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)

Use our guide to learn which trials are right for you!

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
sites
New York, New York 10021
?
mi
from
New York, NY
Click here to add this to my saved trials
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...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
98-1079 Moanalua Road
'Aiea, Hawaii 96701
?
mi
from
'Aiea, HI
Click here to add this to my saved trials
5441 Health Center Drive
Abilene, Texas 79606
?
mi
from
Abilene, TX
Click here to add this to my saved trials
Albany, New York 12206
?
mi
from
Albany, NY
Click here to add this to my saved trials
Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Asheville, North Carolina 28803
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Austin, Texas 78705
?
mi
from
Austin, TX
Click here to add this to my saved trials
Baltimore, Maryland 21209
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
600 North Wolfe Street
Baltimore, Maryland 21287
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Boston, Massachusetts 02114
?
mi
from
Boston, MA
Click here to add this to my saved trials
Boston, Massachusetts 02215
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Burlington, VT
Click here to add this to my saved trials
Campbell, California 95008
?
mi
from
Campbell, CA
Click here to add this to my saved trials
6035 Fairview Road
Charlotte, North Carolina 28210
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
8 Ranoldo Terrace
Cherry Hill, New Jersey 08034
?
mi
from
Cherry Hill, NJ
Click here to add this to my saved trials
Chesterfield, Missouri 63017
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
Chevy Chase, Maryland 20815
?
mi
from
Chevy Chase, MD
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45242
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cleveland, Ohio 44122
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
5 West Sample Road
Deerfield Beach, Florida 33064
?
mi
from
Deerfield Beach, FL
Click here to add this to my saved trials
2625 Bolton Boone Drive
DeSoto, Texas 75115
?
mi
from
DeSoto, TX
Click here to add this to my saved trials
Dublin, Ohio 43016
?
mi
from
Dublin, OH
Click here to add this to my saved trials
7760 France Avenue South
Edina, Minnesota 55435
?
mi
from
Edina, MN
Click here to add this to my saved trials
?
mi
from
Edison, NJ
Click here to add this to my saved trials
Edmond, Oklahoma 73013
?
mi
from
Edmond, OK
Click here to add this to my saved trials
2516 Sheridan Road Southeast
Falls Church, Virginia 22046
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
Fort Myers, Florida 33907
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
Fresno, California 93720
?
mi
from
Fresno, CA
Click here to add this to my saved trials
1432 Kimbrough Road
Germantown, Tennessee 38138
?
mi
from
Germantown, TN
Click here to add this to my saved trials
Golden, Colorado 80401
?
mi
from
Golden, CO
Click here to add this to my saved trials
Grand Rapids, Michigan 49546
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
?
mi
from
Graz,
Click here to add this to my saved trials
Hagerstown, Maryland 21740
?
mi
from
Hagerstown, MD
Click here to add this to my saved trials
200 Motor Parkway
Hauppauge, New York 11788
?
mi
from
Hauppauge, NY
Click here to add this to my saved trials
Houston, Texas 77025
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46290
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Lexington, Kentucky 40509
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Los Angeles, California
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Lynchburg, Virginia 24502
?
mi
from
Lynchburg, VA
Click here to add this to my saved trials
Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
?
mi
from
Madison, WI
Click here to add this to my saved trials
Marietta, Georgia 30060
?
mi
from
Marietta, GA
Click here to add this to my saved trials
McAllen, Texas 78503
?
mi
from
McAllen, TX
Click here to add this to my saved trials
Morgantown, West Virginia 26506
?
mi
from
Morgantown, WV
Click here to add this to my saved trials
1800 Republic Road
Norfolk, Virginia 23451
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
1500 Tilton Road
Northfield, New Jersey 08225
?
mi
from
Northfield, NJ
Click here to add this to my saved trials
Oakland, California 94609
?
mi
from
Oakland, CA
Click here to add this to my saved trials
Paducah, Kentucky 42001
?
mi
from
Paducah, KY
Click here to add this to my saved trials
Palm Beach Gardens, Florida 33410
?
mi
from
Palm Beach Gardens, FL
Click here to add this to my saved trials
36949 Cook Street
Palm Desert, California 92211
?
mi
from
Palm Desert, CA
Click here to add this to my saved trials
Palo Alto, California 94303
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
Pasadena, California 91107
?
mi
from
Pasadena, CA
Click here to add this to my saved trials
Pensacola, Florida 32503
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Portland, Maine
?
mi
from
Portland, ME
Click here to add this to my saved trials
Portland, Oregon 97210
?
mi
from
Portland, OR
Click here to add this to my saved trials
Poway, California 92064
?
mi
from
Poway, CA
Click here to add this to my saved trials
Rapid City, South Dakota 57701
?
mi
from
Rapid City, SD
Click here to add this to my saved trials
Redlands, California 92374
?
mi
from
Redlands, CA
Click here to add this to my saved trials
Reno, Nevada 89502
?
mi
from
Reno, NV
Click here to add this to my saved trials
Riverside, California 92505
?
mi
from
Riverside, CA
Click here to add this to my saved trials
Royal Oak, Michigan 48073
?
mi
from
Royal Oak, MI
Click here to add this to my saved trials
Sacramento, California 95817
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Salt Lake City, Utah
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
9157 Huebner Road
San Antonio, Texas 78240
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
1445 Bush Street
San Francisco, California 94107
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Santa Ana, California 92705
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Shawnee Mission, Kansas 66204
?
mi
from
Shawnee Mission, KS
Click here to add this to my saved trials
Shirley, New York 11967
?
mi
from
Shirley, NY
Click here to add this to my saved trials
Southern Pines, North Carolina 28387
?
mi
from
Southern Pines, NC
Click here to add this to my saved trials
Spokane, Washington 99204
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Sun City, Arizona 85351
?
mi
from
Sun City, AZ
Click here to add this to my saved trials
3107 East Genesee Street
Syracuse, New York 13224
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
2439 Care Drive
Tallahassee, Florida 32308
?
mi
from
Tallahassee, FL
Click here to add this to my saved trials
Tampa, Florida 33609
?
mi
from
Tampa, FL
Click here to add this to my saved trials
628 Cedar Lane
Teaneck, New Jersey 07666
?
mi
from
Teaneck, NJ
Click here to add this to my saved trials
The Woodlands, Texas 77384
?
mi
from
The Woodlands, TX
Click here to add this to my saved trials
Traverse City, Michigan 49586
?
mi
from
Traverse City, MI
Click here to add this to my saved trials
Tucson, Arizona 85724
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Tyler, Texas 75701
?
mi
from
Tyler, TX
Click here to add this to my saved trials
Warrenton, Virginia 20186
?
mi
from
Warrenton, VA
Click here to add this to my saved trials
West Des Moines, Iowa 50266
?
mi
from
West Des Moines, IA
Click here to add this to my saved trials
Wichita, Kansas 67214
?
mi
from
Wichita, KS
Click here to add this to my saved trials
Willow Park, Texas 76087
?
mi
from
Willow Park, TX
Click here to add this to my saved trials
Winston-Salem, North Carolina 27104
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
Winston-Salem, North Carolina 27157
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
Worcester, Massachusetts 01605
?
mi
from
Worcester, MA
Click here to add this to my saved trials