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
Lynchburg, Virginia 24502
1019
mi
from
Lynchburg, VA
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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...
1113
mi
from
Tampa, FL
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98-1079 Moanalua Road
'Aiea, Hawaii 96701
3719
mi
from
'Aiea, HI
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5441 Health Center Drive
Abilene, Texas 79606
384
mi
from
Abilene, TX
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Augusta, Georgia 30909
936
mi
from
Augusta, GA
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Austin, Texas 78705
515
mi
from
Austin, TX
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Austin, Texas 78705
515
mi
from
Austin, TX
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Baltimore, Maryland 21209
1145
mi
from
Baltimore, MD
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Boston, Massachusetts 02114
1444
mi
from
Boston, MA
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725 Uruguay
Buenos Aires, C1015ABO
5601
mi
from
Buenos Aires,
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Burlington, Vermont 05405
1356
mi
from
Burlington, VT
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1606 Gunbarrel Road
Chattanooga, Tennessee 37421
728
mi
from
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...
610
mi
from
Chicago, IL
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Cleveland, Ohio 44122
903
mi
from
Cleveland, OH
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915 Olentangy River Road
Columbus, Ohio 43212
809
mi
from
Columbus, OH
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2625 Bolton Boone Drive
DeSoto, Texas 75115
356
mi
from
DeSoto, TX
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Dublin, Ohio 43016
804
mi
from
Dublin, OH
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7760 France Avenue South
Edina, Minnesota 55435
543
mi
from
Edina, MN
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Florence, South Carolina 29501
1037
mi
from
Florence, SC
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Fort Lauderdale, Florida 33334
1305
mi
from
Fort Lauderdale, FL
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Fort Myers, Florida 33912
1213
mi
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Fort Myers, FL
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Golden, Colorado 80401
422
mi
from
Golden, CO
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2321 Ira East Woods Avenue
Grapevine, Texas 76051
335
mi
from
Grapevine, TX
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Hagerstown, Maryland 21740
1089
mi
from
Hagerstown, MD
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Indianapolis, Indiana 46290
644
mi
from
Indianapolis, IN
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Las Vegas, Nevada
960
mi
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Las Vegas, NV
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Los Angeles, California 90333
1168
mi
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Los Angeles, CA
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Marietta, Georgia 30060
787
mi
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Marietta, GA
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Mountain View, California 94040
1325
mi
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Mountain View, CA
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1800 Republic Road
Norfolk, Virginia 23451
1196
mi
from
Norfolk, VA
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597
mi
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Oak Forest, IL
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Oakland, California 94609
1330
mi
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Oakland, CA
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Palm Beach Gardens, Florida 33410
1276
mi
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Palm Beach Gardens, FL
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Philadelphia, Pennsylvania 19107
1225
mi
from
Philadelphia, PA
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Phoenix, Arizona 85020
853
mi
from
Phoenix, AZ
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852
mi
from
Phoenix, AZ
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Portland, Maine
1492
mi
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Portland, ME
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Riverside, California 92505
1122
mi
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Riverside, CA
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1121
mi
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Rochester, NY
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Sacramento, California 95819
1283
mi
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Sacramento, CA
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Salt Lake City, Utah
779
mi
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Salt Lake City, UT
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Santa Ana, California 92705
1155
mi
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Santa Ana, CA
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Santa Barbara, California 93103
1238
mi
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Santa Barbara, CA
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Shirley, New York 11967
1346
mi
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Shirley, NY
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9800 Levin Road Northwest
Silverdale, Washington 98383
1426
mi
from
Silverdale, WA
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462
mi
from
Springfield, IL
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2439 Care Drive
Tallahassee, Florida 32308
924
mi
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Tallahassee, FL
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Tampa, Florida 33609
1115
mi
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Tampa, FL
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The Woodlands, Texas 77384
535
mi
from
The Woodlands, TX
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Towson, Maryland 21204
1148
mi
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Towson, MD
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West Des Moines, Iowa 50266
340
mi
from
West Des Moines, IA
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Wichita, Kansas 67214
28
mi
from
Wichita, KS
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Willow Park, Texas 76087
574
mi
from
Willow Park, TX
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