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
Asheville, North Carolina 28803
2187
mi
from 98109
Asheville, NC
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Bakersfield, California 93309
865
mi
from 98109
Bakersfield, CA
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600 North Wolfe Street
Baltimore, Maryland 21287
2329
mi
from 98109
Baltimore, MD
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Bloomfield, New Jersey 07003
2390
mi
from 98109
Bloomfield, NJ
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Boston, Massachusetts 02111
2485
mi
from 98109
Boston, MA
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Calgary, Alberta
?
mi
from 98109
Calgary,
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Campbell, California 95008
715
mi
from 98109
Campbell, CA
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6035 Fairview Road
Charlotte, North Carolina 28210
2284
mi
from 98109
Charlotte, NC
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8 Ranoldo Terrace
Cherry Hill, New Jersey 08034
2382
mi
from 98109
Cherry Hill, NJ
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1815 Clarkson Road
Chesterfield, Missouri 63017
1703
mi
from 98109
Chesterfield, MO
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Chevy Chase, Maryland 20815
2317
mi
from 98109
Chevy Chase, MD
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1733
mi
from 98109
Chicago, IL
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Cincinnati, Ohio 45242
1967
mi
from 98109
Cincinnati, OH
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2770 North Union Boulevard
Colorado Springs, Colorado 80909
1066
mi
from 98109
Colorado Springs, CO
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Dallas, Texas 75231
1678
mi
from 98109
Dallas, TX
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5 West Sample Road
Deerfield Beach, Florida 33064
2710
mi
from 98109
Deerfield Beach, FL
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2389
mi
from 98109
Edison, NJ
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Encino, California 91436
952
mi
from 98109
Encino, CA
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1224 Graham Road
Florissant, Missouri 63031
1709
mi
from 98109
Florissant, MO
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1432 Kimbrough Road
Germantown, Tennessee 38138
1877
mi
from 98109
Germantown, TN
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Grand Rapids, Michigan 45946
1793
mi
from 98109
Grand Rapids, MI
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200 Motor Parkway
Hauppauge, New York 11788
2433
mi
from 98109
Hauppauge, NY
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Houston, Texas 77025
1890
mi
from 98109
Houston, TX
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Houston, Texas 77030
1892
mi
from 98109
Houston, TX
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9415 Campus Point Drive
La Jolla, California 92093
1053
mi
from 98109
La Jolla, CA
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9551 U.S. 78
Ladson, South Carolina 29456
2407
mi
from 98109
Ladson, SC
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Lexington, Kentucky 40509
2010
mi
from 98109
Lexington, KY
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Los Angeles, California 90033
962
mi
from 98109
Los Angeles, CA
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McAllen, Texas 78503
1974
mi
from 98109
McAllen, TX
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502 East New Haven Avenue
Melbourne, Florida 32901
2603
mi
from 98109
Melbourne, FL
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Nashville, Tennessee 37203
1971
mi
from 98109
Nashville, TN
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Palm Beach Gardens, Florida 33418
2683
mi
from 98109
Palm Beach Gardens, FL
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36949 Cook Street
Palm Desert, California 92211
1006
mi
from 98109
Palm Desert, CA
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Pasadena, California 91107
956
mi
from 98109
Pasadena, CA
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Pensacola, Florida 32503
2200
mi
from 98109
Pensacola, FL
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Philadelphia, Pennsylvania 19104
2371
mi
from 98109
Philadelphia, PA
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Phoenix, Arizona 85014
1113
mi
from 98109
Phoenix, AZ
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Plantation, Florida 33324
2712
mi
from 98109
Plantation, FL
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Portland, Oregon 97210
147
mi
from 98109
Portland, OR
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Poway, California 92064
1050
mi
from 98109
Poway, CA
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Rapid City, South Dakota 57701
949
mi
from 98109
Rapid City, SD
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Redlands, California 92374
974
mi
from 98109
Redlands, CA
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Reno, Nevada 89502
578
mi
from 98109
Reno, NV
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160 Sawgrass Drive
Rochester, New York 14620
2162
mi
from 98109
Rochester, NY
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Rockville Centre, New York 11570
2420
mi
from 98109
Rockville Centre, NY
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Sacramento, California 95817
629
mi
from 98109
Sacramento, CA
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4344 Central Avenue North
Saint Petersburg, Florida 33711
2525
mi
from 98109
Saint Petersburg, FL
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Salt Lake City, Utah 84107
706
mi
from 98109
Salt Lake City, UT
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Shawnee Mission, Kansas 66204
1503
mi
from 98109
Shawnee Mission, KS
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SLingerlands, New York 12159
2348
mi
from 98109
SLingerlands, NY
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Southern Pines, North Carolina 28387
2350
mi
from 98109
Southern Pines, NC
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Spokane, Washington 99204
229
mi
from 98109
Spokane, WA
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601 Maple Drive
Springdale, Arkansas 72764
1639
mi
from 98109
Springdale, AR
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Sun City, Arizona 85351
1102
mi
from 98109
Sun City, AZ
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3107 East Genesee Street
Syracuse, New York 13224
2234
mi
from 98109
Syracuse, NY
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628 Cedar Lane
Teaneck, New Jersey 07666
2395
mi
from 98109
Teaneck, NJ
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Tucson, Arizona 85724
1219
mi
from 98109
Tucson, AZ
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Waterford, Connecticut 06385
?
mi
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Waterford, CT
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Winston-Salem, North Carolina 27104
2275
mi
from 98109
Winston-Salem, NC
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Winston-Salem, North Carolina 27157
2275
mi
from 98109
Winston-Salem, NC
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