Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)



Status:Terminated
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:Any
Updated:3/8/2019
Start Date:July 21, 2016
End Date:January 31, 2018

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A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Lampalizumab in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration Who Have Completed a Roche-Sponsored Study

This multicenter open-label extension study is designed to evaluate the safety and
tolerability of lampalizumab intravitreal injections in participants with GA secondary to
age-related macular degeneration (AMD) who completed 96 weeks of treatment in Studies GX29176
(NCT02247479) or GX29185 (NCT02247531). The extension will enroll participants from the
parent studies who received investigational lampalizumab, as well as lampalizumab-naive
participants exposed to sham comparator. All participants will receive open-label
lampalizumab in the present study.


Inclusion Criteria:

- Previous enrollment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531) with
completion of treatment and the Week 96 visit

- Agreement to remain abstinent or use a reliable form of contraception among all men
and among women of child-bearing potential

Exclusion Criteria:

- Concurrent ocular conditions that contraindicate use of lampalizumab or might affect
interpretation of study results or that might increase the risk of treatment
complications

- Concurrent disease, metabolic dysfunction, or physical or laboratory finding that
contraindicates use of lampalizumab or might affect interpretation of study results or
that might increase the risk of treatment complications

- Increased risk of infection

- Pregnancy or lactation
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123
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1445 Bush Street
San Francisco, California 94107
1339
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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...
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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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1220 New Scotland Road
Albany, New York 12208
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669 Dean Street
Albury, New South Wales 2640
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Ann Arbor, Michigan 48105
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Arlington, Texas 76012
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21 Medical Park Drive
Asheville, North Carolina 28803
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Augusta, Georgia 30909
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Aurora, Colorado 80045
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Austin, Texas 78705
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Austin, Texas 78705
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Bakersfield, California 93309
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Baltimore, Maryland 21209
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Baltimore, Maryland
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Bellevue, Washington 98004
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Beverly Hills, California 90211
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1720 7th Avenue South
Birmingham, Alabama 35233
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Bloomfield, New Jersey 07003
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800 Washington Street
Boston, Massachusetts 02111
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243 Charles Street
Boston, Massachusetts 02114
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Boston, Massachusetts 02114
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1717 Woolbright Road
Boynton Beach, Florida 33426
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6035 Fairview Road
Charlotte, North Carolina 28210
959
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22903
1051
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1606 Gunbarrel Road
Chattanooga, Tennessee 37421
728
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8 Ranoldo Terrace
Cherry Hill, New Jersey 08034
1234
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Chesterfield, Missouri 63017
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Chevy Chase, Maryland 20815
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Cincinnati, Ohio 45242
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Cleveland, Ohio 44122
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2770 North Union Boulevard
Colorado Springs, Colorado 80909
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Dallas, Texas 75231
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Detroit, Michigan 48201
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2351 Erwin Road
Durham, North Carolina 27710
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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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Fullerton, California 92835
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1432 Kimbrough Road
Germantown, Tennessee 38138
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Golden, Colorado 80401
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Grand Rapids, Michigan 49525
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200 Motor Parkway
Hauppauge, New York 11788
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Houston, Texas 77030
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10300 North Illinois Street
Indianapolis, Indiana 46290
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1116 West Ganson Street
Jackson, Michigan 49202
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La Jolla, California 92093
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9551 U.S. 78
Ladson, South Carolina 29456
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Lawrenceville, New Jersey 08648
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Lexington, Kentucky 02421
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Lexington, Kentucky 40509
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360 Merrick Road
Lynbrook, New York 11563
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Madison, Wisconsin 53792
(608) 263-2400
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Marietta, Georgia 30060
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McAllen, Texas 78503
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502 East New Haven Avenue
Melbourne, Florida 32901
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Monroeville, Pennsylvania 15146
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2485 Hospital Drive
Mountain View, California 94040
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3880 Tamiami Trail North
Naples, Florida 34103
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400 Bayonet Street
New London, Connecticut 06320
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460 Park Avenue
New York, New York 10022
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1500 Tilton Road
Northfield, New Jersey 08225
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Oakland, California 94609
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Paducah, Kentucky 42001
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Palm Beach Gardens, Florida 33410
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Palm Desert, California 92211
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Palo Alto, California 94303
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Portland, Oregon 97239
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8411 North Run Medical Drive
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4344 Central Avenue North
Saint Petersburg, Florida 33711
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400 Parnassus Avenue
San Francisco, California 94143
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