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 Investigational Site
Austin, Texas 78759
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Novartis Investigative Site
Abilene, Texas 79606
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Abilene, TX
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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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Altamonte Springs, FL
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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
Baltimore, Maryland 21287
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Baltimore, MD
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Novartis Investigative Site
Bloomington, Illinois 61701
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Bloomington, IL
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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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Colorado Springs, CO
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Novartis Investigative Site
Deerfield Beach, Florida 33064
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Deerfield Beach, FL
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Novartis Investigative Site
Dublin, Ohio 43016
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Dublin, OH
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Novartis Investigative Site
Fairfield, Ohio 45014
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Fairfield, OH
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Novartis Investigative Site
Fort Myers, Florida 33912
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Fort Myers, FL
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Novartis Investigative Site
Fort Worth, Texas 76104
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Fort Worth, TX
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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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Novartis Investigative Site
Huntington Beach, California 92647
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Huntington Beach, CA
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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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Novartis Investigative Site
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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Novartis Investigator Site
Milwaukee, Wisconsin 53209
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Milwaukee, WI
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Novartis Investigative Site
Morgantown, West Virginia 26506
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Morgantown, WV
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Novartis Investigative Site
Mountain View, California 94040
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Mountain View, CA
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Novartis Investigative Site
Nashville, Tennessee 37205
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Nashville, TN
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Novartis Investigative Site
New London, Connecticut 06320
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New London, CT
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Novartis Investigative Site
Oakland, California 94612
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Oakland, CA
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Novartis Investigative Site
Ocala, Florida 34471
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Ocala, FL
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Novartis Investigative Site
Palm Beach Gardens, Florida 33410
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Palm Beach Gardens, FL
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Novartis Investigative Site
Pensacola, Florida 32504
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Pensacola, FL
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Novartis Investigative Site
Peoria, Arizona 85381
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Peoria, AZ
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Novartis Investigative Site
Phoenix, Arizona 85012
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Phoenix, AZ
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Novartis Investigative Site
Plano, Texas 75024
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Plano, TX
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Novartis Investigative Site
Portland, Maine 04102
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Portland, ME
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Novartis Investigative Site
Redlands, California 92374
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Redlands, CA
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Novartis Investigative Site
Reno, Nevada 89502
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Reno, NV
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Novartis Investigative Site
Richmond, Virginia 23249
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Richmond, VA
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Novartis Investigative Site
Rochester, New York 14615
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Rochester, NY
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Novartis Investigative Site
Sacramento, California 95825
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Sacramento, CA
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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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San Antonio, TX
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Novartis Investigative Site
Sarasota, Florida 34239
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Sarasota, FL
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Novartis Investigative Site
Shawnee Mission, Kansas 66204
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Shawnee Mission, KS
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Novartis Investigative Site
Shirley, New York 11967
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Shirley, NY
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Novartis Investigative Site
Silverdale, Washington 98383
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Silverdale, WA
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Novartis Investigative Site
Southern Pines, North Carolina 28387
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Southern Pines, NC
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Novartis Investigative Site
Spokane, Washington 99202
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Spokane, WA
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Novartis Investigative Site
Syracuse, New York 13210
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Syracuse, NY
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Novartis Investigative Site
Tallahassee, Florida 32308
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Novartis Investigative Site
Toms River, New Jersey 08755
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Toms River, NJ
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Novartis Investigative Site
University Place, Washington 98467
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University Place, WA
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Novartis Investigative Site
Vero Beach, Florida 32960
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Novartis Investigative Site
Waldorf, Maryland 20602
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Waldorf, MD
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Novartis Investigative Site
Warrenton, Virginia 20186
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Warrenton, VA
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Novartis Investigative Site
Winter Haven, Florida 33880
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Winter Haven, FL
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