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



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:3/21/2019
Start Date:March 11, 2019
End Date:November 30, 2022
Contact:Reference Study ID Number: GR40844 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 (LUCERNE)

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
53
sites
The Woodlands, Texas 77384
971
mi
from 43215
The Woodlands, TX
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
822
mi
from 43215
Tampa, FL
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98-1079 Moanalua Road
'Aiea, Hawaii 96701
4502
mi
from 43215
'Aiea, HI
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5441 Health Center Drive
Abilene, Texas 79606
1068
mi
from 43215
Abilene, TX
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Augusta, Georgia 30909
451
mi
from 43215
Augusta, GA
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Austin, Texas 78705
1064
mi
from 43215
Austin, TX
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Austin, Texas 78705
1064
mi
from 43215
Austin, TX
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Baltimore, Maryland 21209
340
mi
from 43215
Baltimore, MD
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Boston, Massachusetts 02114
643
mi
from 43215
Boston, MA
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725 Uruguay
Buenos Aires, C1015ABO
5385
mi
from 43215
Buenos Aires,
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Burlington, Vermont 05405
590
mi
from 43215
Burlington, VT
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1606 Gunbarrel Road
Chattanooga, Tennessee 37421
361
mi
from 43215
Chattanooga, TN
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
University of Illinois at Chicago A major research university in the heart of one of...
274
mi
from 43215
Chicago, IL
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Cleveland, Ohio 44122
130
mi
from 43215
Cleveland, OH
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915 Olentangy River Road
Columbus, Ohio 43212
0
mi
from 43215
Columbus, OH
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2625 Bolton Boone Drive
DeSoto, Texas 75115
920
mi
from 43215
DeSoto, TX
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Dublin, Ohio 43016
10
mi
from 43215
Dublin, OH
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7760 France Avenue South
Edina, Minnesota 55435
624
mi
from 43215
Edina, MN
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Florence, South Carolina 29501
437
mi
from 43215
Florence, SC
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Fort Lauderdale, Florida 33334
966
mi
from 43215
Fort Lauderdale, FL
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Fort Myers, Florida 33912
932
mi
from 43215
Fort Myers, FL
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Golden, Colorado 80401
1174
mi
from 43215
Golden, CO
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2321 Ira East Woods Avenue
Grapevine, Texas 76051
919
mi
from 43215
Grapevine, TX
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Hagerstown, Maryland 21740
282
mi
from 43215
Hagerstown, MD
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Indianapolis, Indiana 46290
166
mi
from 43215
Indianapolis, IN
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Las Vegas, Nevada
1756
mi
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Las Vegas, NV
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Los Angeles, California 90333
1972
mi
from 43215
Los Angeles, CA
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Lynchburg, Virginia 24502
274
mi
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Lynchburg, VA
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Marietta, Georgia 30060
423
mi
from 43215
Marietta, GA
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Mountain View, California 94040
2097
mi
from 43215
Mountain View, CA
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1800 Republic Road
Norfolk, Virginia 23451
435
mi
from 43215
Norfolk, VA
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271
mi
from 43215
Oak Forest, IL
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Oakland, California 94609
2098
mi
from 43215
Oakland, CA
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Palm Beach Gardens, Florida 33410
920
mi
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Palm Beach Gardens, FL
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Philadelphia, Pennsylvania 19107
416
mi
from 43215
Philadelphia, PA
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Phoenix, Arizona 85020
1662
mi
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Phoenix, AZ
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1662
mi
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Phoenix, AZ
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Portland, Maine
704
mi
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Portland, ME
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Riverside, California 92505
1928
mi
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Riverside, CA
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358
mi
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Rochester, NY
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Sacramento, California 95819
2043
mi
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Sacramento, CA
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Salt Lake City, Utah
1513
mi
from 43215
Salt Lake City, UT
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Santa Ana, California 92705
1960
mi
from 43215
Santa Ana, CA
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Santa Barbara, California 93103
2038
mi
from 43215
Santa Barbara, CA
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Shirley, New York 11967
537
mi
from 43215
Shirley, NY
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9800 Levin Road Northwest
Silverdale, Washington 98383
2023
mi
from 43215
Silverdale, WA
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351
mi
from 43215
Springfield, IL
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2439 Care Drive
Tallahassee, Florida 32308
659
mi
from 43215
Tallahassee, FL
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Tampa, Florida 33609
831
mi
from 43215
Tampa, FL
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Towson, Maryland 21204
343
mi
from 43215
Towson, MD
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West Des Moines, Iowa 50266
572
mi
from 43215
West Des Moines, IA
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Wichita, Kansas 67214
783
mi
from 43215
Wichita, KS
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Willow Park, Texas 76087
999
mi
from 43215
Willow Park, TX
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