A Study of Faricimab (RO6867461) in Participants With Center-Involving Diabetic Macular Edema
NCT ID: NCT02699450
Last Updated: 2020-09-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
229 participants
INTERVENTIONAL
2016-04-27
2017-12-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm A: 0.3 mg Ranibizumab
Participants will receive 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant meets pre-specified criteria the participant will receive a single dose of 0.3 mg ranibizumab and exit the study.
Ranibizumab
Ranibizumab will be administered by IVT injection in the study eye.
Arm B: 1.5 mg Faricimab
Participants will receive 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant meets pre-specified criteria the participant will receive a single dose of 0.3 mg ranibizumab and exit the study.
Faricimab
Faricimab will be administered by IVT injection in the study eye.
Arm C: 6 mg Faricimab
Participants will receive 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant meets pre-specified criteria the participant will receive a single dose of 0.3 mg ranibizumab and exit the study.
Faricimab
Faricimab will be administered by IVT injection in the study eye.
Interventions
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Faricimab
Faricimab will be administered by IVT injection in the study eye.
Ranibizumab
Ranibizumab will be administered by IVT injection in the study eye.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Decreased visual acuity attributable primarily to DME
* Diagnosis of diabetes mellitus
Exclusion Criteria
* Cataract surgery within 3 months of Baseline, or any other previous intraocular surgery
* Uncontrolled glaucoma
* Current or history of ocular disease in the study eye other than DME
* Major illness or major surgical procedure within 1 month prior to Day 1
* Uncontrolled blood pressure
* Glycosylated hemoglobin (HbA1c) greater than (\>) 12 percent (%) at screening
* Untreated diabetes mellitus or initiation of oral anti-diabetic medication or insulin within 4 months prior to Day 1
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Retinal Research Institute, LLC
Phoenix, Arizona, United States
Associated Retina Consultants
Phoenix, Arizona, United States
Arizona Retina and Vitreous Consultants
Phoenix, Arizona, United States
Retina Associates Southwest PC
Tucson, Arizona, United States
Retina Consultants of Orange County
Fullerton, California, United States
United Med Res Inst
Inglewood, California, United States
Northern California Retina Vitreous Associates
Mountain View, California, United States
Ophthalmic Clinical Trials San Diego
Oceanside, California, United States
Southern CA Desert Retina Cons
Palm Desert, California, United States
Retina Consultants, San Diego
Poway, California, United States
Retinal Consultants Med Group
Sacramento, California, United States
California Retina Consultants
Santa Barbara, California, United States
Bay Area Retina Associates
Walnut Creek, California, United States
Retina Consultants of Southern
Colorado Springs, Colorado, United States
Rand Eye
Deerfield Beach, Florida, United States
National Ophthalmic Research Institute
Fort Myers, Florida, United States
Florida Eye Associates
Melbourne, Florida, United States
Retina Specialty Institute
Pensacola, Florida, United States
Retina Vitreous Assoc of FL
St. Petersburg, Florida, United States
Southern Vitreoretinal Assoc
Tallahassee, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
Georgia Retina PC
Marietta, Georgia, United States
Univ of Illinois at Chicago
Chicago, Illinois, United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, United States
Illinois Retina Associates SC
Oak Park, Illinois, United States
Midwest Eye Institute
Indianapolis, Indiana, United States
Wolfe Eye Clinic
West Des Moines, Iowa, United States
Retina Associates of Kentucky
Lexington, Kentucky, United States
Paducah Retinal Center
Paducah, Kentucky, United States
Wilmer Eye Institute
Baltimore, Maryland, United States
Vitreo-Retinal Associates
Grand Rapids, Michigan, United States
Vitreoretinal Surgery
Edina, Minnesota, United States
Sierra Eye Associates
Reno, Nevada, United States
Retina Center of New Jersey
Bloomfield, New Jersey, United States
Eye Associates of New Mexico
Albuquerque, New Mexico, United States
University of New Mexico
Albuquerque, New Mexico, United States
Capital Region Retina
Albany, New York, United States
Opthalmic Consultants of LI
Lynbrook, New York, United States
Retina Consultants of Western New York
Orchard Park, New York, United States
Western Carolina Retinal Associate PA
Asheville, North Carolina, United States
Char Eye Ear &Throat Assoc
Charlotte, North Carolina, United States
Cleveland Clinic Foundation; Cole Eye Institute
Cleveland, Ohio, United States
OSU Eye Physicians & Surgeons
Columbus, Ohio, United States
Oregon Retina, LLP
Eugene, Oregon, United States
Retina Northwest
Portland, Oregon, United States
Palmetto Retina Center
Florence, South Carolina, United States
Charleston Neuroscience Inst
Ladson, South Carolina, United States
Charles Retina Institute
Germantown, Tennessee, United States
Tennessee Retina PC.
Nashville, Tennessee, United States
W Texas Retina Consultants PA
Abilene, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Retina Consultants of Austin
Austin, Texas, United States
Retina Specialists
DeSoto, Texas, United States
Retina Consultants of Houston
Houston, Texas, United States
Med Center Ophthalmology Assoc
San Antonio, Texas, United States
Retina Consultants of Houston
The Woodlands, Texas, United States
Retina Associates of Utah
Salt Lake City, Utah, United States
Univ of Virginia Ophthalmology
Charlottesville, Virginia, United States
Spokane Eye Clinical Research
Spokane, Washington, United States
West Virginia University Eye Institute
Morgantown, West Virginia, United States
Countries
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References
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Sahni J, Patel SS, Dugel PU, Khanani AM, Jhaveri CD, Wykoff CC, Hershberger VS, Pauly-Evers M, Sadikhov S, Szczesny P, Schwab D, Nogoceke E, Osborne A, Weikert R, Fauser S. Simultaneous Inhibition of Angiopoietin-2 and Vascular Endothelial Growth Factor-A with Faricimab in Diabetic Macular Edema: BOULEVARD Phase 2 Randomized Trial. Ophthalmology. 2019 Aug;126(8):1155-1170. doi: 10.1016/j.ophtha.2019.03.023. Epub 2019 Mar 21.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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RG7716
Identifier Type: OTHER
Identifier Source: secondary_id
BP30099
Identifier Type: -
Identifier Source: org_study_id
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