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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Trial Summary
Trial Overview
Inclusion Criteria

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
We found this trial at
123
sites
Maine Eye Center
Portland, Maine
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University of South Florida
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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Retina Consultants of Hawaii
98-1079 Moanalua Road
'Aiea, Hawaii 96701
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'Aiea, HI
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Retina Res Institute of Texas
5441 Health Center Drive
Abilene, Texas 79606
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Abilene, TX
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Lions Eye Institute
1220 New Scotland Road
Albany, New York 12208
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Albany, NY
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Eyeclinic Albury Wodonga
669 Dean Street
Albury, New South Wales 2640
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Albury,
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University of Michigan/Kellogg Eye Center
Ann Arbor, Michigan 48105
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Texas Retina Associates
Arlington, Texas 76012
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Arlington, TX
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West Carolina Retinal AssocPA
21 Medical Park Drive
Asheville, North Carolina 28803
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Asheville, NC
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Retina and Vitreous Center of Southern Oregon, PC
Ashland, Oregon 97520
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Ashland, OR
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Southeast Retina Center, P.C.
Augusta, Georgia 30909
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Augusta, GA
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University of Colorado
Aurora, Colorado 80045
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Austin Retina Associates
Austin, Texas 78705
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Austin, TX
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Retina Research Center
Austin, Texas 78705
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California Retina Consultants
Bakersfield, California 93309
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Bakersfield, CA
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The Retina Care Center
Baltimore, Maryland 21209
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Wilmer Eye Institute
Baltimore, Maryland
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Vitreoretinal Associates of Washington
Bellevue, Washington 98004
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Bellevue, WA
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Retina-Vitreous Associates Medical Group
Beverly Hills, California 90211
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Uni of Alabama At Birmingham Clinical Research Unit
1720 7th Avenue South
Birmingham, Alabama 35233
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Birmingham, AL
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Retina Center of New Jersey, LLC
Bloomfield, New Jersey 07003
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Bloomfield, NJ
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Tufts Medical Center Research
800 Washington Street
Boston, Massachusetts 02111
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Boston, MA
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Mass Eye and Ear Infirmary
243 Charles Street
Boston, Massachusetts 02114
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Boston, MA
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Ophthalmic Consultants of Boston
Boston, Massachusetts 02114
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Boston, MA
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Florida Eye Microsurgical Inst
1717 Woolbright Road
Boynton Beach, Florida 33426
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Char Eye Ear &Throat Assoc
6035 Fairview Road
Charlotte, North Carolina 28210
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Charlotte, NC
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Univ of Virginia Ophthalmology
1300 Jefferson Park Avenue
Charlottesville, Virginia 22903
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Charlottesville, VA
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Southeastern Retina Associates Chattanooga
1606 Gunbarrel Road
Chattanooga, Tennessee 37421
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Chattanooga, TN
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Mid Atlantic Retina - Wills Eye Hospital
8 Ranoldo Terrace
Cherry Hill, New Jersey 08034
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Cherry Hill, NJ
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Lifelong Vision Foundation
Chesterfield, Missouri 63017
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Chesterfield, MO
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Retina Group of Washington
Chevy Chase, Maryland 20815
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Cincinnati Eye Institute
Cincinnati, Ohio 45242
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Retina Assoc. of Cleveland
Cleveland, Ohio 44122
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Cleveland Clinic Foundation; Cole Eye Institute
Cleveland, Ohio 44195
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Retina Consultants of Southern
2770 North Union Boulevard
Colorado Springs, Colorado 80909
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OSU Eye Physicians and Surgeons, LLC.
Columbus, Ohio 43212
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Columbus, OH
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Texas Retina Associates
Dallas, Texas 75231
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Kresge Eye Institute
Detroit, Michigan 48201
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Detroit, MI
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Duke University Eye Center; Vitreoretinal
2351 Erwin Road
Durham, North Carolina 27710
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Durham, NC
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Vitreoretinal Surgery
7760 France Avenue South
Edina, Minnesota 55435
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Edina, MN
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New Jersey Retina Research Foundation
Edison, New Jersey
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Edison, NJ
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Palmetto Retina Center, LLC
Florence, South Carolina 29501
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Florence, SC
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Retina Group of Florida
Fort Lauderdale, Florida 33334
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Retina Health Center
Fort Myers, Florida 33907
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National Ophthalmic Research Institute
Fort Myers, Florida 33912
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Retina Consultants of Orange County
Fullerton, California 92835
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Fullerton, CA
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Charles Retina Institution
1432 Kimbrough Road
Germantown, Tennessee 38138
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Germantown, TN
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Colorado Retina Associates
Golden, Colorado 80401
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Golden, CO
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Vitreo-Retinal Associates
Grand Rapids, Michigan 49525
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Grand Rapids, MI
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Long Is. Vitreoretinal Consult
200 Motor Parkway
Hauppauge, New York 11788
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Hauppauge, NY
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Retina Consultants of Houston
Houston, Texas 77030
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Midwest Eye Institute Northside
10300 North Illinois Street
Indianapolis, Indiana 46290
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Indianapolis, IN
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Specialty Eye Institute
1116 West Ganson Street
Jackson, Michigan 49202
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Jackson, MI
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UCSD Shiley Eye Center
La Jolla, California 92093
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Charleston Neuroscience Inst
9551 U.S. 78
Ladson, South Carolina 29456
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Retina Consultants of Nevada
Las Vegas, Nevada
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Delaware Valley Retina Assoc
4 Princess Road
Lawrenceville, New Jersey 08648
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Lawrenceville, NJ
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Lahey Clinic Med Ctr
16 Hayden Avenue
Lexington, Kentucky 02421
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Lexington, KY
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Retina Associates of Kentucky
Lexington, Kentucky 40509
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Jules Stein Eye Institute, UCLA
Los Angeles, California
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Opthalmic Consultants of LI
360 Merrick Road
Lynbrook, New York 11563
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University of Wisconsin
Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Georgia Retina, P.C.
Marietta, Georgia 30060
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Marietta, GA
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Valley Retina Institute, P.A.
McAllen, Texas 78503
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McAllen, TX
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Florida Eye Associates
502 East New Haven Avenue
Melbourne, Florida 32901
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Retina Vitreous Consultants
Monroeville, Pennsylvania 15146
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West Virginia University Eye Institute
Morgantown, West Virginia 26506
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N CA Retina Vitreous Assoc
2485 Hospital Drive
Mountain View, California 94040
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Bascom Palmer Eye Institute
3880 Tamiami Trail North
Naples, Florida 34103
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Tennessee Retina, P.C.
Nashville, Tennessee 37203
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Retina Group of New England
400 Bayonet Street
New London, Connecticut 06320
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New York Eye & Ear Infirmary
New York, New York
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Vitreous-Retina-Macula
460 Park Avenue
New York, New York 10022
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Retinal & Ophthalmic Cons PC
1500 Tilton Road
Northfield, New Jersey 08225
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East Bay Retina Consultants, Inc.
Oakland, California 94609
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Paducah Retinal Center
Paducah, Kentucky 42001
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Retina Care Specialists
Palm Beach Gardens, Florida 33410
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Bascom Palmer Eye Institute
Palm Beach Gardens, Florida 33418
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Southern CA Desert Retina Cons
36949 Cook Street
Palm Desert, California 92211
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Byers Eye Insitute at Stanford
2452 Watson Court
Palo Alto, California 94303
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Retina Specialty Institute
Pensacola, Florida 32503
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Mid-Atlantic Retina
Philadelphia, Pennsylvania 19107
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Retinal Research Institute LLC
Phoenix, Arizona 85014
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Associated Retina Consultants
Phoenix, Arizona 85020
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Fort Lauderdale Eye Institute
Plantation, Florida 33324
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Retina Northwest, PC
Portland, Oregon 97210
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Portland, OR
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Oregon HSU; Casey Eye Institute
3303 Southwest Bond Avenue
Portland, Oregon 97239
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Retina Consultants, San Diego
Poway, California 92064
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Black Hills Eye Institute
Rapid City, South Dakota 57701
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Sierra Eye Associates
Reno, Nevada 89502
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Reno, NV
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Eye Surgeons of Richmond Inc. dba Virginia Eye Institute
8411 North Run Medical Drive
Richmond, Virginia 23226
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Richmond, VA
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Retina Institute of Virginia
Richmond, Virginia
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Retina Assoc of Western NY
160 Sawgrass Drive
Rochester, New York 14620
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Assoc Retinal Consultants PC
Royal Oak, Michigan 48073
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University of California Davis Eye Center
Sacramento, California 95817
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Sacramento, CA
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Retinal Consultants Medical Group, Inc.
Sacramento, California 95819
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Retina Vitreous Assoc of FL
4344 Central Avenue North
Saint Petersburg, Florida 33711
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Retina Associates of Utah
Salt Lake City, Utah
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W Coast Retina Med Group Inc
1445 Bush Street
San Francisco, California 94107
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UCSF Comprehensive Cancer Ctr; Ophthalmology
400 Parnassus Avenue
San Francisco, California 94143
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Orange County Retina Medical Group
Santa Ana, California 92705
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