A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (RHINE)

June 20, 2023 updated by: Hoffmann-La Roche

A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (RHINE)

This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).

Study Overview

Status

Completed

Conditions

Diabetic Macular Edema

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

951

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, C1120AAN
    - Oftalmos
  - 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
  - Strathfield, New South Wales, Australia, 2135
    - Strathfield Retina Clinic
  - Sydney, New South Wales, Australia, 2000
    - Sydney Eye Hospital
  - Sydney, New South Wales, Australia, 2000
    - Sydney Retina Clinic and Day Surgery
  - Westmead, New South Wales, Australia, 2145
    - Sydney West Retina
- 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
Brazil
- GO
  - Aparecida de Goiania, GO, Brazil, 74980-010
    - Hospital de Olhos de Aparecida - HOA
  - Goiania, GO, Brazil, 74210-010
    - Centro Brasileiro de Cirurgia
- RS
  - Porto Alegre, RS, Brazil, 90035-903
    - Hospital das Clinicas - UFRGS
- SC
  - Blumenau, SC, Brazil, 89052-504
    - Botelho Hospital da Visao
- SP
  - Santo Andre, SP, Brazil, 09060-650
    - Faculdade de Medicina do ABC - FMABC
  - Sao Paulo, SP, Brazil, 04023-062
    - Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia
  - Sao Paulo, SP, Brazil, 04084-002
    - CEMAPE - Centro Médico
  - Sao Paulo, SP, Brazil, 05403-900
    - Hospital das Clinicas - FMUSP
  - Sorocaba, SP, Brazil, 18031-060
    - Hosp de Olhos de Sorocaba
Canada
- Alberta
  - Calgary, Alberta, Canada, T2J 0C8
    - Calgary Retina Consultants
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 1M9
    - University of British Columbia - Vancouver Coastal Health Authority
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 2Y9
    - QEII - HSC Department of Ophthalmology
- Ontario
  - Etobicoke, Ontario, Canada, M8X 2X3
    - Vitreous Retina Macula Specialists of Toronto
  - London, Ontario, Canada, N6A 4V2
    - Ivey Eye Institute
  - Ottawa, Ontario, Canada, K1H 8L6
    - University of Ottawa Eye Institute
  - Toronto, Ontario, Canada, M3C 0G9
    - Toronto Retina Institute
  - Toronto, Ontario, Canada, M5B IW8
    - Unity Health Toronto
  - Toronto, Ontario, Canada, M5T 2S9
    - University Health Network Toronto Western Hospital
- Quebec
  - Boisbriand, Quebec, Canada, J7H 0E8
    - Institut De L'oeil Des Laurentides
  - Montreal, Quebec, Canada, H1T 2M4
    - Hôpital Maisonneuve - Rosemont
China
- - Beijing, China, 100050
    - Beijing Friendship Hospital
  - Beijing, China, 100730
    - Beijing Tongren Hospital
  - Beijing City, China, 100032
    - Peking Union Medical College Hospital
  - Changchun, China, 130041
    - The Second Hospital of Jilin University
  - Chengdu, China, 610041
    - West China Hospital, Sichuan University
  - Chongqing City, China, 400014
    - Southwest Hospital , Third Military Medical University; Ophthalmology
  - Chongqing City, China, 400042
    - Army Medical Center of PLA(Daping Hospital)
  - Guangzhou City, China, 510060
    - Zhongshan Ophthalmic Center, Sun Yat-sen University
  - Nanjing City, China, 210029
    - The Affiliated Eye Hospital of Nanjing Medical University
  - Shanghai, China, 200080
    - Shanghai First People's Hospital
  - Shanghai, China, 200072
    - Shanghai Tenth People's Hospital
  - 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
  - Wuxi, China, 214000
    - Wuxi No.2 People's Hospital
Czechia
- - Hradec Králové, Czechia, 500 05
    - FN Hradec Králové, O?ní klinika; Ophthalmology clinic
  - Ostrava, Czechia, 708 52
    - Faculty Hospital Ostrava; Ophthalmology clinic
  - Prague, Czechia, 100 34
    - Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic
  - Prague, Czechia
    - AXON Clinical
  - Sokolov, Czechia, 356 01
    - Nemocnice Sokolov
Denmark
- - Aalborg, Denmark, 9000
    - Aalborg Universitetshospital; Øjenafdelingen
  - Glostrup, Denmark, 2600
    - Rigshospitalet Glostrup; Afdeling for Øjensygdomme, Center for Forskning
  - Roskilde, Denmark, 4000
    - Sjællands Universitetshospital, Roskilde; Øjenafdelingen
France
- - Creteil, France, 94010
    - Chi De Creteil; Ophtalmologie
  - Dijon, France, 21079
    - CHU Bocage; Ophtalmologie
  - Lyon cedex, France, 69317
    - Hopital de la croix rousse; Ophtalmologie
  - Paris, France, 75015
    - Centre Ophtalmologique; Imagerie et laser
  - Paris, France, 75012
    - CHNO des Quinze Vingts; Ophtalmologie
  - St Cyr Sur Loire, France, 37540
    - Centres Ophtalmologique St Exupéry; Ophtalmologie
  - Toulouse, France, 31059
    - Hôpital PURPAN - CHU TOULOUSE; Ophtalmologie
Germany
- - Dresden, Germany, 01307
    - Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde
  - Freiburg, Germany, 79106
    - Universitätsklinikum Freiburg, Klinik für Augenheilkunde
  - Homburg/Saar, Germany, 66424
    - Universitätsklinikum des Saarlandes; Klinik für Augenheilkunde
  - Magdeburg, Germany, 39120
    - Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik
  - München, Germany, 80336
    - LMU Klinikum der Universität, Augenklinik
  - München, Germany, 81675
    - Klinikum rechts der Isar der TU München; Augenklinik
  - Würzburg, Germany, 97080
    - Universitätsklinikum Würzburg, Augenklinik und Poliklinik
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, 1068
    - Magyar Honvedseg Egeszsegugyi Kozpont; Szemészeti Osztály
  - Budapest, Hungary, 1076
    - Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR
  - Budapest, Hungary, 1085
    - Semmelweis Egyetem Szemészeti Vizsgálóhely
  - Budapest, Hungary, 1106
    - Bajcsy-Zsilinszky Hospital
Italy
- Lazio
  - Roma, Lazio, Italy, 00133
    - Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche
- Lombardia
  - Milano, Lombardia, Italy, 20157
    - ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)
- Toscana
  - Firenze, Toscana, Italy, 50134
    - Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica
  - Pisa, Toscana, Italy, 56124
    - Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria
- Veneto
  - Negrar - Verona, Veneto, Italy, 37024
    - Ospedale Classificato Equiparato Sacro Cuore ? Don Calabria; Dipartimento Oculistica
  - Udine, Veneto, Italy, 33100
    - A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica
Korea, Republic of
- - Seongnam-si, Korea, Republic of, 463-707
    - Seoul National University Bundang Hospital
  - Seoul, Korea, Republic of, 135-710
    - Samsung Medical Center
  - Seoul, Korea, Republic of, 03080
    - Seoul National University Hospital
  - Seoul, Korea, Republic of, 02447
    - Kyung Hee University Hospital
  - Seoul, Korea, Republic of, 5505
    - Asan Medical Center.
Poland
- - Bydgoszcz, Poland, 85-631
    - OFTALMIKA Sp. z o.o
  - Bydgoszcz, Poland, 85-870
    - Specjalistyczny O?rodek Okulistyczny Oculomedica
  - Gda?sk, Poland, 80-809
    - Optimum Profesorskie Centrum Okulistyki
  - Gliwice, Poland, 44-100
    - Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT
  - Krakow, Poland, 31-501
    - SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej
  - Rzeszów, Poland, 35-017
    - Osrodek Chirurgii Oka prof. Zagorskiego Rzeszow
  - Tarnowskie Góry, Poland, 42-600
    - Caminomed
  - Warszawa, Poland, 00-635
    - Centrum Zdrowia MDM
Portugal
- - Braga, Portugal, 4710-243
    - Hospital de Braga; Servico de Oftalmologia
  - Coimbra, Portugal, 3030-163
    - Espaco Medico Coimbra
  - Coimbra, Portugal, 3000-548
    - AIBILI - Association for Innovation and Biomedical Research on Light
  - Lisboa, Portugal, 1649-035
    - Hospital de Santa Maria; Servico de Oftalmologia
Russian Federation
- - Irkutsk, Russian Federation, 664033
    - ?Intersec. Research and Technology Complex ?Eye Microsurgery? n a Fyodorov Irkutsk branch
  - Novosibirsk, Russian Federation, 630096
    - ?Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch
- Marij EL
  - Cheboksary, Marij EL, Russian Federation, 428000
    - Intersec Research and Technology Complex ?Eye Microsurgery? n.a. S.N. Fyodorov; Cheboksary Branch
- Tatarstan
  - Kazan, Tatarstan, Russian Federation, 420066
    - Clinics of Eye Diseases, LLC
Singapore
- - Singapore, Singapore, 168751
    - Singapore Eye Research Institute
  - Singapore, Singapore, 308433
    - Tan Tock Seng Hospital; Ophthalmology Department
  - Singapore, Singapore, 119074
    - National University Hospital; Ophthalmology Department
Spain
- - Barcelona, Spain, 08022
    - Institut de la Macula i la retina
  - Barcelona, Spain, 08025
    - Hospital dos de maig; Pharmacy Service
  - Madrid, Spain, 28046
    - Clinica Baviera; Servicio Oftalmologia
  - Madrid, Spain, 28040
    - Hospital Clinico San Carlos; Servicio de oftalmologia
  - Valencia, Spain, 46015
    - Fisabio-Ofalmologia Medica; Servicio de Oftalmología
  - Valladolid, Spain, 47012
    - Hospital Universitario Rio Hortega; Servicio de Oftalmologia
- Asturias
  - Oviedo, Asturias, Spain, 33012
    - Instituto Oftalmologico Fernandez Vega; 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
- Navarra
  - Pamplona, Navarra, Spain, 31008
    - Complejo Hospitalario de Navarra; Servicio de oftalmologia
- Valencia
  - Burjassot, Valencia, Spain, 46100
    - Oftalvist Valencia
Switzerland
- - Binningen, Switzerland, 4102
    - Vista Klinik Ophthalmologische Klinik
Taiwan
- - Taipei, Taiwan, 11217
    - Taipei Veterans General Hospital; Ophthalmology
  - Taoyuan, Taiwan, 333
    - Chang Gung Medical Foundation - Linkou; Ophthalmology
  - Zhongzheng Dist., Taiwan, 10002
    - National Taiwan University Hospital; Ophthalmology
Thailand
- - Bangkok, Thailand, 10330
    - King Chulalongkorn Memorial Hospital; Ophthalmology Department
  - Bangkok, Thailand, 10400
    - Rajavithi Hospital; Ophthalmology Department
  - ChiangMai, Thailand, 50200
    - Maharaj Nakorn ChiangMai Hospital; Ophthalmology Department
Turkey
- - Ankara, Turkey, 06340
    - Ankara University Medical Faculty; Department of Ophthalmology
  - Ankara, Turkey, 06490
    - Ankara Baskent University Medical Faculty; Department of Ophthalmology
  - Istanbul, Turkey, 34421
    - Beyoglu Goz Training and Research Hospital; Department Of Ophthalmology
  - Kocaeli, Turkey, 41380
    - Kocaeli Üniversitesi T?p Fakültesi; Department of Ophthalmology
United Kingdom
- - Barnet, United Kingdom, EN5 3DJ
    - Barnet Hospital; ROYAL FREE LONDON NHS FOUNDATION TRUST
  - Belfast, United Kingdom, BT12 6BA
    - Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL
  - Bradford, United Kingdom, BD9 6RJ
    - Bradford Royal Infirmary
  - Bristol, United Kingdom, BS1 2LX
    - University Hospitals Bristol NHS Foundation Trust, Bristol Eye Hospital
  - Canterbury, United Kingdom, CT1 3NG
    - East Kent Hospitals University NHS Foundation Trust
  - Frimley, United Kingdom, GU16 7UJ
    - Frimley Park Hospital
  - Gloucestershire, United Kingdom, GL1 3NN
    - Gloucestershire Hospitals NHS Foundation Trust
  - 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, EC1V 2PD
    - Moorfields Eye Hospital NHS Foundation Trust
  - London, United Kingdom, NW3 2QS
    - Royal Free Hospital
  - London, United Kingdom, SW9 8RR
    - Kings College Hospital
  - Manchester, United Kingdom, M13 9WL
    - Manchester Royal Eye Hospital
  - Middx, United Kingdom, UB8 3NN
    - Hillingdon Hospital
  - Newcastle upon Tyne, United Kingdom, NE1 4LP
    - Royal Victoria Infirmary
  - Norfolk, United Kingdom, NR31 6LA
    - James Paget University Hospitals NHS Foundation Trust
  - Southampton, United Kingdom, SO16 6YD
    - University Hospital Southampton NHS Foundation Trust; Southampton Eye Unit
  - Sunderland, United Kingdom, SR2 9HP
    - Sunderland Eye Infirmary
United States
- Arizona
  - Phoenix, Arizona, United States, 85014
    - Retinal Research Institute, LLC
  - Phoenix, Arizona, United States, 85020
    - Associated Retina Consultants
- Arkansas
  - Springdale, Arkansas, United States, 72762
    - Northwest Arkansas Retina Associates
- California
  - Bakersfield, California, United States, 93309
    - California Retina Consultants
  - Beverly Hills, California, United States, 90211
    - Retina-Vitreous Associates Medical Group
  - 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
  - Sacramento, California, United States, 95825
    - Retinal Consultants Med Group
  - Santa Barbara, California, United States, 93103
    - California Retina Consultants
  - Walnut Creek, California, United States, 94598
    - Bay Area Retina Associates
- Colorado
  - Aurora, Colorado, United States, 80045
    - University of Colorado; dept of ophthalmology
  - Colorado Springs, Colorado, United States, 80909
    - Retina Consultants of Southern
- Connecticut
  - Waterford, Connecticut, United States, 06385
    - Retina Group of New England
- Florida
  - Fort Lauderdale, Florida, United States, 33308
    - Retina Group of Florida
  - Fort Myers, Florida, United States, 33912
    - National Ophthalmic Research Institute
  - Melbourne, Florida, United States, 32901
    - Florida Eye Associates
  - Palm Beach Gardens, Florida, United States, 33418
    - Bascom Palmer Eye Institute
  - Plantation, Florida, United States, 33324
    - Fort Lauderdale Eye Institute
  - Saint Petersburg, Florida, United States, 33711
    - Retina Vitreous Assoc of FL
- Georgia
  - Augusta, Georgia, United States, 30909
    - Southeast Retina Center
- Illinois
  - Oak Forest, Illinois, United States, 60452
    - University Retina and Macula Associates, PC
  - Springfield, Illinois, United States, 62704
    - Prairie Retina Center
- Maryland
  - Towson, Maryland, United States, 21204
    - Retina Specialists
- Massachusetts
  - Boston, Massachusetts, United States, 02111
    - Tufts Medical Center; Ophthalmology
- Michigan
  - Grand Rapids, Michigan, United States, 49546
    - Vitreo-Retinal Associates
  - Grand Rapids, Michigan, United States, 49546
    - Associated Retinal Consultants
- Nevada
  - Las Vegas, Nevada, United States, 89144
    - Retina Consultants of Nevada
- New Jersey
  - Bloomfield, New Jersey, United States, 07003
    - Envision Ocular, LLC
- New York
  - Hauppauge, New York, United States, 11788
    - Long Is. Vitreoretinal Consult
  - New York, New York, United States, 10017
    - New York University
  - Oceanside, New York, United States, 11572
    - Ophthalmic Cons of Long Island
  - Rochester, New York, United States, 14642
    - University of Rochester Flaum Eye Institute
  - Rochester, New York, United States, 14620
    - Retina Assoc of Western NY
  - Slingerlands, New York, United States, 12159
    - The Retina Consultants
- Ohio
  - Cleveland, Ohio, United States, 44195-0001
    - Cleveland Clinic Foundation; Cole Eye Institute
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19107
    - Mid Atlantic Retina - Wills Eye Hospital
- South Carolina
  - Greenville, South Carolina, United States, 29605
    - Retina Consultants of Carolina
  - Ladson, South Carolina, United States, 29456
    - Charleston Neuroscience Inst
  - West Columbia, South Carolina, United States, 29169
    - Palmetto Retina Center
- Tennessee
  - Chattanooga, Tennessee, United States, 37421
    - Southeastern Retina Associates Chattanooga
  - Knoxville, Tennessee, United States, 37923
    - Southeastern Retina Associates
  - Nashville, Tennessee, United States, 37203
    - Tennessee Retina PC
- Texas
  - Austin, Texas, United States, 78705-1169
    - Austin Retina Associates
  - Southlake, Texas, United States, 76092
    - Retina Center of Texas
  - The Woodlands, Texas, United States, 77384-4167
    - Retina Consultants of Texas
- Virginia
  - Charlottesville, Virginia, United States, 22903
    - Univ of Virginia Ophthalmology
  - Richmond, Virginia, United States, 23235
    - Retina Institute of Virginia
- Washington
  - Silverdale, Washington, United States, 98383
    - Retina Center Northwest

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:

Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
Hemoglobin A1c (HbA1c) of less than or equal to (≤)10% within 2 months prior to Day 1
Macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea
Decreased visual acuity attributable primarily to DME
Ability and willingness to undertake all scheduled visits and assessments
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:

Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to Day 1
Uncontrolled blood pressure, defined as a systolic value greater than (>)180 millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient is at rest
Currently pregnant or breastfeeding, or intend to become pregnant during the study
Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye
Any intraocular or periocular corticosteroid treatment within 6 months prior to Day 1 to the study eye
Prior administration of IVT faricimab in either eye
Active intraocular or periocular infection or active intraocular inflammation in the study eye
Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
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 DME in the study eye
Other protocol-specified inclusion/exclusion criteria may apply

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: A: Faricimab 6 mg Q8W Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.	Drug: Faricimab Faricimab 6 mg was administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or according to a personalized treatment interval (PTI) in arm B. Other Names: VABYSMO™ RO6867461 RG7716 Procedure: 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. It was administered to participants in all three treatments arms at applicable visits to maintain masking among treatment arms.
Experimental: B: Faricimab 6 mg PTI Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.	Drug: Faricimab Faricimab 6 mg was administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or according to a personalized treatment interval (PTI) in arm B. Other Names: VABYSMO™ RO6867461 RG7716 Procedure: 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. It was administered to participants in all three treatments arms at applicable visits to maintain masking among treatment arms.
Active Comparator: C: Aflibercept 2 mg Q8W Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.	Procedure: 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. It was administered to participants in all three treatments arms at applicable visits to maintain masking among treatment arms. Drug: Aflibercept Aflibercept 2 mg was administered by intravitreal (IVT) injection into the study eye once every 8 weeks (Q8W). Other Names: Eylea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations Time Frame: From Baseline through Week 56	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 letter score from baseline indicates an improvement in visual acuity. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment. An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. Invalid BCVA values were excluded. 97.5% CI is a rounding of 97.52% CI.	From Baseline through Week 56

Secondary Outcome Measures

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 9, 2018

Primary Completion (Actual)

October 19, 2020

Study Completion (Actual)

August 27, 2021

Study Registration Dates

First Submitted

August 1, 2018

First Submitted That Met QC Criteria

August 7, 2018

First Posted (Actual)

August 9, 2018

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

GR40398
2017-005105-12 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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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Ocugen

Not yet recruiting

Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME) (DME)

Diabetic Macular Edema | Center Involved Diabetic Macular Edema
California Retina Consultants
Regeneron Pharmaceuticals

Completed

Variable Interval Versus Set Interval Aflibercept for DME (EVADE)

Diabetic Macular Edema | Cystoid Macular Edema

United States
Oculis
ICON plc

Recruiting

Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema (DIAMOND-2)

Diabetic Macular Edema

United States
Novartis Pharmaceuticals

Not yet recruiting

Post Marketing Study to Evaluate the Safety and Effectiveness of Brolucizumab in Patients With Diabetic Macular Edema.

Diabetic Macular Edema
Vista Klinik

Not yet recruiting

Intravitreal Faricimab in Diabetic Macular Edema With Limited Response to Aflibercept

Diabetic Macular Edema
Chinese University of Hong Kong

Recruiting

Comparing Conventional Grid Laser Photocoagulation and Subthreshold Micropulse Laser in Diabetic Macular Edema Using OCT Angiography

Diabetic Macular Edema

China
Laboratorios Sophia S.A de C.V.

Recruiting

Clinical Study to Evaluate PRO-169 for Diabetic Macular Edema (PRO-169)

Diabetic Macular Edema

Colombia, Mexico
Centre Hospitalier Universitaire Dijon

Recruiting

Medico Economic Evaluation of Fluocinolone Acetonide Implant Versus Dexametheasone Implant in Resistant Diabetic Macular Oedema (EMMA)

Diabetic Macular Edema

France
Uptown Eye Specialists

Not yet recruiting

Ozurdex in Suboptimal Diabetic Macular Edema Patients (DME)

Diabetic Macular Edema
Hospices Civils de Lyon

Recruiting

Pilot and Phase 2 Study of the Efficacy of a Treatment Protocol With Dexamethasone Implant Loading Dose in Patients With Diabetic Macular Edema (LOADEX) (LOADEX)

Diabetic Macular Edema

France

Clinical Trials on Faricimab

Hoffmann-La Roche

Completed

A Study in Patients With Neovascular Age-Related Macular Degeneration or Diabetic Macular Edema to Evaluate the Safety of the Faricimab Prefilled Syringe

Diabetic Macular Edema | Neovascular Age-related Macular Degeneration

United States
University of Colorado, Denver

Not yet recruiting

Pre-operative Vabysmo in Patients With Non-clearing Vitreous Hemorrhage Secondary to Proliferative Diabetic Retinopathy

Diabetic Retinopathy | Vitreous Hemorrhage Due to Diabetes Mellitus
Jaeb Center for Health Research
Juvenile Diabetes Research Foundation; National Eye Institute (NEI); National...

Recruiting

Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD (AO)

Neovascular Age-related Macular Degeneration

United States
Medical University of Graz

Active, not recruiting

Faricimab for High-frequent Aflibercept Treated Neovascular Age-related Macular Degeneration (FAN)

Neovascular Age-related Macular Degeneration

Austria
Hoffmann-La Roche
Chugai Pharmaceutical

Completed

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

Central Retinal Vein Occlusion | Macular Edema | Hemiretinal Vein Occlusion

United States, Korea, Republic of, Brazil, Japan, United Kingdom, China, Argentina, Australia, France, Hungary, Italy, Poland, Spain, Singapore, Austria, Czechia, Germany, Hong Kong, Israel, Portugal, Russian Federation, Taiwan
Vista Klinik

Not yet recruiting

Intravitreal Faricimab in Diabetic Macular Edema With Limited Response to Aflibercept

Diabetic Macular Edema
Hoffmann-La Roche

Recruiting

A Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia (POYANG)

Choroidal Neovascularization Secondary to Pathologic Myopia

Korea, Republic of, China, Australia, Poland, Germany, Taiwan, Hong Kong
Hoffmann-La Roche
Chugai Pharmaceutical

Completed

A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion (BALATON)

Macular Edema | Branch Retinal Vein Occlusion

United States, Korea, Republic of, Brazil, Japan, United Kingdom, China, Argentina, Australia, France, Germany, Hungary, Italy, Poland, Spain, Singapore, Austria, Czechia, Hong Kong, Israel, Portugal, Russian Federation, Taiwan
Hoffmann-La Roche

Completed

A Study to Investigate Aqueous Humor and Multimodal Imaging Biomarkers in Treatment-Naïve Participants With Diabetic Macular Edema Treated With Faricimab (ALTIMETER)

Diabetic Macular Edema

Germany, United States, United Kingdom, Argentina, Canada, Italy, Poland
Greater Houston Retina Research
Genentech, Inc.

Active, not recruiting

Safety and Efficacy of Faricimab in Patients With NPDR (MAGIC)

Non-Proliferative Diabetic Retinopathy

United States

A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (RHINE)

A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (RHINE)

Study Overview

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Conditions

Intervention / Treatment

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Enrollment (Actual)

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Design Details

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Primary Outcome Measures

Outcome Measure

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Secondary Outcome Measures

Outcome Measure

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Time Frame

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Study Completion (Actual)

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First Posted (Actual)

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Last Update Posted (Actual)

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Last Verified

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Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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