinic Albury Wodonga
Albury, New South Wales, Australia
Strathfield Retina Clinic
Strathfield, New South Wales, Australia
Save Sight Institute
Sydney, New South Wales, Australia
Sydney Retina Clinic and Day Surgery
Sydney, 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; Universitäts-Augenklinik
Graz, , Austria
Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie
Vienna, , Austria
Hospital de Olhos de Aparecida - HOA
Aparecida de Goiânia, Goiás, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, Brazil
Botelho Hospital da Visao
Blumenau, Santa Catarina, Brazil
Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia
São Paulo, São Paulo, Brazil
Hosp de Olhos de Sorocaba
Sorocaba, São Paulo, Brazil
Beijing Hospital of Ministry of Health
Beijing, , China
The Second Hospital of Jilin University
Changchun, , China
West China Hospital, Sichuan University
Chengdu, , China
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, , China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, , China
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, , China
Shanghai Tenth People's Hospital
Shanghai, , China
Shanghai First People's Hospital
Shanghai, , China
He Eye Specialist Shenyang Hospital
Shenyang, , China
The University of Hong Kong-Shenzhen Hospital; Local Ethic Committee
Shenzhen, , China
Tianjin Eye Hospital
Tianjin, , China
Tianjin Medical University Eye Hospital
Tianjin, , China
Eye Hospital, Wenzhou Medical University
Wenzhou, , China
Renmin Hospital of Wuhan University
Wuhan, , China
Henan Provincial Eye Hosptial
Zhengzhou, , China
General Teaching Hospital Prague; Ophthalmology clinic
Prague, , Czechia
AXON Clinical
Prague, , Czechia
Chi De Creteil; Ophtalmologie
Créteil, , France
Hopital Lariboisiere; Ophtalmologie
Paris, , France
Centre Ophtalmologique; Imagerie et laser
Paris, , France
Centres Ophtalmologique St Exupéry; Ophtalmologie
Saint-Cyr-sur-Loire, , France
Internationale Innovative Ophthalmochirurgie GbR; c/o Makula-Netzhaut-Zentrum Breyer Kaymak Klabe
Düsseldorf-Oberkassel, , Germany
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
Freiburg im Breisgau, , Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik
Ludwigshafen, , Germany
Queen Mary Hospital; Department of Ophthalmology
Hong Kong, , Hong Kong
Hong Kong Eye Hospital; CUHK Eye Centre
Mong Kok, , Hong Kong
Bajcsy-Zsilinszky Hospital
Budapest, , Hungary
Budapest Retina Associates Kft.
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
Debrecen, , Hungary
Szegedi Tudományegyetem ÁOK; Department of Ophtalmology
Szeged, , Hungary
Zala Megyei Kórház; SZEMESZET
Zalaegerszeg, , Hungary
Rambam Medical Center; Opthalmology
Haifa, , Israel
Hadassah MC; Ophtalmology
Jerusalem, , Israel
Rabin MC; Ophtalmology
Petah Tikva, , Israel
Kaplan Medical Center; Ophtalmology
Rehovot, , Israel
Tel Aviv Sourasky MC; Ophtalmology
Tel Aviv, , Israel
Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
Rome, Lazio, Italy
Irccs Ospedale San Raffaele;U.O. Oculistica
Milan, Lombardy, Italy
Sugita Eye Hospital
Aichi, , Japan
Nagoya University Hospital
Aichi, , Japan
Nagoya City University Hospital
Aichi, , Japan
Aichi Medical University 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
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
Mie University Hospital
Mie, , Japan
Fukushima Medical University Hospital
Miyagi, , Japan
Shinshu University Hospital
Nagano, , Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
Kansai Medical University Medical Center
Osaka, , Japan
Tokyo Women's Medical University Hospital
Tokyo, , Japan
Tokyo Medical University Hachioji Medical Center
Tokyo, , Japan
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 Dietla 19 Sp. Z O.O.
Krakow, , Poland
SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej
Krakow, , Poland
MT Medic Krosno
Krosno, , Poland
O?rodek Chirurgii Oka Prof. Zagórskiego Na??czów
Na??czów, , Poland
Centrum Medyczne Pulawska SP. z o.o.
Piaseczno, , Poland
Lens Clinic
Rybnik, , Poland
Caminomed
Tarnowskie Góry, , Poland
Centrum Zdrowia MDM
Warsaw, , Poland
SPEKTRUM Osrodek Okulistyki Klinicznej
Wroclaw, , Poland
Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia
Coimbra, , Portugal
Espaco Medico Coimbra
Coimbra, , Portugal
Hospital de Santa Maria; Servico de Oftalmologia
Lisbon, , Portugal
Clinic Optimed
Ufa, Bashkortostan Republic, Russia
Intersec Research and Technology Complex ?Eye Microsurgery? n.a. S.N. Fyodorov; Cheboksary Branch
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; Chair of ophathalmology
Saint Petersburg, Sankt-Peterburg, Russia
Singapore Eye Research Institute
Singapore, , Singapore
Tan Tock Seng Hospital; Ophthalmology Department
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
Kyung Hee University Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Kim's 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
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Complejo Hospitalario de Navarra; Servicio de oftalmologia
Pamplona, Navarre, 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 Universitario Rio Hortega; Servicio de Oftalmologia
Valladolid, , Spain
Changhua Christian Hospital; Department of Ophthalmology
Changhua, , Taiwan
Taipei Veterans General Hospital; Ophthalmology
Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou; Ophthalmology
Taoyuan District, , Taiwan
Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL
Belfast, , United Kingdom
Birmingham Midland Eye Centre
Birmingham, , United Kingdom
Opthalmology Research Office
Bradford, , United Kingdom
Countries
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References
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Danzig CJ, Dinah C, Ghanchi F, Hattenbach LO, Khanani AM, Lai TYY, Shimura M, Abreu F, Arrisi P, Liu Y, Paris LP, Retiere AC, Willis JR, Schlottmann PG; BALATON and COMINO Investigators. Faricimab Treat-and-Extend Dosing for Macular Edema Due to Retinal Vein Occlusion: 72-Week Results from the BALATON and COMINO Trials. Ophthalmol Retina. 2025 Sep;9(9):848-859. doi: 10.1016/j.oret.2025.03.005. Epub 2025 Mar 17.
Tadayoni R, Paris LP, Danzig CJ, Abreu F, Khanani AM, Brittain C, Lai TYY, Haskova Z, Sakamoto T, Kotecha A, Schlottmann PG, Liu Y, Seres A, Retiere AC, Willis JR, Yoon YH; BALATON and COMINO Investigators. Efficacy and Safety of Faricimab for Macular Edema due to Retinal Vein Occlusion: 24-Week Results from the BALATON and COMINO Trials. Ophthalmology. 2024 Aug;131(8):950-960. doi: 10.1016/j.ophtha.2024.01.029. Epub 2024 Jan 26.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-000441-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GR41986
Identifier Type: -
Identifier Source: org_study_id
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