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
2625 Bolton Boone Drive
DeSoto, Texas 75115
1221
mi
from 91732
DeSoto, 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...
2135
mi
from 91732
Tampa, FL
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98-1079 Moanalua Road
'Aiea, Hawaii 96701
2575
mi
from 91732
'Aiea, HI
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5441 Health Center Drive
Abilene, Texas 79606
1057
mi
from 91732
Abilene, TX
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Augusta, Georgia 30909
2059
mi
from 91732
Augusta, GA
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Austin, Texas 78705
1211
mi
from 91732
Austin, TX
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Austin, Texas 78705
1211
mi
from 91732
Austin, TX
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Baltimore, Maryland 21209
2298
mi
from 91732
Baltimore, MD
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Boston, Massachusetts 02114
2578
mi
from 91732
Boston, MA
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725 Uruguay
Buenos Aires, C1015ABO
6112
mi
from 91732
Buenos Aires,
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Burlington, Vermont 05405
2467
mi
from 91732
Burlington, VT
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1606 Gunbarrel Road
Chattanooga, Tennessee 37421
1862
mi
from 91732
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...
1729
mi
from 91732
Chicago, IL
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Cleveland, Ohio 44122
2041
mi
from 91732
Cleveland, OH
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915 Olentangy River Road
Columbus, Ohio 43212
1959
mi
from 91732
Columbus, OH
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Dublin, Ohio 43016
1953
mi
from 91732
Dublin, OH
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7760 France Avenue South
Edina, Minnesota 55435
1504
mi
from 91732
Edina, MN
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Florence, South Carolina 29501
2174
mi
from 91732
Florence, SC
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Fort Lauderdale, Florida 33334
2314
mi
from 91732
Fort Lauderdale, FL
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Fort Myers, Florida 33912
2209
mi
from 91732
Fort Myers, FL
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Golden, Colorado 80401
807
mi
from 91732
Golden, CO
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2321 Ira East Woods Avenue
Grapevine, Texas 76051
1205
mi
from 91732
Grapevine, TX
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Hagerstown, Maryland 21740
2241
mi
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Hagerstown, MD
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Indianapolis, Indiana 46290
1793
mi
from 91732
Indianapolis, IN
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Las Vegas, Nevada
217
mi
from 91732
Las Vegas, NV
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Los Angeles, California 90333
13
mi
from 91732
Los Angeles, CA
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Lynchburg, Virginia 24502
2175
mi
from 91732
Lynchburg, VA
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Marietta, Georgia 30060
1907
mi
from 91732
Marietta, GA
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Mountain View, California 94040
323
mi
from 91732
Mountain View, CA
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1800 Republic Road
Norfolk, Virginia 23451
2351
mi
from 91732
Norfolk, VA
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1721
mi
from 91732
Oak Forest, IL
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Oakland, California 94609
352
mi
from 91732
Oakland, CA
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Palm Beach Gardens, Florida 33410
2299
mi
from 91732
Palm Beach Gardens, FL
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Philadelphia, Pennsylvania 19107
2375
mi
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Philadelphia, PA
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Phoenix, Arizona 85020
343
mi
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Phoenix, AZ
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343
mi
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Phoenix, AZ
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Portland, Maine
2614
mi
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Portland, ME
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Riverside, California 92505
37
mi
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Riverside, CA
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2242
mi
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Rochester, NY
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Sacramento, California 95819
366
mi
from 91732
Sacramento, CA
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Salt Lake City, Utah
570
mi
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Salt Lake City, UT
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Santa Ana, California 92705
23
mi
from 91732
Santa Ana, CA
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Santa Barbara, California 93103
98
mi
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Santa Barbara, CA
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Shirley, New York 11967
2491
mi
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Shirley, NY
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9800 Levin Road Northwest
Silverdale, Washington 98383
968
mi
from 91732
Silverdale, WA
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1608
mi
from 91732
Springfield, IL
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2439 Care Drive
Tallahassee, Florida 32308
1979
mi
from 91732
Tallahassee, FL
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Tampa, Florida 33609
2133
mi
from 91732
Tampa, FL
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The Woodlands, Texas 77384
1340
mi
from 91732
The Woodlands, TX
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Towson, Maryland 21204
2301
mi
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Towson, MD
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West Des Moines, Iowa 50266
1415
mi
from 91732
West Des Moines, IA
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Wichita, Kansas 67214
1183
mi
from 91732
Wichita, KS
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Willow Park, Texas 76087
1355
mi
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Willow Park, TX
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