Study of Safety and Efficacy of Brolucizumab 6 mg Drug Product Intended for Commercialization in Patients With nAMD



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:2/20/2019
Start Date:January 15, 2018
End Date:September 6, 2018

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Trial Summary
Trial Overview
Inclusion Criteria

A 24-week, Double-masked, Multicenter, Two-arm Extension Study to Collect Safety and Efficacy Data on Brolucizumab 6 mg Drug Product Intended for Commercialization in Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2301 Study

The purpose of this study is to collect data on safety and efficacy of the brolucizumab 6 mg
drug product intended for commercialization in patients with neovascular age-related macular
degeneration (nAMD) and to support comparability to the 6 mg drug product used in Phase III.


Inclusion Criteria:

- Sign written informed consent

- Completed the core study, CRTH258A2301

Exclusion Criteria:

- Patient discontinued the treatment or the core study prematurely at any time

- Patient received standard of care treatment for nAMD after completion of the core
study

- Pregnant or nursing women and women of child-bearing potential

- Other protocol-specified exclusion criteria may apply
We found this trial at
60
sites
Novartis
San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Novartis Investigative Site
Abilene, Texas 79606
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Novartis Investigator Site
Albuquerque, New Mexico 87108
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Albuquerque, NM
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Novartis Investigative Site
Altamonte Springs, Florida 32701
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Novartis Investigative Site
Arcadia, California 91006
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Arcadia, CA
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Novartis Investigative Site
Arecibo, 00612
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Arecibo,
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Novartis Investigational Site
Austin, Texas 78759
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Austin, TX
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Novartis
Baltimore, Maryland 21287
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Novartis Investigative Site
Bloomington, Illinois 61701
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Novartis Investigative Site
Boise, Idaho 83712
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Boise, ID
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Novartis Investigative Site
Bridgeport, Connecticut 06606
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Bridgeport, CT
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Novartis Investigative Site
Camp Hill, Pennsylvania 17011
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Camp Hill, PA
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Novartis Investigative Site
Charlotte, North Carolina 28277
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Charlotte, NC
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Novartis Investigative Site
Cleveland, Ohio 44109
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Cleveland, OH
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Novartis Investigative Site
Colorado Springs, Colorado 80907
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Novartis Investigative Site
Deerfield Beach, Florida 33064
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Novartis Investigative Site
Dublin, Ohio 43016
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Novartis Investigative Site
Fairfield, Ohio 45014
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Novartis Investigative Site
Fort Myers, Florida 33912
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Novartis Investigative Site
Fort Worth, Texas 76104
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Novartis Investigative Site
Golden, Colorado 80401
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Golden, CO
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Novartis Investigative Site
Houston, Texas 77030
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Houston, TX
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Huntington Beach, California 92647
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Novartis Investigative Site
Indianapolis, Indiana 46202
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Indianapolis, IN
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Novartis Investigative Site
La Jolla, California 92037
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La Jolla, CA
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Novartis Investigative Site
Las Vegas, Nevada 89135
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Las Vegas, NV
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Leawood, Kansas 66211
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Leawood, KS
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Novartis Investigative Site
Loma Linda, California 92354
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Loma Linda, CA
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Milwaukee, Wisconsin 53209
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Milwaukee, WI
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Morgantown, West Virginia 26506
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Mountain View, California 94040
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Nashville, Tennessee 37205
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New London, Connecticut 06320
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New London, CT
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Oakland, California 94612
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Ocala, Florida 34471
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Palm Beach Gardens, Florida 33410
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Pensacola, Florida 32504
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Peoria, Arizona 85381
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Phoenix, Arizona 85012
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Plano, Texas 75024
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Portland, Maine 04102
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Redlands, California 92374
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Reno, Nevada 89502
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Richmond, Virginia 23249
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Rochester, New York 14615
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Sacramento, California 95825
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Sarasota, Florida 34239
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Shawnee Mission, Kansas 66204
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Shirley, New York 11967
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Silverdale, Washington 98383
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Southern Pines, North Carolina 28387
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Spokane, Washington 99202
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Syracuse, New York 13210
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Tallahassee, Florida 32308
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Toms River, New Jersey 08755
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University Place, Washington 98467
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Vero Beach, Florida 32960
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Waldorf, Maryland 20602
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Warrenton, Virginia 20186
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Novartis Investigative Site
Winter Haven, Florida 33880
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