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
Plantation, Florida 33324
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Asheville, North Carolina 28803
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Bakersfield, California 93309
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600 North Wolfe Street
Baltimore, Maryland 21287
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Baltimore, MD
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Bloomfield, New Jersey 07003
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Boston, Massachusetts 02111
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Boston, MA
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Calgary, Alberta
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Calgary,
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Campbell, California 95008
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Campbell, CA
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6035 Fairview Road
Charlotte, North Carolina 28210
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Charlotte, NC
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8 Ranoldo Terrace
Cherry Hill, New Jersey 08034
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Cherry Hill, NJ
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1815 Clarkson Road
Chesterfield, Missouri 63017
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Chevy Chase, Maryland 20815
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Chevy Chase, MD
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Chicago, IL
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Cincinnati, Ohio 45242
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Cincinnati, OH
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2770 North Union Boulevard
Colorado Springs, Colorado 80909
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Colorado Springs, CO
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Dallas, Texas 75231
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Dallas, TX
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5 West Sample Road
Deerfield Beach, Florida 33064
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Deerfield Beach, FL
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Edison, NJ
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Encino, California 91436
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Encino, CA
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1224 Graham Road
Florissant, Missouri 63031
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Florissant, MO
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1432 Kimbrough Road
Germantown, Tennessee 38138
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Germantown, TN
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Grand Rapids, Michigan 45946
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Grand Rapids, MI
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200 Motor Parkway
Hauppauge, New York 11788
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Hauppauge, NY
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Houston, Texas 77025
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Houston, TX
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Houston, Texas 77030
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Houston, TX
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9415 Campus Point Drive
La Jolla, California 92093
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La Jolla, CA
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9551 U.S. 78
Ladson, South Carolina 29456
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Lexington, Kentucky 40509
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Lexington, KY
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Los Angeles, California 90033
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Los Angeles, CA
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McAllen, Texas 78503
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McAllen, TX
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502 East New Haven Avenue
Melbourne, Florida 32901
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Melbourne, FL
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Nashville, Tennessee 37203
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Nashville, TN
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Palm Beach Gardens, Florida 33418
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36949 Cook Street
Palm Desert, California 92211
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Palm Desert, CA
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Pasadena, California 91107
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Pasadena, CA
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Pensacola, Florida 32503
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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Phoenix, Arizona 85014
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Portland, Oregon 97210
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Poway, California 92064
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Rapid City, South Dakota 57701
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Redlands, California 92374
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Reno, Nevada 89502
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Reno, NV
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160 Sawgrass Drive
Rochester, New York 14620
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Rochester, NY
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Rockville Centre, New York 11570
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Rockville Centre, NY
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Sacramento, California 95817
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4344 Central Avenue North
Saint Petersburg, Florida 33711
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Saint Petersburg, FL
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Salt Lake City, Utah 84107
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Salt Lake City, UT
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Shawnee Mission, Kansas 66204
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SLingerlands, New York 12159
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Southern Pines, North Carolina 28387
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Spokane, Washington 99204
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Spokane, WA
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601 Maple Drive
Springdale, Arkansas 72764
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Sun City, Arizona 85351
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3107 East Genesee Street
Syracuse, New York 13224
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Syracuse, NY
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628 Cedar Lane
Teaneck, New Jersey 07666
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Tucson, Arizona 85724
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Waterford, Connecticut 06385
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Winston-Salem, North Carolina 27104
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Winston-Salem, North Carolina 27157
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