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
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...
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98-1079 Moanalua Road
'Aiea, Hawaii 96701
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5441 Health Center Drive
Abilene, Texas 79606
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Augusta, Georgia 30909
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Austin, Texas 78705
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Austin, TX
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Austin, Texas 78705
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Baltimore, Maryland 21209
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Baltimore, MD
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Boston, Massachusetts 02114
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Boston, MA
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725 Uruguay
Buenos Aires, C1015ABO
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Burlington, Vermont 05405
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1606 Gunbarrel Road
Chattanooga, Tennessee 37421
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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...
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Cleveland, Ohio 44122
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915 Olentangy River Road
Columbus, Ohio 43212
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2625 Bolton Boone Drive
DeSoto, Texas 75115
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Dublin, Ohio 43016
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7760 France Avenue South
Edina, Minnesota 55435
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Florence, South Carolina 29501
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Fort Lauderdale, Florida 33334
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Fort Myers, Florida 33912
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Golden, Colorado 80401
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2321 Ira East Woods Avenue
Grapevine, Texas 76051
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Hagerstown, Maryland 21740
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Indianapolis, Indiana 46290
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Las Vegas, Nevada
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Los Angeles, California 90333
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Lynchburg, Virginia 24502
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Marietta, Georgia 30060
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Mountain View, California 94040
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1800 Republic Road
Norfolk, Virginia 23451
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Oak Forest, IL
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Oakland, California 94609
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Palm Beach Gardens, Florida 33410
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Philadelphia, Pennsylvania 19107
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Phoenix, Arizona 85020
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Portland, Maine
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Riverside, California 92505
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Sacramento, California 95819
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Salt Lake City, Utah
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Santa Ana, California 92705
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Santa Barbara, California 93103
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Shirley, New York 11967
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9800 Levin Road Northwest
Silverdale, Washington 98383
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Springfield, IL
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2439 Care Drive
Tallahassee, Florida 32308
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Tampa, Florida 33609
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The Woodlands, Texas 77384
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Towson, Maryland 21204
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West Des Moines, Iowa 50266
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Wichita, Kansas 67214
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Willow Park, Texas 76087
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