A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (TENAYA)



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:4/6/2019
Start Date:February 19, 2019
End Date:November 30, 2022
Contact:Reference Study ID Number: GR40306 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6782 (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 Faricimab in Patients With Neovascular Age-Related Macular Degeneration (TENAYA)

This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab
administered at intervals as specified in the protocol, compared with aflibercept once every
8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).


Inclusion Criteria:

- Treatment-naïve choroidal neovascularization (CNV) secondary to age-related macular
degeneration (nAMD) in the study eye

- Ability to comply with the study protocol, in the investigator's judgment

- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use acceptable contraceptive measures that result in
failure rate <1% per year during the treatment period and for at least 3 months after
the final dose of study treatment

- Other protocol-specified inclusion criteria may apply

Exclusion Criteria:

- Uncontrolled blood pressure, defined as systolic blood pressure >180 millimeters of
mercury (mmHg) and/or diastolic blood pressure >100 mmHg while a patient is at rest on
Day 1

- Pregnancy or breastfeeding, or intention to become pregnant during the study

- CNV due to causes other than AMD in the study eye

- Any history of macular pathology unrelated to AMD affecting vision or contributing to
the presence of intraretinal or subretinal fluid in the study eye

- Any concurrent intraocular condition in the study eye that, in the opinion of the
investigator, could either reduce the potential for visual improvement or require
medical or surgical intervention during the study

- Uncontrolled glaucoma in the study eye

- Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in
the study eye

- Prior IVT administration of faricimab in either eye

- History of idiopathic or autoimmune-associated uveitis in either eye

- Active ocular inflammation or suspected or active ocular or periocular infection in
either eye

- Other protocol-specified exclusion criteria may apply
We found this trial at
60
sites
Reno, Nevada 89502
1936
mi
from 43215
Reno, NV
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Asheville, North Carolina 28803
302
mi
from 43215
Asheville, NC
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Bakersfield, California 93309
1983
mi
from 43215
Bakersfield, CA
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600 North Wolfe Street
Baltimore, Maryland 21287
345
mi
from 43215
Baltimore, MD
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Bloomfield, New Jersey 07003
468
mi
from 43215
Bloomfield, NJ
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Boston, Massachusetts 02111
643
mi
from 43215
Boston, MA
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Calgary, Alberta
?
mi
from 43215
Calgary,
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Campbell, California 95008
2092
mi
from 43215
Campbell, CA
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6035 Fairview Road
Charlotte, North Carolina 28210
353
mi
from 43215
Charlotte, NC
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8 Ranoldo Terrace
Cherry Hill, New Jersey 08034
425
mi
from 43215
Cherry Hill, NJ
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1815 Clarkson Road
Chesterfield, Missouri 63017
413
mi
from 43215
Chesterfield, MO
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Chevy Chase, Maryland 20815
324
mi
from 43215
Chevy Chase, MD
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274
mi
from 43215
Chicago, IL
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Cincinnati, Ohio 45242
98
mi
from 43215
Cincinnati, OH
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2770 North Union Boulevard
Colorado Springs, Colorado 80909
1161
mi
from 43215
Colorado Springs, CO
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Dallas, Texas 75231
905
mi
from 43215
Dallas, TX
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5 West Sample Road
Deerfield Beach, Florida 33064
960
mi
from 43215
Deerfield Beach, FL
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455
mi
from 43215
Edison, NJ
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Encino, California 91436
1982
mi
from 43215
Encino, CA
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1224 Graham Road
Florissant, Missouri 63031
398
mi
from 43215
Florissant, MO
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1432 Kimbrough Road
Germantown, Tennessee 38138
499
mi
from 43215
Germantown, TN
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Grand Rapids, Michigan 45946
248
mi
from 43215
Grand Rapids, MI
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200 Motor Parkway
Hauppauge, New York 11788
517
mi
from 43215
Hauppauge, NY
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Houston, Texas 77025
991
mi
from 43215
Houston, TX
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Houston, Texas 77030
995
mi
from 43215
Houston, TX
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9415 Campus Point Drive
La Jolla, California 92093
1950
mi
from 43215
La Jolla, CA
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9551 U.S. 78
Ladson, South Carolina 29456
508
mi
from 43215
Ladson, SC
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Lexington, Kentucky 40509
154
mi
from 43215
Lexington, KY
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Los Angeles, California 90033
1972
mi
from 43215
Los Angeles, CA
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McAllen, Texas 78503
1291
mi
from 43215
McAllen, TX
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502 East New Haven Avenue
Melbourne, Florida 32901
832
mi
from 43215
Melbourne, FL
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Nashville, Tennessee 37203
333
mi
from 43215
Nashville, TN
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Palm Beach Gardens, Florida 33418
922
mi
from 43215
Palm Beach Gardens, FL
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36949 Cook Street
Palm Desert, California 92211
1879
mi
from 43215
Palm Desert, CA
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Pasadena, California 91107
1964
mi
from 43215
Pasadena, CA
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Pensacola, Florida 32503
700
mi
from 43215
Pensacola, FL
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Philadelphia, Pennsylvania 19104
414
mi
from 43215
Philadelphia, PA
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Phoenix, Arizona 85014
1660
mi
from 43215
Phoenix, AZ
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Plantation, Florida 33324
969
mi
from 43215
Plantation, FL
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Portland, Oregon 97210
2026
mi
from 43215
Portland, OR
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Poway, California 92064
1938
mi
from 43215
Poway, CA
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Rapid City, South Dakota 57701
1071
mi
from 43215
Rapid City, SD
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Redlands, California 92374
1914
mi
from 43215
Redlands, CA
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160 Sawgrass Drive
Rochester, New York 14620
354
mi
from 43215
Rochester, NY
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Rockville Centre, New York 11570
497
mi
from 43215
Rockville Centre, NY
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Sacramento, California 95817
2042
mi
from 43215
Sacramento, CA
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4344 Central Avenue North
Saint Petersburg, Florida 33711
842
mi
from 43215
Saint Petersburg, FL
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Salt Lake City, Utah 84107
1514
mi
from 43215
Salt Lake City, UT
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Shawnee Mission, Kansas 66204
624
mi
from 43215
Shawnee Mission, KS
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SLingerlands, New York 12159
509
mi
from 43215
SLingerlands, NY
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Southern Pines, North Carolina 28387
386
mi
from 43215
Southern Pines, NC
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Spokane, Washington 99204
1778
mi
from 43215
Spokane, WA
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601 Maple Drive
Springdale, Arkansas 72764
657
mi
from 43215
Springdale, AR
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Sun City, Arizona 85351
1668
mi
from 43215
Sun City, AZ
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3107 East Genesee Street
Syracuse, New York 13224
416
mi
from 43215
Syracuse, NY
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628 Cedar Lane
Teaneck, New Jersey 07666
477
mi
from 43215
Teaneck, NJ
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Tucson, Arizona 85724
1639
mi
from 43215
Tucson, AZ
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Waterford, Connecticut 06385
?
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Waterford, CT
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Winston-Salem, North Carolina 27104
306
mi
from 43215
Winston-Salem, NC
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Winston-Salem, North Carolina 27157
306
mi
from 43215
Winston-Salem, NC
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