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
2770 North Union Boulevard
Colorado Springs, Colorado 80909
1771
mi
from 02139
Colorado Springs, CO
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Asheville, North Carolina 28803
771
mi
from 02139
Asheville, NC
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Bakersfield, California 93309
2590
mi
from 02139
Bakersfield, CA
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600 North Wolfe Street
Baltimore, Maryland 21287
356
mi
from 02139
Baltimore, MD
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Bloomfield, New Jersey 07003
192
mi
from 02139
Bloomfield, NJ
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Boston, Massachusetts 02111
2
mi
from 02139
Boston, MA
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Calgary, Alberta
?
mi
from 02139
Calgary,
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Campbell, California 95008
2680
mi
from 02139
Campbell, CA
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6035 Fairview Road
Charlotte, North Carolina 28210
722
mi
from 02139
Charlotte, NC
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8 Ranoldo Terrace
Cherry Hill, New Jersey 08034
263
mi
from 02139
Cherry Hill, NJ
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1815 Clarkson Road
Chesterfield, Missouri 63017
1052
mi
from 02139
Chesterfield, MO
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Chevy Chase, Maryland 20815
390
mi
from 02139
Chevy Chase, MD
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845
mi
from 02139
Chicago, IL
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Cincinnati, Ohio 45242
735
mi
from 02139
Cincinnati, OH
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Dallas, Texas 75231
1540
mi
from 02139
Dallas, TX
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5 West Sample Road
Deerfield Beach, Florida 33064
1223
mi
from 02139
Deerfield Beach, FL
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213
mi
from 02139
Edison, NJ
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Encino, California 91436
2597
mi
from 02139
Encino, CA
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1224 Graham Road
Florissant, Missouri 63031
1036
mi
from 02139
Florissant, MO
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1432 Kimbrough Road
Germantown, Tennessee 38138
1121
mi
from 02139
Germantown, TN
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Grand Rapids, Michigan 45946
740
mi
from 02139
Grand Rapids, MI
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200 Motor Parkway
Hauppauge, New York 11788
154
mi
from 02139
Hauppauge, NY
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Houston, Texas 77025
1601
mi
from 02139
Houston, TX
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Houston, Texas 77030
1606
mi
from 02139
Houston, TX
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9415 Campus Point Drive
La Jolla, California 92093
2574
mi
from 02139
La Jolla, CA
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9551 U.S. 78
Ladson, South Carolina 29456
812
mi
from 02139
Ladson, SC
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Lexington, Kentucky 40509
763
mi
from 02139
Lexington, KY
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Los Angeles, California 90033
2588
mi
from 02139
Los Angeles, CA
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McAllen, Texas 78503
1895
mi
from 02139
McAllen, TX
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502 East New Haven Avenue
Melbourne, Florida 32901
1121
mi
from 02139
Melbourne, FL
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Nashville, Tennessee 37203
940
mi
from 02139
Nashville, TN
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Palm Beach Gardens, Florida 33418
1188
mi
from 02139
Palm Beach Gardens, FL
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36949 Cook Street
Palm Desert, California 92211
2500
mi
from 02139
Palm Desert, CA
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Pasadena, California 91107
2580
mi
from 02139
Pasadena, CA
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Pensacola, Florida 32503
1214
mi
from 02139
Pensacola, FL
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Philadelphia, Pennsylvania 19104
270
mi
from 02139
Philadelphia, PA
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Phoenix, Arizona 85014
2290
mi
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Phoenix, AZ
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Plantation, Florida 33324
1235
mi
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Plantation, FL
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Portland, Oregon 97210
2530
mi
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Portland, OR
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Poway, California 92064
2561
mi
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Poway, CA
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Rapid City, South Dakota 57701
1610
mi
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Rapid City, SD
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Redlands, California 92374
2532
mi
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Redlands, CA
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Reno, Nevada 89502
2511
mi
from 02139
Reno, NV
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160 Sawgrass Drive
Rochester, New York 14620
334
mi
from 02139
Rochester, NY
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Rockville Centre, New York 11570
174
mi
from 02139
Rockville Centre, NY
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Sacramento, California 95817
2621
mi
from 02139
Sacramento, CA
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4344 Central Avenue North
Saint Petersburg, Florida 33711
1199
mi
from 02139
Saint Petersburg, FL
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Salt Lake City, Utah 84107
2092
mi
from 02139
Salt Lake City, UT
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Shawnee Mission, Kansas 66204
1252
mi
from 02139
Shawnee Mission, KS
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SLingerlands, New York 12159
142
mi
from 02139
SLingerlands, NY
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Southern Pines, North Carolina 28387
667
mi
from 02139
Southern Pines, NC
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Spokane, Washington 99204
2256
mi
from 02139
Spokane, WA
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601 Maple Drive
Springdale, Arkansas 72764
1299
mi
from 02139
Springdale, AR
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Sun City, Arizona 85351
2298
mi
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Sun City, AZ
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3107 East Genesee Street
Syracuse, New York 13224
257
mi
from 02139
Syracuse, NY
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628 Cedar Lane
Teaneck, New Jersey 07666
182
mi
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Teaneck, NJ
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Tucson, Arizona 85724
2275
mi
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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
652
mi
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Winston-Salem, NC
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Winston-Salem, North Carolina 27157
652
mi
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Winston-Salem, NC
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