A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Participants With Geographic Atrophy



Status:Completed
Healthy:No
Age Range:60 - Any
Updated:2/21/2019
Start Date:March 30, 2015
End Date:June 2, 2017

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A Phase II, Multicenter, Randomized, Single-Masked, Sham Injection-Controlled Exposure-Response Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Patients With Geographic Atrophy

This multicenter, randomized, single-masked, sham injection-controlled study will investigate
the exposure-response and safety of lampalizumab administered intravitreally every 2 weeks
(Q2W) or every 4 weeks (Q4W) for 24 weeks in participants with geographic atrophy (GA)
secondary to age-related macular degeneration (AMD). A safety run-in assessment will be
conducted prior to initiating enrollment in the randomized study.


Inclusion Criteria:

- Complement Factor I (CFI) profile biomarker-positive result

- Women of child bearing potential and men should remain abstinent or use contraceptive
methods

Exclusion Criteria:

- History of vitrectomy surgery, submacular surgery, or other surgical intervention for
AMD in study eye

- Previous subfoveal focal laser photocoagulation in study eye

- Laser photocoagulation in the study eye

- Prior treatment with external-beam radiation therapy or transpupillary thermotherapy
in study eye

- Previous intravitreal drug administration in study eye. A single intraoperative
administration of a corticosteroid during cataract surgery at least 3 months prior to
screening is permitted

- Previous cell-based intraocular treatment in study eye

- Intraocular surgery in study eye

- Uncontrolled glaucoma and history of glaucoma-filtering surgery in study eye

- History of corneal transplant in study eye

- GA in either eye due to causes other than AMD

- Proliferative diabetic retinopathy in either eye

- Active or history of neovascular (wet) AMD in either eye

- History of idiopathic or autoimmune-associated uveitis, ocular or intraocular
conditions, and infectious or inflammatory ocular disease

- Active uveitis and infectious conjunctivitis, keratitis, scleritis or endophthalmitis

- Previous systemic treatment with complement inhibitor and with inhibitors/modulators
of visual cycle

- Previous expression vector mediated intraocular treatments

- Uncontrolled blood pressure and atrial fibrillation

- Medical conditions associated with clinically significant risk for bleeding-

- Predisposition or history of increased risk for infection

- Active malignancy within the previous 12 months except for appropriately treated
carcinoma in situ of cervix, resolved non-melanoma skin carcinoma, and prostate cancer
with a Gleason score of less than or equal to 6, and a stable prostate-specific
antigen for greater than or equal to (>/=) 12 months

- History of severe allergic reaction or anaphylactic reaction to a biologic agent or
known hypersensitivity to any component of lampalizumab injection

- Women of child bearing potential must have a negative serum pregnancy test within 28
days prior to initiation of study treatment

- Previous participation in other studies of investigational drugs
We found this trial at
36
sites
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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Baltimore, Maryland 21237
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1717 Woolbright Road
Boynton Beach, Florida 33426
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Campbell, California 95008
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3531 Mary Ader Avenue
Charleston, South Carolina 29414
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6035 Fairview Road
Charlotte, North Carolina 28210
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Cincinnati, Ohio 45242
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Cleveland, Ohio 44122
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Columbia, South Carolina 29223
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Dallas, Texas 75231
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2625 Bolton Boone Drive
DeSoto, Texas 75115
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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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1432 Kimbrough Road
Germantown, Tennessee 38138
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Golden, Colorado 80401
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Knoxville, Tennessee 37909
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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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502 East New Haven Avenue
Melbourne, Florida 32901
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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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Phoenix, Arizona 85016
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Reno, Nevada 89502
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Saint Louis, Missouri 63110
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San Francisco, California 94107
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Santa Barbara, California 93103
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601 Maple Drive
Springdale, Arkansas 72764
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West Des Moines, Iowa 50266
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