Clinical trial NCT03622593: A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Macular Edema
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2018-08-09
Enrollment: 951
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
timeFrame: From Baseline through Week 56
Secondary outcomes:
measure: Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity (DRS) Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) at Week 52, ITT and Treatment-Naive Populations
timeFrame: Baseline and Week 52
measure: Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
measure: Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
measure: Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population
timeFrame: Baseline, average of Weeks 48, 52, and 56
measure: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
measure: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
measure: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
measure: Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
measure: Percentage of Participants Gaining ≥15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population
timeFrame: Baseline, average of Weeks 48, 52, and 56
measure: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
measure: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
measure: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
measure: Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
measure: Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population
timeFrame: Baseline, average of Weeks 48, 52, and 56
measure: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
measure: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
measure: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
measure: Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population
timeFrame: Baseline, average of Weeks 48, 52, and 56
measure: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
measure: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
measure: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
measure: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
timeFrame: Baseline, average of Weeks 48, 52, and 56
measure: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
measure: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
measure: Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
timeFrame: Baseline, average of Weeks 48, 52, and 56
measure: Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
measure: Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
measure: Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
timeFrame: Baseline, average of Weeks 48, 52, and 56
measure: Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
measure: Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
measure: Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population
timeFrame: Baseline, Weeks 16, 52, and 96
measure: Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population
timeFrame: Baseline, Weeks 16, 52, and 96
measure: Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population
timeFrame: Baseline, Weeks 16, 52, and 96
measure: Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population
timeFrame: Baseline, Weeks 16, 52, and 96
measure: Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population
timeFrame: Baseline, Weeks 16, 52, and 96
measure: Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population
timeFrame: Baseline, Weeks 16, 52, and 96
measure: Percentage of Participants Without Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed New PDR at Week 52, ITT and Treatment-Naive Populations
timeFrame: Baseline and Week 52
measure: Percentage of Participants Without High-Risk Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed High-Risk PDR at Week 52, ITT and Treatment-Naive Populations
timeFrame: Baseline and Week 52
measure: Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, ITT Population
timeFrame: Week 52
measure: Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, Treatment-Naive Population
timeFrame: Week 52
measure: Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, ITT Population
timeFrame: Week 96
measure: Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, Treatment-Naive Population
timeFrame: Week 96
measure: Percentage of Participants in the Faricimab 6 mg PTI Arm at Week 52 Who Achieved a Once Every 12-Weeks or 16-Weeks Treatment Interval Without an Interval Decrease Below Once Every 12 Weeks, ITT and Treatment-Naive Populations
timeFrame: From start of PTI (Week 12 or later) until Week 52
measure: Percentage of Participants in the Faricimab 6 mg PTI Arm at Week 96 Who Achieved a Once Every 12-Weeks or 16-Weeks Treatment Interval Without an Interval Decrease Below Once Every 12 Weeks, ITT and Treatment-Naive Populations
timeFrame: From start of PTI (Week 12 or later) until Week 96
measure: Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
timeFrame: From Baseline through Week 56
measure: Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
measure: Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
measure: Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
timeFrame: Average of Weeks 48, 52, and 56
measure: Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
measure: Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
measure: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population
timeFrame: Baseline, Weeks 16, 48, 52, 56, 92, 96, and 100
measure: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population
timeFrame: Baseline, Weeks 16, 48, 52, 56, 92, 96, and 100
measure: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population
timeFrame: Baseline, Weeks 16, 48, 52, 56, 92, 96, and 100
measure: Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time, ITT Population
timeFrame: Baseline, Weeks 24, 52, and 100
measure: Percentage of Participants With at Least One Adverse Event
timeFrame: From first dose of study drug through end of study (up to 2 years)
measure: Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
timeFrame: From first dose of study drug through end of study (up to 2 years)
measure: Percentage of Participants With at Least One Non-Ocular Adverse Event
timeFrame: From first dose of study drug through end of study (up to 2 years)
measure: Plasma Concentration of Faricimab Over Time
timeFrame: Pre-dose on Day 1 (Baseline); Weeks 4, 28, 52, 76, and 100
measure: Percentage of Participants Who Test Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study
timeFrame: Baseline, Weeks 4, 28, 52, 76, and 100
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Research Institute, LLC
state: Arizona
city: Phoenix
country: United States
facility: Associated Retina Consultants
state: Arizona
city: Springdale
country: United States
facility: Northwest Arkansas Retina Associates
state: Arkansas
city: Bakersfield
country: United States
facility: California Retina Consultants
state: California
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Encino
country: United States
facility: The Retina Partners
state: California
city: Fullerton
country: United States
facility: Retina Consultants of Orange County
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Med Group
state: California
city: Santa Barbara
country: United States
facility: California Retina Consultants
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates
state: California
city: Aurora
country: United States
facility: University of Colorado; dept of ophthalmology
state: Colorado
city: Colorado Springs
country: United States
facility: Retina Consultants of Southern
state: Colorado
city: Waterford
country: United States
facility: Retina Group of New England
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Retina Group of Florida
state: Florida
city: Fort Myers
country: United States
facility: National Ophthalmic Research Institute
state: Florida
city: Melbourne
country: United States
facility: Florida Eye Associates
state: Florida
city: Palm Beach Gardens
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
city: Plantation
country: United States
facility: Fort Lauderdale Eye Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Assoc of FL
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: Oak Forest
country: United States
facility: University Retina and Macula Associates, PC
state: Illinois
city: Springfield
country: United States
facility: Prairie Retina Center
state: Illinois
city: Towson
country: United States
facility: Retina Specialists
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center; Ophthalmology
state: Massachusetts
city: Grand Rapids
country: United States
facility: Associated Retinal Consultants
state: Michigan
city: Grand Rapids
country: United States
facility: Vitreo-Retinal Associates
state: Michigan
city: Las Vegas
country: United States
facility: Retina Consultants of Nevada
state: Nevada
city: Bloomfield
country: United States
facility: Envision Ocular, LLC
state: New Jersey
city: Hauppauge
country: United States
facility: Long Is. Vitreoretinal Consult
state: New York
city: New York
country: United States
facility: New York University
state: New York
city: Oceanside
country: United States
facility: Ophthalmic Cons of Long Island
state: New York
city: Rochester
country: United States
facility: Retina Assoc of Western NY
state: New York
city: Rochester
country: United States
facility: University of Rochester Flaum Eye Institute
state: New York
city: Slingerlands
country: United States
facility: The Retina Consultants
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation; Cole Eye Institute
state: Ohio
city: Philadelphia
country: United States
facility: Mid Atlantic Retina - Wills Eye Hospital
state: Pennsylvania
city: Greenville
country: United States
facility: Retina Consultants Of Carolina
state: South Carolina
city: Ladson
country: United States
facility: Charleston Neuroscience Inst
state: South Carolina
city: West Columbia
country: United States
facility: Palmetto Retina Center
state: South Carolina
city: Chattanooga
country: United States
facility: Southeastern Retina Associates Chattanooga
state: Tennessee
city: Knoxville
country: United States
facility: Southeastern Retina Associates
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Retina PC
state: Tennessee
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Southlake
country: United States
facility: Retina Center of Texas
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Charlottesville
country: United States
facility: Univ of Virginia Ophthalmology
state: Virginia
city: Richmond
country: United States
facility: Retina Institute of Virginia
state: Virginia
city: Silverdale
country: United States
facility: Retina Center Northwest
state: Washington
city: Caba
country: Argentina
facility: Fundacion Zambrano
city: Capital Federal
country: Argentina
facility: Oftalmos
city: Mendoza
country: Argentina
facility: Oftar
city: Rosario
country: Argentina
facility: Centro Oftalmólogos Especialistas
city: Rosario
country: Argentina
facility: Grupo Laser Vision
city: San Nicolás
country: Argentina
facility: Organizacion Medica de Investigacion
city: Strathfield
country: Australia
facility: Strathfield Retina Clinic
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Eye Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Retina Clinic and Day Surgery
state: New South Wales
city: Westmead
country: Australia
facility: Sydney West Retina
state: New South Wales
city: East Melbourne
country: Australia
facility: Centre For Eye Research Australia
state: Victoria
city: Rowville
country: Australia
facility: Retina Specialists Victoria
state: Victoria
city: Nedlands
country: Australia
facility: The Lions Eye Institute
state: Western Australia
city: Aparecida de Goiania
country: Brazil
facility: Hospital de Olhos de Aparecida - HOA
state: GO
city: Goiania
country: Brazil
facility: Centro Brasileiro de Cirurgia
state: GO
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: RS
city: Blumenau
country: Brazil
facility: Botelho Hospital da Visao
state: SC
city: Santo Andre
country: Brazil
facility: Faculdade de Medicina do ABC - FMABC
state: SP
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia
state: SP
city: Sao Paulo
country: Brazil
facility: CEMAPE - Centro Médico
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas - FMUSP
state: SP
city: Sorocaba
country: Brazil
facility: Hosp de Olhos de Sorocaba
state: SP
city: Calgary
country: Canada
facility: Calgary Retina Consultants
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia - Vancouver Coastal Health Authority
state: British Columbia
city: Halifax
country: Canada
facility: QEII - HSC Department of Ophthalmology
state: Nova Scotia
city: Etobicoke
country: Canada
facility: Vitreous Retina Macula Specialists of Toronto
state: Ontario
city: London
country: Canada
facility: Ivey Eye Institute
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Eye Institute
state: Ontario
city: Toronto
country: Canada
facility: Toronto Retina Institute
state: Ontario
city: Toronto
country: Canada
facility: Unity Health Toronto
state: Ontario
city: Toronto
country: Canada
facility: University Health Network Toronto Western Hospital
state: Ontario
city: Boisbriand
country: Canada
facility: Institut De L'Oeil Des Laurentides
state: Quebec
city: Montreal
country: Canada
facility: Hôpital Maisonneuve - Rosemont
state: Quebec
city: Beijing City
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Beijing Friendship Hospital
city: Beijing
country: China
facility: Beijing Tongren Hospital
city: Changchun
country: China
facility: The Second Hospital of Jilin University
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Chongqing City
country: China
facility: Southwest Hospital , Third Military Medical University; Ophthalmology
city: Chongqing City
country: China
facility: Army Medical Center of PLA(Daping Hospital)
city: Guangzhou City
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
city: Nanjing City
country: China
facility: The Affiliated Eye Hospital of Nanjing Medical University
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
city: Shanghai
country: China
facility: Shanghai First People's Hospital
city: Tianjin City
country: China
facility: Tianjin Eye Hospital
city: Tianjin City
country: China
facility: Tianjin Medical University Eye Hospital
city: Wenzhou City
country: China
facility: Eye Hospital, Wenzhou Medical University
city: Wuxi
country: China
facility: Wuxi No.2 People's Hospital
city: Hradec Králové
country: Czechia
facility: FN Hradec Králové, O?ní klinika; Ophthalmology clinic
city: Ostrava
country: Czechia
facility: Faculty Hospital Ostrava; Ophthalmology clinic
city: Prague
country: Czechia
facility: Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic
city: Prague
country: Czechia
facility: AXON Clinical
city: Sokolov
country: Czechia
facility: Nemocnice Sokolov
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital; Øjenafdelingen
city: Glostrup
country: Denmark
facility: Rigshospitalet Glostrup; Afdeling for Øjensygdomme, Center for Forskning
city: Roskilde
country: Denmark
facility: Sjællands Universitetshospital, Roskilde; Øjenafdelingen
city: Creteil
country: France
facility: Chi De Creteil; Ophtalmologie
city: Dijon
country: France
facility: CHU Bocage; Ophtalmologie
city: Lyon cedex
country: France
facility: Hopital de la croix rousse; Ophtalmologie
city: Paris
country: France
facility: CHNO des Quinze Vingts; Ophtalmologie
city: Paris
country: France
facility: Centre Ophtalmologique; Imagerie et laser
city: St Cyr Sur Loire
country: France
facility: Centres Ophtalmologique St Exupéry; Ophtalmologie
city: Toulouse
country: France
facility: Hôpital PURPAN - CHU TOULOUSE; Ophtalmologie
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum des Saarlandes; Klinik für Augenheilkunde
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik
city: München
country: Germany
facility: LMU Klinikum der Universität, Augenklinik
city: München
country: Germany
facility: Klinikum rechts der Isar der TU München; Augenklinik
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg, Augenklinik und Poliklinik
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital; Department of Ophthalmology
city: Mongkok
country: Hong Kong
facility: Hong Kong Eye Hospital; CUHK Eye Centre
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont; Szemészeti Osztály
city: Budapest
country: Hungary
facility: Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Szemészeti Vizsgálóhely
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Hospital
city: Roma
country: Italy
facility: Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche
state: Lazio
city: Milano
country: Italy
facility: ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)
state: Lombardia
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica
state: Toscana
city: Pisa
country: Italy
facility: Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria
state: Toscana
city: Negrar - Verona
country: Italy
facility: Ospedale Classificato Equiparato Sacro Cuore ? Don Calabria; Dipartimento Oculistica
state: Veneto
city: Udine
country: Italy
facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica
state: Veneto
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center.
city: Bydgoszcz
country: Poland
facility: OFTALMIKA Sp. z o.o
city: Bydgoszcz
country: Poland
facility: Specjalistyczny O?rodek Okulistyczny Oculomedica
city: Gda?sk
country: Poland
facility: Optimum Profesorskie Centrum Okulistyki
city: Gliwice
country: Poland
facility: Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT
city: Krakow
country: Poland
facility: SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej
city: Rzeszów
country: Poland
facility: Osrodek Chirurgii Oka prof. Zagorskiego Rzeszow
city: Tarnowskie Góry
country: Poland
facility: Caminomed
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
city: Braga
country: Portugal
facility: Hospital de Braga; Servico de Oftalmologia
city: Coimbra
country: Portugal
facility: AIBILI - Association for Innovation and Biomedical Research on Light
city: Coimbra
country: Portugal
facility: Espaco Medico Coimbra
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria; Servico de Oftalmologia
city: Cheboksary
country: Russian Federation
facility: Intersec Research and Technology Complex ?Eye Microsurgery? n.a. S.N. Fyodorov; Cheboksary Branch
state: Marij EL
city: Kazan
country: Russian Federation
facility: Clinics of Eye Diseases, LLC
state: Tatarstan
city: Irkutsk
country: Russian Federation
facility: ?Intersec. Research and Technology Complex ?Eye Microsurgery? n a Fyodorov Irkutsk branch
city: Novosibirsk
country: Russian Federation
facility: ?Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch
city: Singapore
country: Singapore
facility: National University Hospital; Ophthalmology Department
city: Singapore
country: Singapore
facility: Singapore Eye Research Institute
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital; Ophthalmology Department
city: Oviedo
country: Spain
facility: Instituto Oftalmologico Fernandez Vega; Servicio de oftalmologia
state: Asturias
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: San Cugat Del Valles
country: Spain
facility: Hospital General de Catalunya
state: Barcelona
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra; Servicio de oftalmologia
state: Navarra
city: Burjassot
country: Spain
facility: Oftalvist Valencia
state: Valencia
city: Barcelona
country: Spain
facility: Institut de la Macula i la retina
city: Barcelona
country: Spain
facility: Hospital dos de maig; Pharmacy Service
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos; Servicio de oftalmologia
city: Madrid
country: Spain
facility: Clinica Baviera; Servicio Oftalmologia
city: Valencia
country: Spain
facility: Fisabio-Ofalmologia Medica; Servicio de Oftalmología
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia
city: Binningen
country: Switzerland
facility: Vista Klinik Ophthalmologische Klinik
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital; Ophthalmology
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation - Linkou; Ophthalmology
city: Zhongzheng Dist.
country: Taiwan
facility: National Taiwan University Hospital; Ophthalmology
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital; Ophthalmology Department
city: Bangkok
country: Thailand
facility: Rajavithi Hospital; Ophthalmology Department
city: ChiangMai
country: Thailand
facility: Maharaj Nakorn ChiangMai Hospital; Ophthalmology Department
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty; Department of Ophthalmology
city: Ankara
country: Turkey
facility: Ankara Baskent University Medical Faculty; Department of Ophthalmology
city: Istanbul
country: Turkey
facility: Beyoglu Goz Training and Research Hospital; Department Of Ophthalmology
city: Kocaeli
country: Turkey
facility: Kocaeli Üniversitesi T?p Fakültesi; Department of Ophthalmology
city: Barnet
country: United Kingdom
facility: Barnet Hospital; ROYAL FREE LONDON NHS FOUNDATION TRUST
city: Belfast
country: United Kingdom
facility: Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation Trust, Bristol Eye Hospital
city: Canterbury
country: United Kingdom
facility: East Kent Hospitals University NHS Foundation Trust
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital
city: Gloucestershire
country: United Kingdom
facility: Gloucestershire Hospitals NHS Foundation Trust
city: Leeds
country: United Kingdom
facility: St James University Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Kings College Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Eye Hospital
city: Middx
country: United Kingdom
facility: Hillingdon Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Norfolk
country: United Kingdom
facility: James Paget University Hospitals NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust; Southampton Eye Unit
city: Sunderland
country: United Kingdom
facility: Sunderland Eye Infirmary
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Eter N, Singh RP, Abreu F, Asik K, Basu K, Baumal C, Chang A, Csaky KG, Haskova Z, Lin H, Ruiz CQ, Ruamviboonsuk P, Silverman D, Wykoff CC, Willis JR. YOSEMITE and RHINE: Phase 3 Randomized Clinical Trials of Faricimab for Diabetic Macular Edema: Study Design and Rationale. Ophthalmol Sci. 2021 Dec 30;2(1):100111. doi: 10.1016/j.xops.2021.100111. eCollection 2022 Mar.
citation: Wykoff CC, Abreu F, Adamis AP, Basu K, Eichenbaum DA, Haskova Z, Lin H, Loewenstein A, Mohan S, Pearce IA, Sakamoto T, Schlottmann PG, Silverman D, Sun JK, Wells JA, Willis JR, Tadayoni R; YOSEMITE and RHINE Investigators. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. Lancet. 2022 Feb 19;399(10326):741-755. doi: 10.1016/S0140-6736(22)00018-6. Epub 2022 Jan 24.