A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion (COMINO)

July 10, 2024 updated by: Hoffmann-La Roche

A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion

This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in patients with macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

729

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Caba, Argentina, C1017AAO
    - Fundacion Zambrano
  - Capital Federal, Argentina, C1015ABO
    - Centro Oftalmologico Dr. Charles S.A.
  - Capital Federal, Argentina, C1120AAN
    - Oftalmos
  - Capital Federal, Argentina, C1199ABC
    - Hospital Italiano; Ophtalmology
  - Ciudad Autonoma Buenos Aires, Argentina, C1061AAE
    - Buenos Aires Mácula
  - Mendoza, Argentina, M5500GGK
    - Oftar
  - Rosario, Argentina, S2000DLA
    - Grupo Laser Vision
  - Rosario, Argentina, S2000ANJ
    - Centro Oftalmólogos Especialistas
  - San Nicolás, Argentina, C1015ABO
    - Organizacion Medica de Investigacion
Australia
- New South Wales
  - Albury, New South Wales, Australia, 2640
    - Eyeclinic Albury Wodonga
  - Strathfield, New South Wales, Australia, 2135
    - Strathfield Retina Clinic
  - Sydney, New South Wales, Australia, 2000
    - Save Sight Institute
  - Sydney, New South Wales, Australia, 2000
    - Sydney Retina Clinic and Day Surgery
- Victoria
  - East Melbourne, Victoria, Australia, 3002
    - Centre for Eye Research Australia
  - Rowville, Victoria, Australia, 3178
    - Retina Specialists Victoria
- Western Australia
  - Nedlands, Western Australia, Australia, 6009
    - The Lions Eye Institute
Austria
- - Graz, Austria, 8036
    - LKH-Univ.Klinikum Graz; Universitäts-Augenklinik
  - Wien, Austria, 1090
    - Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie
Brazil
- GO
  - Aparecida de Goiania, GO, Brazil, 74980-010
    - Hospital de Olhos de Aparecida - HOA
- RS
  - Porto Alegre, RS, Brazil, 90035-903
    - Hospital das Clinicas - UFRGS
- SC
  - Blumenau, SC, Brazil, 89052-504
    - Botelho Hospital da Visao
- SP
  - Sao Paulo, SP, Brazil, 04023-062
    - Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia
  - Sorocaba, SP, Brazil, 18031-060
    - Hosp de Olhos de Sorocaba
China
- - Beijing, China, 100730
    - Beijing Hospital of Ministry of Health
  - Changchun, China, 130041
    - The Second Hospital of Jilin University
  - Chengdu, China, 610041
    - West China Hospital, Sichuan University
  - Guangzhou City, China, 510060
    - Zhongshan Ophthalmic Center, Sun Yat-sen University
  - Hangzhou City, China, 310009
    - The Second Affiliated Hospital of Zhejiang University School of Medicine
  - Harbin, China, 150001
    - The 2nd Affiliated Hospital of Harbin Medical University
  - Shanghai, China, 200080
    - Shanghai First People's Hospital
  - Shanghai, China, 200072
    - Shanghai Tenth People's Hospital
  - Shenyang City, China, 110034
    - He Eye Specialist Shenyang Hospital
  - Shenzhen City, China, 518053
    - The University of Hong Kong-Shenzhen Hospital; Local Ethic Committee
  - Tianjin City, China, 300050
    - Tianjin Eye Hospital
  - Tianjin City, China, 300070
    - Tianjin Medical University Eye Hospital
  - Wenzhou City, China, 325027
    - Eye Hospital, Wenzhou Medical University
  - Wuhan, China, 430060
    - Renmin Hospital of Wuhan University
  - Zhengzhou, China
    - Henan Provincial Eye Hosptial
Czechia
- - Prague, Czechia
    - AXON Clinical
  - Prague, Czechia, 128 08
    - General Teaching Hospital Prague; Ophthalmology clinic
France
- - Creteil, France, 94010
    - Chi De Creteil; Ophtalmologie
  - Paris, France, 75010
    - Hopital Lariboisiere; Ophtalmologie
  - Paris, France, 75015
    - Centre Ophtalmologique; Imagerie et laser
  - St Cyr Sur Loire, France, 37540
    - Centres Ophtalmologique St Exupéry; Ophtalmologie
Germany
- - Düsseldorf-Oberkassel, Germany, 40549
    - Internationale Innovative Ophthalmochirurgie GbR; c/o Makula-Netzhaut-Zentrum Breyer Kaymak Klabe
  - Freiburg, Germany, 79106
    - Universitätsklinikum Freiburg, Klinik für Augenheilkunde
  - Ludwigshafen, Germany, 67063
    - Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik
Hong Kong
- - Hong Kong, Hong Kong
    - Queen Mary Hospital; Department of Ophthalmology
  - Mongkok, Hong Kong
    - Hong Kong Eye Hospital; CUHK Eye Centre
Hungary
- - Budapest, Hungary, 1133
    - Budapest Retina Associates Kft.
  - Budapest, Hungary, 1106
    - Bajcsy-Zsilinszky Hospital
  - Debrecen, Hungary, 4032
    - Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
  - Szeged, Hungary, 6720
    - Szegedi Tudományegyetem ÁOK; Department of Ophtalmology
  - Zalaegerszeg, Hungary, 8900
    - Zala Megyei Kórház; SZEMESZET
Israel
- - Haifa, Israel, 3109601
    - Rambam Medical Center; Opthalmology
  - Jerusalem, Israel, 9112001
    - Hadassah MC; Ophtalmology
  - Petach Tikva, Israel, 4941492
    - Rabin MC; Ophtalmology
  - Rehovot, Israel, 7660101
    - Kaplan Medical Center; Ophtalmology
  - Tel Aviv, Israel, 6423906
    - Tel Aviv Sourasky MC; Ophtalmology
Italy
- Lazio
  - Roma, Lazio, Italy, 00198
    - Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
- Lombardia
  - Milano, Lombardia, Italy, 20132
    - Irccs Ospedale San Raffaele;U.O. Oculistica
Japan
- - Aichi, Japan, 480-1195
    - Aichi Medical University Hospital
  - Aichi, Japan, 460-0008
    - Sugita Eye Hospital
  - Aichi, Japan, 466-8560
    - Nagoya University Hospital
  - Aichi, Japan, 467-8602
    - Nagoya City University Hospital
  - Chiba, Japan, 285-8741
    - Toho University Sakura Medical Center
  - Fukuoka, Japan, 830-0011
    - Kurume University Hospital
  - Fukuoka, Japan, 812-0011
    - Hayashi Eye Hospital
  - Hokkaido, Japan, 078-8510
    - Asahikawa Medical University Hospital
  - Hyogo, Japan, 663-8501
    - Hyogo Medical University Hospital
  - Hyogo, Japan, 660-8550
    - Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)
  - Ibaraki, Japan, 310-0845
    - Kozawa Eye Hospital And Diabetes Center
  - Kagawa, Japan, 761-0793
    - Kagawa University Hospital
  - Kagoshima, Japan, 890-8520
    - Kagoshima University Hospital
  - Mie, Japan, 514-8507
    - Mie University Hospital
  - Miyagi, Japan, 960-1295
    - Fukushima Medical University Hospital
  - Nagano, Japan, 390-8621
    - Shinshu University Hospital
  - Osaka, Japan, 545-8586
    - Osaka Metropolitan university Hospital
  - Osaka, Japan, 570-8507
    - Kansai Medical University Medical Center
  - Tokyo, Japan, 162-8666
    - Tokyo Women's Medical University Hospital
  - Tokyo, Japan, 193-0998
    - Tokyo Medical University Hachioji Medical Center
Korea, Republic of
- - Busan, Korea, Republic of, 602-739
    - Pusan National University Hospital
  - Daegu, Korea, Republic of, 42415
    - Yeungnam University Medical Center
  - Seongnam-si, Korea, Republic of, 463-707
    - Seoul National University Bundang Hospital
  - Seoul, Korea, Republic of, 03080
    - Seoul National University Hospital
  - Seoul, Korea, Republic of, 05505
    - Asan Medical Center
  - Seoul, Korea, Republic of, 02447
    - Kyung Hee University Hospital
  - Seoul, Korea, Republic of, 06351
    - Samsung Medical Center
  - Seoul, Korea, Republic of, 07301
    - Kim's Eye Hospital
Poland
- - Bielsko-Biala, Poland, 43-309
    - Szpital sw. Lukasza
  - Bydgoszcz, Poland, 85-631
    - OFTALMIKA Sp. z o.o
  - Bydgoszcz, Poland, 85-870
    - Specjalistyczny O?rodek Okulistyczny Oculomedica
  - Bytom, Poland, 41-902
    - Szpital Specjalistyczny nr 1; Oddzial Okulistyki
  - Gda?sk, Poland, 80-402
    - Dobry Wzrok Sp Z O O
  - Gda?sk, Poland, 80-809
    - Optimum Profesorskie Centrum Okulistyki
  - Gliwice, Poland, 44-100
    - Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT
  - Katowice, Poland, 40-594
    - Gabinet Okulistyczny Prof Edward Wylegala
  - Krakow, Poland, 31-501
    - SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej
  - Kraków, Poland, 31-070
    - Centrum Medyczne Dietla 19 Sp. z o.o.
  - Krosno, Poland, 38-400
    - MT Medic Krosno
  - Na??czów, Poland, 24-140
    - O?rodek Chirurgii Oka Prof. Zagórskiego Na??czów
  - Piaseczno, Poland, 05-500
    - Centrum Medyczne Pulawska Sp. z o.o.
  - Rybnik, Poland, 44-203
    - Lens Clinic
  - Tarnowskie Góry, Poland, 42-600
    - Caminomed
  - Warszawa, Poland, 00-189
    - Centrum Zdrowia MDM
  - Wroclaw, Poland, 53-334
    - SPEKTRUM Osrodek Okulistyki Klinicznej
Portugal
- - Coimbra, Portugal, 3000-075
    - Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia
  - Coimbra, Portugal, 3030-163
    - Espaco Medico Coimbra
  - Lisboa, Portugal, 1649-035
    - Hospital de Santa Maria; Servico de Oftalmologia
Russian Federation
- Baskortostan
  - UFA, Baskortostan, Russian Federation, 450059
    - Clinic Optimed
- Marij EL
  - Cheboksary, Marij EL, Russian Federation, 428000
    - Intersec Research and Technology Complex ?Eye Microsurgery? n.a. S.N. Fyodorov; Cheboksary Branch
- Moskovskaja Oblast
  - Moscow, Moskovskaja Oblast, Russian Federation, 119435
    - FSBI ?Scientific Research Institute of Eye Diseases? of Russian Academy of medical Sciences
- Sankt Petersburg
  - Sankt-peterburg, Sankt Petersburg, Russian Federation, 197022
    - 1 Saint-Petersburg St. Med. University named after academician I.P.Pavlov; Chair of ophathalmology
  - St.Petersburg, Sankt Petersburg, Russian Federation, 124044
    - Medical Military Academy n.a S.M.Kirov
Singapore
- - Singapore, Singapore, 168751
    - Singapore Eye Research Institute
  - Singapore, Singapore, 308433
    - Tan Tock Seng Hospital; Ophthalmology Department
Spain
- - Barcelona, Spain, 08021
    - Centro de Oftalmologia Barraquer; Servicio Oftalmologia
  - Barcelona, Spain, 08028
    - Hospital Clinic de Barcelona; Consultas Externas Oftalmologia
  - Barcelona, Spain, 08041
    - Hospital de Santa Creu I Sant Pau; Servicio de Oftalmologia
  - Valladolid, Spain, 47012
    - Hospital Universitario Rio Hortega; Servicio de Oftalmologia
- Barcelona
  - Hospitalet de Llobregat, Barcelona, Spain, 08907
    - Hospital Universitario de Bellvitge
  - San Cugat Del Valles, Barcelona, Spain, 08195
    - Hospital General De Catalunya
- Madrid
  - Majadahonda, Madrid, Spain, 28222
    - Hospital Universitario Puerta de Hierro
- Navarra
  - Pamplona, Navarra, Spain, 31008
    - Complejo Hospitalario de Navarra; Servicio de oftalmologia
Taiwan
- - Changhua, Taiwan, 500
    - Changhua Christian Hospital; Department of Ophthalmology
  - Taipei, Taiwan, 11217
    - Taipei Veterans General Hospital; Ophthalmology
  - Taoyuan, Taiwan, 333
    - Chang Gung Medical Foundation - Linkou; Ophthalmology
United Kingdom
- - Belfast, United Kingdom, BT12 6BA
    - Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL
  - Birmingham, United Kingdom, B18 7QH
    - Birmingham Midland Eye Centre
  - Bradford, United Kingdom, BD9 6RJ
    - Opthalmology Research Office
  - Bristol, United Kingdom, BS1 2LX
    - Bristol Eye Hospital;Retinal Treatment and Research Unit
  - Cardiff, United Kingdom, CF14 4XW
    - University Hospital of wales
  - Leeds, United Kingdom, LS9 7TF
    - St James University Hospital
  - Liverpool, United Kingdom, L7 8YE
    - Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre
  - London, United Kingdom, NW10 7NS
    - Central Middlesex Hospital
  - Maidstone, United Kingdom, ME16 9QQ
    - Maidstone and Tunbridge Wells NHS Trust
  - Newcastle upon Tyne, United Kingdom, NE1 4LP
    - Royal Victoria Infirmary
United States
- Arizona
  - Mesa, Arizona, United States, 85206
    - Barnet Dulaney Perkins Eye Center
  - Phoenix, Arizona, United States, 85014
    - Retinal Research Institute, LLC
  - Tucson, Arizona, United States, 85704
    - Retina Associates Southwest PC
- California
  - Campbell, California, United States, 95008
    - Retinal Diagnostic Center
  - Encino, California, United States, 91436
    - The Retina Partners
  - Fullerton, California, United States, 92835-3424
    - Retina Consultants of Orange County
  - Mountain View, California, United States, 94040
    - Northern California Retina Vitreous Associates
  - Oakland, California, United States, 94609
    - East Bay Retina Consultants
  - Pasadena, California, United States, 91107
    - California Eye Specialists Medical Group Inc.
  - Poway, California, United States, 92064
    - Retina Consultants, San Diego
  - San Francisco, California, United States, 94109
    - West Coast Retina Medical Group
- Colorado
  - Colorado Springs, Colorado, United States, 80909
    - Retina Consultants of Southern Colorado PC
  - Lakewood, Colorado, United States, 80228
    - Colorado Retina Associates, PC
- Connecticut
  - Waterford, Connecticut, United States, 06385
    - Retina Group of New England
- Florida
  - Deerfield Beach, Florida, United States, 33064
    - Rand Eye
  - Deerfield Beach, Florida, United States, 33064
    - Advanced Research
  - Melbourne, Florida, United States, 32901
    - Florida Eye Associates
  - Plantation, Florida, United States, 33324
    - Fort Lauderdale Eye Institute
  - Saint Petersburg, Florida, United States, 33711
    - Retina Vitreous Assoc of FL
  - Tampa, Florida, United States, 33609
    - Retina Associates of Florida, LLC
- Georgia
  - Augusta, Georgia, United States, 30909
    - Southeast Retina Center
  - Marietta, Georgia, United States, 30060-1137
    - Georgia Retina PC
- Hawaii
  - 'Aiea, Hawaii, United States, 96701
    - Retina Consultants Of Hawaii
- Illinois
  - Chicago, Illinois, United States, 60611
    - Northwestern Medical Group/Northwestern University
  - Elmhurst, Illinois, United States, 60126
    - Retina Associated Ltd
  - Oak Forest, Illinois, United States, 60452
    - University Retina and Macula Associates, PC
  - Springfield, Illinois, United States, 62704
    - Prairie Retina Center
- Kansas
  - Lenexa, Kansas, United States, 66215
    - Retina Associates
- Maryland
  - Baltimore, Maryland, United States, 21287
    - Johns Hopkins Med; Wilmer Eye Inst
  - Chevy Chase, Maryland, United States, 20815
    - Retina Group of Washington
  - Hagerstown, Maryland, United States, 21740
    - Cumberland Valley Retina PC
- Michigan
  - Royal Oak, Michigan, United States, 48073
    - Assoc Retinal Consultants PC
- Minnesota
  - Edina, Minnesota, United States, 55435
    - VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota
- Missouri
  - Chesterfield, Missouri, United States, 63017
    - Midwest Vision Research Foundation
- Nevada
  - Reno, Nevada, United States, 89502
    - Sierra Eye Associates
- New York
  - Hauppauge, New York, United States, 11788
    - Long Is. Vitreoretinal Consult
  - Liverpool, New York, United States, 13088
    - Retina Vit Surgeons/Central NY
  - Rochester, New York, United States, 14620
    - Retina Assoc of Western NY
- Ohio
  - Cincinnati, Ohio, United States, 45242
    - Cincinnati Eye Institute
- Oregon
  - Portland, Oregon, United States, 97221
    - Retina Northwest
  - Springfield, Oregon, United States, 97477
    - Cascade Medical Research Institute LLC
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19107
    - Mid Atlantic Retina - Wills Eye Hospital
- South Carolina
  - Ladson, South Carolina, United States, 29456
    - Charleston Neuroscience Institute
  - West Columbia, South Carolina, United States, 29169
    - Palmetto Retina Center
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Black Hills Eye Institute
- Tennessee
  - Germantown, Tennessee, United States, 38138
    - Charles Retina Institute
  - Nashville, Tennessee, United States, 37203
    - Tennessee Retina PC
- Texas
  - Abilene, Texas, United States, 79606
    - Retina Res Institute of Texas
  - Austin, Texas, United States, 78750
    - Austin Clinical Research LLC
  - Austin, Texas, United States, 78705-1169
    - Austin Retina Associates
  - Bellaire, Texas, United States, 77401-3510
    - Retina & Vitreous of Texas
  - Dallas, Texas, United States, 75231
    - Texas Retina Associates
  - The Woodlands, Texas, United States, 77384-4167
    - Retina Consultants of Texas
  - Willow Park, Texas, United States, 76087
    - Strategic Clinical Research Group, LLC
- Utah
  - Salt Lake City, Utah, United States, 84107
    - Retina Associates of Utah, PLLC
- Virginia
  - Lynchburg, Virginia, United States, 24502
    - Piedmont Eye Center
- West Virginia
  - Morgantown, West Virginia, United States, 26506
    - West Virginia University Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Foveal center-involved macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO), diagnosed no longer than 4 months prior to the screening visit
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:

Any major illness or major surgical procedure within 1 month before screening
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

Ocular Exclusion Criteria for Study Eye:

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)

Ocular Exclusion Criteria for Both Eyes:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: Faricimab Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm. Other Names: RO6867461 RG7716 VABYSMO® faricimab-svoa Procedure: 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.
Active Comparator: 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).	Drug: Faricimab Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm. Other Names: RO6867461 RG7716 VABYSMO® faricimab-svoa Drug: 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). Other Names: Eylea Procedure: 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.

Participant Group / Arm

Intervention / Treatment

Experimental: 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).

Drug: Faricimab

Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm.

Other Names:

RO6867461
RG7716
VABYSMO®
faricimab-svoa

Procedure: 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.

Active Comparator: 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).

Drug: Faricimab

Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm.

Other Names:

RO6867461
RG7716
VABYSMO®
faricimab-svoa

Drug: 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).

Other Names:

Eylea

Procedure: Sham Procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 24 Time Frame: From Baseline through Week 24	Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors [baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.	From Baseline through Week 24

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Collaborators

Chugai Pharmaceutical

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2021

Primary Completion (Actual)

August 9, 2022

Study Completion (Actual)

July 12, 2023

Study Registration Dates

First Submitted

February 3, 2021

First Submitted That Met QC Criteria

February 3, 2021

First Posted (Actual)

February 5, 2021

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

July 10, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

CRVO
HRVO

Additional Relevant MeSH Terms

Other Study ID Numbers

GR41986
2020-000441-13 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Central Retinal Vein Occlusion

Clinical Trials on Faricimab

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Medical Conditions

Drug Interventions

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Conditions

Rare Diseases

Drug Interventions

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Sponsor/Collaborators

Locations