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)

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 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
6035 Fairview Road
Charlotte, North Carolina 28210
?
mi
from
Charlotte, NC
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
Bakersfield, California 93309
?
mi
from
Bakersfield, CA
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
Bloomfield, New Jersey 07003
?
mi
from
Bloomfield, NJ
Click here to add this to my saved trials
Boston, Massachusetts 02111
?
mi
from
Boston, MA
Click here to add this to my saved trials
Calgary, Alberta
?
mi
from
Calgary,
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
8 Ranoldo Terrace
Cherry Hill, New Jersey 08034
?
mi
from
Cherry Hill, NJ
Click here to add this to my saved trials
1815 Clarkson Road
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
2770 North Union Boulevard
Colorado Springs, Colorado 80909
?
mi
from
Colorado Springs, CO
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
?
mi
from
Edison, NJ
Click here to add this to my saved trials
Encino, California 91436
?
mi
from
Encino, CA
Click here to add this to my saved trials
1224 Graham Road
Florissant, Missouri 63031
?
mi
from
Florissant, MO
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
Grand Rapids, Michigan 45946
?
mi
from
Grand Rapids, MI
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
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
9415 Campus Point Drive
La Jolla, California 92093
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
9551 U.S. 78
Ladson, South Carolina 29456
?
mi
from
Ladson, SC
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 90033
?
mi
from
Los Angeles, CA
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
502 East New Haven Avenue
Melbourne, Florida 32901
?
mi
from
Melbourne, FL
Click here to add this to my saved trials
Nashville, Tennessee 37203
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Palm Beach Gardens, Florida 33418
?
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
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
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85014
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Plantation, Florida 33324
?
mi
from
Plantation, FL
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
160 Sawgrass Drive
Rochester, New York 14620
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Rockville Centre, New York 11570
?
mi
from
Rockville Centre, NY
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
4344 Central Avenue North
Saint Petersburg, Florida 33711
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
Salt Lake City, Utah 84107
?
mi
from
Salt Lake City, UT
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
SLingerlands, New York 12159
?
mi
from
SLingerlands, 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
601 Maple Drive
Springdale, Arkansas 72764
?
mi
from
Springdale, AR
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
628 Cedar Lane
Teaneck, New Jersey 07666
?
mi
from
Teaneck, NJ
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
Waterford, Connecticut 06385
?
mi
from
Waterford, CT
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