Clinical trial NCT03622580: A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE)
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 (YOSEMITE)
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: 940
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 the past 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 Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale 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: Mesa
country: United States
facility: Barnet Dulaney Perkins Eye Center
state: Arizona
city: Phoenix
country: United States
facility: Arizona Retina and Vitreous Consultants
state: Arizona
city: Tucson
country: United States
facility: Retina Associates Southwest PC
state: Arizona
city: Campbell
country: United States
facility: Retinal Diagnostic Center
state: California
city: Fresno
country: United States
facility: Eye Medical Center
state: California
city: Oakland
country: United States
facility: East Bay Retina Consultants
state: California
city: Palm Desert
country: United States
facility: Southern CA Desert Retina Cons
state: California
city: Pasadena
country: United States
facility: California Eye Specialists Medical group Inc.
state: California
city: Poway
country: United States
facility: Retina Consultants, San Diego
state: California
city: Redlands
country: United States
facility: Retina Consultants of Southern California
state: California
city: Riverside
country: United States
facility: Kaiser Permanente Riverside Medical Center
state: California
city: Sacramento
country: United States
facility: University of California, Davis, Eye Center
state: California
city: San Francisco
country: United States
facility: W Coast Retina Med Group Inc
state: California
city: Santa Ana
country: United States
facility: Orange County Retina Med Group
state: California
city: Lakewood
country: United States
facility: Colorado Retina Associates, PC
state: Colorado
city: Deerfield Beach
country: United States
facility: Rand Eye
state: Florida
city: Palm Beach Gardens
country: United States
facility: Retina Care Specialists
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Tallahassee
country: United States
facility: Southern Vitreoretinal Assoc
state: Florida
city: Tampa
country: United States
facility: Retina Associates of Florida, LLC
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Marietta
country: United States
facility: Georgia Retina PC
state: Georgia
city: 'Aiea
country: United States
facility: Retina Consultants of Hawaii
state: Hawaii
city: Indianapolis
country: United States
facility: Midwest Eye Institute
state: Indiana
city: West Des Moines
country: United States
facility: Wolfe Eye Clinic
state: Iowa
city: Lenexa
country: United States
facility: Retina Associates
state: Kansas
city: Wichita
country: United States
facility: Vitreo-Retinal Consultants
state: Kansas
city: Lexington
country: United States
facility: Retina Associates of Kentucky
state: Kentucky
city: Paducah
country: United States
facility: Paducah Retinal Center
state: Kentucky
city: Portland
country: United States
facility: Maine Eye Center
state: Maine
city: Baltimore
country: United States
facility: The Retina Care Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Med; Wilmer Eye Inst
state: Maryland
city: Chevy Chase
country: United States
facility: Retina Group of Washington
state: Maryland
city: Hagerstown
country: United States
facility: Cumberland Valley Retina PC
state: Maryland
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Boston
country: United States
facility: Beetham Eye Institute, Joslin Diabetes Center
state: Massachusetts
city: Worcester
country: United States
facility: Vitreo-Retinal Associates, PC
state: Massachusetts
city: Grand Rapids
country: United States
facility: Foundation for Vision Research
state: Michigan
city: Royal Oak
country: United States
facility: Assoc Retinal Consultants PC
state: Michigan
city: Traverse City
country: United States
facility: Associated Retinal Consultants, P.C.
state: Michigan
city: Edina
country: United States
facility: Vitreoretinal Surgery
state: Minnesota
city: Chesterfield
country: United States
facility: Midwest Vision Research Foundation
state: Missouri
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Cherry Hill
country: United States
facility: Mid Atlantic Retina - Wills Eye Hospital
state: New Jersey
city: Edison
country: United States
facility: NJ Retina
state: New Jersey
city: Northfield
country: United States
facility: Retinal & Ophthalmic Cons PC
state: New Jersey
city: Teaneck
country: United States
facility: Retina Associates of NJ
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Albany
country: United States
facility: Capital Region Retina
state: New York
city: Great Neck
country: United States
facility: Long Is. Vitreoretinal Consult
state: New York
city: Liverpool
country: United States
facility: Retina Vit Surgeons/Central NY
state: New York
city: New York
country: United States
facility: MaculaCare, PLLC
state: New York
city: Shirley
country: United States
facility: Island Retina
state: New York
city: Asheville
country: United States
facility: Western Carolina Retinal Associate PA
state: North Carolina
city: Charlotte
country: United States
facility: Char Eye Ear &Throat Assoc
state: North Carolina
city: Hickory
country: United States
facility: Graystone Eye
state: North Carolina
city: Southern Pines
country: United States
facility: Carolina Eye Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Cleveland
country: United States
facility: Retina Assoc of Cleveland Inc
state: Ohio
city: Columbus
country: United States
facility: OSU Eye Physicians & Surgeons
state: Ohio
city: Dublin
country: United States
facility: Midwest Retina
state: Ohio
city: Edmond
country: United States
facility: Retina Vitreous Center
state: Oklahoma
city: Portland
country: United States
facility: Retina Northwest
state: Oregon
city: Rapid City
country: United States
facility: Black Hills Eye Institute
state: South Dakota
city: Memphis
country: United States
facility: Charles Retina Institute
state: Tennessee
city: Abilene
country: United States
facility: Retina Res Institute of Texas
state: Texas
city: Austin
country: United States
facility: Austin Clinical Research LLC
state: Texas
city: Bellaire
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: DeSoto
country: United States
facility: Retina Specialists
state: Texas
city: Harlingen
country: United States
facility: Valley Retina Institute P.A.
state: Texas
city: Houston
country: United States
facility: Retina & Vitreous of Texas
state: Texas
city: San Antonio
country: United States
facility: Med Center Ophthalmology Assoc
state: Texas
city: Tyler
country: United States
facility: Eye Care Assoc of East Texas
state: Texas
city: Willow Park
country: United States
facility: Strategic Clinical Research Group, LLC
state: Texas
city: Salt Lake City
country: United States
facility: Retina Associates of Utah
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah; Division of Gastroenterology/Hepatology
state: Utah
city: Burlington
country: United States
facility: University of Vermont Medical Center; Investigational Drug Service, Pharmacy Department/Baird 1
state: Vermont
city: Falls Church
country: United States
facility: Emerson Clinical Research Institute
state: Virginia
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
city: Norfolk
country: United States
facility: Wagner Macula & Retina Center
state: Virginia
city: Spokane
country: United States
facility: Spokane Eye Clinical Research
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Eye Institute
state: West Virginia
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Graz
country: Austria
facility: LKH-Univ.Klinikum Graz; Universitäts-Augenklinik
city: Linz
country: Austria
facility: Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde
city: Wien
country: Austria
facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie
city: Wien
country: Austria
facility: Hanusch Krankenhaus; Abteilung für Augenkrankheiten mit Augen-Tagesklinik
city: Sofia
country: Bulgaria
facility: Medical Center for Eye Health - Focus Ltd
city: Sofia
country: Bulgaria
facility: Pentagram Eye Hospital (Medical Center "Pentagram")
city: Sofia
country: Bulgaria
facility: Spec. Ophth. Hospital for Active Treatment- Academic Pashev
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Eye Diseases Zora
city: Varna
country: Bulgaria
facility: Ambulatory - Medical Center for Specialized Medical Assistance - "Eye Clinic Sveta Petka" Ltd
city: Bordeaux
country: France
facility: Hopital Pellegrin; Ophtalmologie
city: Ecully
country: France
facility: Pole Vision Val d'Ouest; Ophtalmologie
city: Marseille
country: France
facility: Centre Paradis Monticelli; Ophtalmologie
city: Nantes
country: France
facility: CHU Nantes - Hôtel Dieu; Ophthalmology
city: Paris
country: France
facility: Centre Odeon; Exploration Ophtalmologique
city: Paris
country: France
facility: Hopital Lariboisiere; Ophtalmologie
city: Bonn
country: Germany
facility: Universitäts-Augenklinik Bonn
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde 3.B1.266
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Klinik für Augenheilkunde
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik
city: Münster
country: Germany
facility: Augenabteilung am St. Franziskus-Hospital
city: Münster
country: Germany
facility: Universitätsklinikum Münster; Augenheilkunde
city: Budapest
country: Hungary
facility: Budapest Retina Associates Kft.
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
city: Pécs
country: Hungary
facility: Ganglion Medial Center
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem ÁOK; Department of Ophtalmology
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Kórház; SZEMESZET
city: Haifa
country: Israel
facility: Rambam Medical Center; Opthalmology
city: Jerusalem
country: Israel
facility: Hadassah MC; Ophtalmology
city: Petach Tikva
country: Israel
facility: Rabin MC; Ophtalmology
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky MC; Ophtalmology
city: Chieti
country: Italy
facility: Ospedale Clinicizzato SS Annunziata; Clinica Oftalmologica
state: Abruzzo
city: Roma
country: Italy
facility: Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
state: Lazio
city: Genova
country: Italy
facility: UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA
state: Liguria
city: Milano
country: Italy
facility: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica
state: Lombardia
city: Milano
country: Italy
facility: Irccs Ospedale San Raffaele;U.O. Oculistica
state: Lombardia
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia; Clinica Oculistica
state: Umbria
city: Aichi
country: Japan
facility: Sugita Eye Hospital
city: Aichi
country: Japan
facility: Nagoya University Hospital
city: Aichi
country: Japan
facility: Nagoya City University Hospital
city: Aichi
country: Japan
facility: Aichi Medical University Hospital
city: Chiba
country: Japan
facility: Toho University Sakura Medical Center
city: Fukuoka
country: Japan
facility: Hayashi Eye Hospital
city: Fukuoka
country: Japan
facility: Kurume University Hospital
city: Hokkaido
country: Japan
facility: Hokkaido University Hospital
city: Hokkaido
country: Japan
facility: Asahikawa Medical University Hospital
city: Hyogo
country: Japan
facility: Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)
city: Ibaraki
country: Japan
facility: Kozawa eye hospital and diabetes center
city: Kanagawa
country: Japan
facility: St. Marianna University Hospital
city: Kumamoto
country: Japan
facility: Ideta Eye Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Mie
country: Japan
facility: Mie University Hospital
city: Miyazaki
country: Japan
facility: University of Miyazaki Hospital
city: Nara
country: Japan
facility: Nara Medical University Hospital
city: Osaka
country: Japan
facility: Kitano Hospital
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Saitama
country: Japan
facility: National Defense Medical College Hospital
city: Shiga
country: Japan
facility: Shiga University Of Medical Science Hospital
city: Shizuoka
country: Japan
facility: Seirei Hamamatsu General Hospital
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University Hospital
city: Tokyo
country: Japan
facility: Kyorin University Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical University Hachioji Medical Center
city: Yamaguchi
country: Japan
facility: Yamaguchi University Hospital
city: Del. Cuauhtemoc
country: Mexico
facility: Centro Oftalmológico Mira, S.C
state: Mexico CITY (federal District)
city: Mexico, D.F.
country: Mexico
facility: Macula Retina Consultores
city: Mexico, D.F.
country: Mexico
facility: Hospital de la Ceguera APEC
city: Querétaro
country: Mexico
facility: Instituto Mexicano de Oftalmologia I.A.P.
city: Lima
country: Peru
facility: Mácula D&T
city: Lima
country: Peru
facility: Oftalmosalud Srl
city: Lima
country: Peru
facility: TG Laser Oftalmica
city: Lima
country: Peru
facility: Oftalmolaser
city: Bielsko-Biala
country: Poland
facility: Szpital sw. Lukasza
city: Bytom
country: Poland
facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki
city: Gdańsk
country: Poland
facility: Dobry Wzrok Sp Z O O
city: Katowice
country: Poland
facility: Gabinet Okulistyczny Prof Edward Wylegala
city: Krakow
country: Poland
facility: Centrum Medyczne UNO-MED
city: Rybnik
country: Poland
facility: Optomed Sp. z o.o.
city: Rzeszów
country: Poland
facility: Kliniczny Szpital Wojewodzki nr 1 im. F. Chopina; Klinika Okulistyki
city: Wroclaw
country: Poland
facility: SPEKTRUM Osrodek Okulistyki Klinicznej
city: UFA
country: Russian Federation
facility: Clinic Optimed
state: Baskortostan
city: Moscow
country: Russian Federation
facility: FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences
city: St.Petersburg
country: Russian Federation
facility: Medical Military Academy n.a S.M.Kirov
city: Trebišov
country: Slovakia
facility: Nemocnica s poliklinikou Trebišov, a.s.
city: Trencin
country: Slovakia
facility: Fakultna nemocnica Trencin Ocna klinika
city: Zilina
country: Slovakia
facility: Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie
city: Santiago de Compostela
country: Spain
facility: Instituto Oftalmologico Gomez Ulla; Servicio de Oftalmologia
state: LA Coruña
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria; Servicio de oftalmologia
state: LAS Palmas
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia
state: Navarra
city: Albacete
country: Spain
facility: Complejo Hospitalario Universitario Albacete; Servicio de oftalmologia
city: Alicante
country: Spain
facility: VISSUM Instituto Oftalmológico de Alicante
city: Barcelona
country: Spain
facility: Centro de Oftalmologia Barraquer; Servicio Oftalmologia
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona; Consultas Externas Oftalmologia
city: Barcelona
country: Spain
facility: Hospital de Santa Creu I Sant Pau; Servicio de Oftalmologia
city: Madrid
country: Spain
facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty; Department of Ophthalmology
city: Izmir
country: Turkey
facility: Ege University Medical Faculty; Department of Ophthalmology
city: Konya
country: Turkey
facility: Selcuk University Faculty of Medicine; Department Of Ophthalmology
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.