A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
NCT ID: NCT02247479
Last Updated: 2019-06-26
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
906 participants
INTERVENTIONAL
2014-09-18
2018-01-29
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
QUADRUPLE
Study Groups
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Lampalizumab Once in Every 4 Weeks (Q4W)
Participants will receive 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections for approximately 96 weeks.
Lampalizumab
Participants will receive 10 mg dose of lampalizumab administered intravitreally.
Lampalizumab Once in Every 6 Weeks (Q6W)
Participants will receive 10 mg dose of lampalizumab administered by intravitreal injections for approximately 96 weeks.
Lampalizumab
Participants will receive 10 mg dose of lampalizumab administered intravitreally.
Sham Comparator
Participants will receive sham comparator Q4W or Q6W for 96 weeks.
Sham
A sham injection is a procedure that mimics an intravitreal injection of lampalizumab.
Interventions
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Lampalizumab
Participants will receive 10 mg dose of lampalizumab administered intravitreally.
Sham
A sham injection is a procedure that mimics an intravitreal injection of lampalizumab.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy
* GA in either eye due to causes other than AMD
* Previous treatment with eculizumab, lampalizumab and/or fenretinide
50 Years
ALL
No
Sponsors
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Hoffmann-La Roche
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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Uni of Alabama At Birmingham Clinical Research Unit
Birmingham, Alabama, United States
Retinal Research Institute, LLC
Phoenix, Arizona, United States
Retina Centers P.C.
Tucson, Arizona, United States
California Retina Consultants
Bakersfield, California, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
The Gavin Herbert Eye Institute - UC, Irvine
Irvine, California, United States
Jules Stein Eye Institute/ UCLA
Los Angeles, California, United States
East Bay Retina Consultants
Oakland, California, United States
Southern CA Desert Retina Cons
Palm Desert, California, United States
W Coast Retina Med Group Inc
San Francisco, California, United States
UCSF; Ophthalmology
San Francisco, California, United States
Orange County Retina Med Group
Santa Ana, California, United States
California Retina Consultants
Santa Barbara, California, 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
Bascom Palmer Eye Institute
Palm Beach Gardens, Florida, United States
Retina Specialty Institute
Pensacola, Florida, United States
Fort Lauderdale Eye Institute
Plantation, Florida, United States
Retina Vitreous Assoc of FL
St. Petersburg, Florida, United States
Southern Vitreoretinal Assoc
Tallahassee, Florida, United States
Retina Associates of Florida, LLC
Tampa, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
Georgia Retina PC
Marietta, Georgia, United States
Retina Consultants of Hawaii
‘Aiea, Hawaii, United States
Northwestern Medical Group/Northwestern University
Chicago, Illinois, United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, United States
Midwest Eye Institute Northside
Indianapolis, Indiana, United States
Wolfe Eye Clinic
West Des Moines, Iowa, United States
Retina Associates
Shawnee Mission, Kansas, United States
Lahey Clinic Med Ctr
Lexington, Kentucky, United States
Retina Associates of Kentucky
Lexington, Kentucky, United States
Maine Eye Center
Portland, Maine, United States
Retina Specialists
Towson, Maryland, United States
Tufts Medical Center Research
Boston, Massachusetts, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Vitreo-Retinal Associates, PC
Worcester, Massachusetts, United States
Vitreo-Retinal Associates
Grand Rapids, Michigan, United States
Specialty Eye Institute
Jackson, Michigan, United States
Assoc Retinal Consultants PC
Royal Oak, Michigan, United States
Retina Consultants of Michigan
Southfield, Michigan, United States
Eye Surgical Associates
Lincoln, Nebraska, United States
Retina Consultants of Nevada
Las Vegas, Nevada, United States
Retina Center of New Jersey
Bloomfield, New Jersey, United States
New Jersey Retina Research Foundation
Edison, New Jersey, United States
Delaware Valley Retina Assoc
Lawrenceville, New Jersey, United States
Long Is. Vitreoretinal Consult
Hauppauge, New York, United States
Opthalmic Consultants of LI
Lynbrook, New York, United States
New York Eye & Ear Infirmary
New York, New York, United States
Retina Consultants of Western New York
Orchard Park, New York, United States
Retina Vit Surgeons/Central NY
Syracuse, New York, United States
Western Carolina Retinal Associate PA
Asheville, North Carolina, United States
Wake Forest Baptist Health Eye Centre
Winston-Salem, North Carolina, United States
Retina Assoc of Cleveland Inc
Beachwood, Ohio, United States
Cleveland Clinic Foundation; Cole Eye Institute
Cleveland, Ohio, United States
Retina Vitreous Consultants
Monroeville, Pennsylvania, United States
Associates in Ophthalmology
West Mifflin, Pennsylvania, United States
Charleston Neuroscience Inst
Ladson, South Carolina, United States
Tennessee Retina PC.
Nashville, Tennessee, United States
Vanderbilt
Nashville, Tennessee, United States
Retina Res Institute of Texas
Abilene, Texas, United States
Texas Retina Associates
Arlington, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Retina Research Center
Austin, Texas, United States
UT Southwestern MC at Dallas
Dallas, Texas, United States
Valley Retina Institute P.A.
McAllen, Texas, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, United States
Retina Associates of Utah
Salt Lake City, Utah, United States
Eye Surgeons of Richmond Inc. dba Virginia Eye Institute
Richmond, Virginia, United States
Retina Institute of Virginia
Richmond, Virginia, United States
Virginia Retina Center
Warrenton, Virginia, United States
Retina Center Northwest
Silverdale, Washington, United States
Spokane Eye Clinical Research
Spokane, Washington, United States
West Virginia University Eye Institute
Morgantown, West Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
Organizacion Medica de Investigacion
Buenos Aires, , Argentina
Fundacion Zambrano
CABA, , Argentina
Oftar
Mendoza, , Argentina
Microcirugía Ocular S.A
Rosario, , Argentina
Grupo Laser Vision
Rosario, , Argentina
Eyeclinic Albury Wodonga
Albury, New South Wales, Australia
Marsden Eye Research Centre
Parramatta, New South Wales, Australia
Save Sight Institute
Sydney, New South Wales, Australia
Sydney West Retina
Westmead, New South Wales, Australia
Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde
Linz, , Austria
CHU Brugmann (Victor Horta)
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
UZ Leuven Sint Rafael
Leuven, , Belgium
CHU Sart-Tilman
Liège, , Belgium
Calgary Retina Consultants
Calgary, Alberta, Canada
University of British Columbia
Vancouver, British Columbia, Canada
QEII - HSC Department of Ophthalmology
Halifax, Nova Scotia, Canada
University of Ottawa Eye Institute
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St. Michael'S Hospital
Toronto, Ontario, Canada
University Health Network Toronto Western Hospital
Toronto, Ontario, Canada
Institut De L'Oeil Des Laurentides
Boisbriand, Quebec, Canada
Sjællands Universitetshospital, Roskilde; Øjenafdelingen
Roskilde, , Denmark
Chi De Creteil; Ophtalmologie
Créteil, , France
Centre Odeon; Exploration Ophtalmologique
Paris, , France
Hopital Lariboisiere; Ophtalmologie
Paris, , France
Centre Ophtalmologique; Imagerie et laser
Paris, , France
Ch Pitie Salpetriere; Ophtalmologie
Paris, , France
CHU Poitiers - CHR La Miletrie; Ophtalmologie
Poitiers, , France
Universitäts-Augenklinik Bonn
Bonn, , Germany
Universitätsklinikum Köln; Augenklinik
Cologne, , Germany
Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde
Göttingen, , Germany
Medizinische Hochschule Hannover, Klinik für Augenheilkunde
Hanover, , Germany
Universitätskliniikum Schleswig-Holstein, Campus Lübeck, Klinik für Augenheilkunde
Lübeck, , Germany
Augenabteilung am St. Franziskus-Hospital
Münster, , Germany
Universitätsklinikum Münster; Augenheilkunde
Münster, , Germany
Budapest Retina Associates Kft.
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
Debrecem, , Hungary
Ganglion Medial Center
Pécs, , Hungary
Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche
Rome, Lazio, Italy
Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
Rome, Lazio, Italy
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica
Milan, Lombardy, Italy
Azienda Ospedaliero Universitaria Di Sassari;U.O. Oculistica
Sassari, Sardinia, Italy
Macula Retina Consultores
Mexico City, , Mexico
Hospital de la Ceguera APEC
Mexico City, , Mexico
Academisch Medisch Centrum Universiteit Amsterdam
Amsterdam, , Netherlands
Leids Universitair Medisch Centrum
Leiden, , Netherlands
Radboud University Nijmegen Medical Centre; Ophthalmology
Nijmegen, , Netherlands
CLINICA RICARDO PALMA; Oftalmologos Contreras
Lima, , Peru
Clinica Anglo Americana
Lima, , Peru
OFTALMIKA Sp. z o.o
Bydgoszcz, , Poland
Optimum Profesorskie Centrum Okulistyki
Gdansk, , Poland
Gabinet Okulistyczny Prof Edward Wylegala
Katowice, , Poland
SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej
Krakow, , Poland
Nemocnica sv. Michala, a.s.
Bratislava, , Slovakia
Fakultna nemocnica Trencin Ocna klinika
Trenčín, , Slovakia
Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie
Žilina, , Slovakia
Hospital Universitari de Bellvitge; Servicio de Oftalmologia
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital General de Catalunya
San Cugat Del Valles, Barcelona, Spain
Instituto Clinico Quirurgico de Oftalmologia - ICQO
Bilbao, Guipuzcoa, Spain
VISSUM Instituto Oftalmológico de Alicante
Alicante, , Spain
Institut de la Macula i la retina
Barcelona, , Spain
FISABIO. Fundación Oftalmologica del Mediterraneo
Valencia, , Spain
Hospital Universitario Rio Hortega; Servicio de Oftalmologia
Valladolid, , Spain
Stadtspital Triemli; Augenklinik
Zurich, , Switzerland
Ayr Hospital
Ayr, , United Kingdom
The Princess Alexandra Eye Pavilion
Edinburgh, , United Kingdom
Frimley Park Hospital
Frimley, , United Kingdom
Royal Hallamshire Hospita
Sheffield, , United Kingdom
Countries
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References
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Salvi A, Cluceru J, Gao SS, Rabe C, Schiffman C, Yang Q, Lee AY, Keane PA, Sadda SR, Holz FG, Ferrara D, Anegondi N. Deep Learning to Predict the Future Growth of Geographic Atrophy from Fundus Autofluorescence. Ophthalmol Sci. 2024 Oct 23;5(2):100635. doi: 10.1016/j.xops.2024.100635. eCollection 2025 Mar-Apr.
Cluceru J, Anegondi N, Gao SS, Lee AY, Lad EM, Chakravarthy U, Yang Q, Steffen V, Friesenhahn M, Rabe C, Ferrara D. Topographic Clinical Insights From Deep Learning-Based Geographic Atrophy Progression Prediction. Transl Vis Sci Technol. 2024 Aug 1;13(8):6. doi: 10.1167/tvst.13.8.6.
Bressler NM, Freund KB, Bakri SJ, Kim JE, Ferrara D, Brittain C, Pickthorn K, Lin H, Sun C, Martin J. Intraocular Pressure Outcomes After Lampalizumab Injections in Patients With Geographic Atrophy. JAMA Ophthalmol. 2024 Aug 1;142(8):772-776. doi: 10.1001/jamaophthalmol.2024.2061.
Chang DS, Callaway NF, Steffen V, Csaky K, Guymer RH, Birch DG, Patel PJ, Ip M, Gao SS, Briggs J, Honigberg L, Lai P, Ferrara D, Sepah YJ. Macular Sensitivity Endpoints in Geographic Atrophy: Exploratory Analysis of Chroma and Spectri Clinical Trials. Ophthalmol Sci. 2023 Jun 12;4(1):100351. doi: 10.1016/j.xops.2023.100351. eCollection 2024 Jan-Feb.
Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3.
Miere A, Capuano V, Kessler A, Zambrowski O, Jung C, Colantuono D, Pallone C, Semoun O, Petit E, Souied E. Deep learning-based classification of retinal atrophy using fundus autofluorescence imaging. Comput Biol Med. 2021 Mar;130:104198. doi: 10.1016/j.compbiomed.2020.104198. Epub 2020 Dec 28.
Heier JS, Pieramici D, Chakravarthy U, Patel SS, Gupta S, Lotery A, Lad EM, Silverman D, Henry EC, Anderesi M, Tschosik EA, Gray S, Ferrara D, Guymer R; Chroma and Spectri Study Investigators. Visual Function Decline Resulting from Geographic Atrophy: Results from the Chroma and Spectri Phase 3 Trials. Ophthalmol Retina. 2020 Jul;4(7):673-688. doi: 10.1016/j.oret.2020.01.019. Epub 2020 Jan 31.
Holz FG, Sadda SR, Busbee B, Chew EY, Mitchell P, Tufail A, Brittain C, Ferrara D, Gray S, Honigberg L, Martin J, Tong B, Ehrlich JS, Bressler NM; Chroma and Spectri Study Investigators. Efficacy and Safety of Lampalizumab for Geographic Atrophy Due to Age-Related Macular Degeneration: Chroma and Spectri Phase 3 Randomized Clinical Trials. JAMA Ophthalmol. 2018 Jun 1;136(6):666-677. doi: 10.1001/jamaophthalmol.2018.1544.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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2014-000107-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GX29176
Identifier Type: -
Identifier Source: org_study_id
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