A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Participants With Geographic Atrophy
NCT ID: NCT02288559
Last Updated: 2019-09-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
96 participants
INTERVENTIONAL
2015-03-30
2017-06-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Lampalizumab: Open-label Safety Run-In
Participants will receive 10 milligrams (mg) lampalizumab intravitreally Q2W during the safety run-in period.
Lampalizumab
10 mg dose of lampalizumab administered intravitreally
Q2W Lampalizumab: Randomized Treatment
Participants will receive 10 mg dose of lampalizumab intravitreally Q2W during the 24-week treatment period.
Lampalizumab
10 mg dose of lampalizumab administered intravitreally
Q4W Lampalizumab: Randomized Treatment
Participants will receive 10 mg dose of lampalizumab intravitreally Q4W during the 24-week treatment period.
Lampalizumab
10 mg dose of lampalizumab administered intravitreally
Sham: Randomized Treatment
Participants randomized to control arms will receive sham injections, that mimics intravitreal injection of lampalizumab.
Sham
Sham injection will be administered as a matching intravitreal injection of lampalizumab.
Interventions
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Sham
Sham injection will be administered as a matching intravitreal injection of lampalizumab.
Lampalizumab
10 mg dose of lampalizumab administered intravitreally
Eligibility Criteria
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Inclusion Criteria
* Women of child bearing potential and men should remain abstinent or use contraceptive methods
Exclusion Criteria
* 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
60 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Barnet Dulaney Perkins Eye Center
Mesa, Arizona, United States
University of Arizona; Banner University Medical, Department of Opthalmology
Tucson, Arizona, United States
Northwest Arkansas Retina Associates
Springdale, Arkansas, United States
Retinal Diagnostic Center
Campbell, California, United States
The Retina Partners
Encino, California, United States
Loma Linda University
Loma Linda, California, United States
San Diego Retina Associates
Oceanside, California, United States
West Coast Retina Medical Group
San Francisco, California, United States
California Retina Consultants
Santa Barbara, California, United States
Colorado Retina Associates, PC
Golden, Colorado, United States
Florida Eye Microsurgical Inst
Boynton Beach, Florida, United States
National Ophthalmic Research Institute
Fort Myers, Florida, United States
Florida Eye Associates
Melbourne, Florida, United States
Retina Care Specialists
Palm Beach Gardens, Florida, United States
Retina Specialty Institute
Pensacola, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Wolfe Eye Clinic
West Des Moines, Iowa, United States
Elman Retina Group
Baltimore, Maryland, United States
Vitreoretinal Surgery
Edina, Minnesota, United States
The Retina Institute
St Louis, Missouri, United States
Sierra Eye Associates
Reno, Nevada, United States
Eye Associates of New Mexico
Albuquerque, New Mexico, United States
Western Carolina Retinal Associate PA
Asheville, North Carolina, United States
Char Eye Ear &Throat Assoc
Charlotte, North Carolina, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Retina Assoc of Cleveland Inc
Cleveland, Ohio, United States
Dean McGee Eye Institute
Oklahoma City, Oklahoma, United States
Retina Cons of Charleston
Charleston, South Carolina, United States
Carolina Retina Center PA
Columbia, South Carolina, United States
Charles Retina Institution
Germantown, Tennessee, United States
Southeastern Retina Associates
Knoxville, Tennessee, United States
Tennessee Retina PC.
Nashville, Tennessee, United States
W Texas Retina Consultants PA
Abilene, Texas, United States
Texas Retina Associates
Dallas, Texas, United States
Retina Specialists
DeSoto, Texas, United States
Wagner Macula & Retina Center
Norfolk, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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GX29455
Identifier Type: -
Identifier Source: org_study_id
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