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



Status:Recruiting
Conditions:Cardiology, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:3/13/2019
Start Date:September 5, 2018
End Date:June 2, 2022
Contact:Reference Study ID Number: GR40349 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. Only)

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

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).


Inclusion Criteria:

- Type 1 or type 2 diabetes mellitus and hemoglobin A1c (HbA1c) of less than or equal to
(≤) 10%

- 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 anti-diabetic medication or insulin 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
We found this trial at
92
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Chesterfield, Missouri 63017
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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98-1079 Moanalua Road
'Aiea, Hawaii 96701
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5441 Health Center Drive
Abilene, Texas 79606
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Albany, New York 12206
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Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Asheville, North Carolina 28803
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Austin, Texas 78705
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Baltimore, Maryland 21209
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600 North Wolfe Street
Baltimore, Maryland 21287
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Boston, Massachusetts 02114
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Boston, Massachusetts 02215
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Campbell, California 95008
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6035 Fairview Road
Charlotte, North Carolina 28210
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8 Ranoldo Terrace
Cherry Hill, New Jersey 08034
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Chevy Chase, Maryland 20815
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Cincinnati, Ohio 45242
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Cleveland, Ohio 44122
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Dallas, Texas 75231
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5 West Sample Road
Deerfield Beach, Florida 33064
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2625 Bolton Boone Drive
DeSoto, Texas 75115
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Dublin, Ohio 43016
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7760 France Avenue South
Edina, Minnesota 55435
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Edmond, Oklahoma 73013
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2516 Sheridan Road Southeast
Falls Church, Virginia 22046
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Fort Myers, Florida 33907
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Fresno, California 93720
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1432 Kimbrough Road
Germantown, Tennessee 38138
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Golden, Colorado 80401
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Grand Rapids, Michigan 49546
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Hagerstown, Maryland 21740
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200 Motor Parkway
Hauppauge, New York 11788
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Houston, Texas 77025
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Indianapolis, Indiana 46290
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Lynchburg, Virginia 24502
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Madison, Wisconsin 53792
(608) 263-2400
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Marietta, Georgia 30060
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McAllen, Texas 78503
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Morgantown, West Virginia 26506
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New York, New York 10021
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1800 Republic Road
Norfolk, Virginia 23451
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1500 Tilton Road
Northfield, New Jersey 08225
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Oakland, California 94609
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Paducah, Kentucky 42001
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Palm Beach Gardens, Florida 33410
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36949 Cook Street
Palm Desert, California 92211
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Palo Alto, California 94303
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Pensacola, Florida 32503
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Redlands, California 92374
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Sacramento, California 95817
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9157 Huebner Road
San Antonio, Texas 78240
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1445 Bush Street
San Francisco, California 94107
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Santa Ana, California 92705
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Shawnee Mission, Kansas 66204
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Shirley, New York 11967
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Southern Pines, North Carolina 28387
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Spokane, Washington 99204
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Sun City, Arizona 85351
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3107 East Genesee Street
Syracuse, New York 13224
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2439 Care Drive
Tallahassee, Florida 32308
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Tampa, Florida 33609
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628 Cedar Lane
Teaneck, New Jersey 07666
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The Woodlands, Texas 77384
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Traverse City, Michigan 49586
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Tyler, Texas 75701
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Winston-Salem, North Carolina 27104
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Winston-Salem, North Carolina 27157
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Worcester, Massachusetts 01605
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