An Extension Study to Evaluate the Long-Term Safety of Lampalizumab in Participants With Geographic Atrophy



Status:Terminated
Healthy:No
Age Range:60 - 89
Updated:2/23/2019
Start Date:May 29, 2012
End Date:February 9, 2018

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A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Lampalizumab (FCFD4514S) in Patients With Geographic Atrophy Who Have Completed Genentech-Sponsored Lampalizumab Studies

This is a multicenter, open-label extension study of safety and tolerability of lampalizumab
administered by intravitreal (ITV) injection to participants with geographic atrophy (GA) who
have completed the 18-month treatment in Study CFD4870g (GX01456) (NCT01229215) or 24-week
treatment in Study GX29455 (NCT02288559).


Inclusion Criteria:

- For CFD4870g participants: Previous enrollment and completion (Month 18 visit) of
Study CFD4870g without early treatment discontinuation (lampalizumab or sham)

- For GX29455 participants: Previous enrollment and completion (Week 24 visit) of Study
GX29455 without early treatment discontinuation (lampalizumab or sham)

- Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit
quality fundus imaging

Exclusion Criteria:

- Early treatment and/or study discontinuation prior to completion of study CFD4870g
(GX01456) and GX29455

- Vitrectomy surgery, submacular surgery, or other surgical intervention for age-related
macular degeneration (AMD) in the study eye

- Subfoveal focal laser photocoagulation in the study eye

- Treatment with Visodyne, external-beam radiation therapy, or transpupillary
thermotherapy in the study eye

- Intravitreally (ITV) drug delivery (e.g., ITV corticosteroid injection,
anti-angiogenic drugs, anticomplement drugs, or device implantation) in the study eye.
Lampalizumab in study eye and ranibizumab in either eye are permitted

- Any concurrent ocular or intraocular condition in the study eye that contraindicates
the use of an investigational drug or may affect interpretation of the study results
or may render the participant at high risk for treatment complications
We found this trial at
42
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5441 Health Center Drive
Abilene, Texas 79606
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Albuquerque, New Mexico 87109
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21 Medical Park Drive
Asheville, North Carolina 28803
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Augusta, Georgia 30909
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Austin, Texas 78705
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Baltimore, Maryland 21237
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3401 Enterprise Place
Beachwood, Ohio 44122
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9001 Wilshire Boulevard
Beverly Hills, California 90211
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950 Glades Road
Boca Raton, Florida 33431
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Bonn,
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Boston, Massachusetts 02114
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Campbell, California 95008
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6035 Fairview Road
Charlotte, North Carolina 28210
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Cincinnati, Ohio 45242
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Dallas, Texas 75231
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7760 France Avenue South
Edina, Minnesota 55435
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Encino, California 91436
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Fort Myers, Florida 33912
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Golden, Colorado 80401
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Knoxville, Tennessee 37909
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Ladson, South Carolina 29456
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Loma Linda University
Loma Linda, California 92354
(909) 558-4000
Loma Linda University Loma Linda University (LLU) is a Seventh-day Adventist educational health-sciences institution with...
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360 Merrick Road
Lynbrook, New York 11563
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502 East New Haven Avenue
Melbourne, Florida 32901
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Nashville, Tennessee 37203
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1800 Republic Road
Norfolk, Virginia 23451
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Oceanside, California 92056
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Oklahoma City, Oklahoma 73104
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Palm Beach Gardens, Florida 33410
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Pensacola, Florida 32503
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Philadelphia, Pennsylvania 19107
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Portland, Oregon 97210
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Reno, Nevada 89502
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Saint Louis, Missouri 63110
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1445 Bush Street
San Francisco, California 94107
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San Francisco, California 94107
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Santa Barbara, California 93103
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Torrance, California 90503
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Tucson, Arizona 85704
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West Des Moines, Iowa 50266
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250 Avenue K Southwest
Winter Haven, Florida 33880
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