A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
NCT ID: NCT02247531
Last Updated: 2019-10-15
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
975 participants
INTERVENTIONAL
2014-10-06
2018-01-23
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 mg (milligrams) dose of lampalizumab by intravitreal injection, Q4W, starting at the Day 1 visit for approximately 92 weeks.
Lampalizumab
10 mg dose of lampalizumab administered intravitreally.
Lampalizumab once in every 6 weeks (Q6W)
Participants will receive 10 mg dose of lampalizumab by intravitreal injection, Q6W, starting at the Day 1 visit for approximately 90 weeks.
Lampalizumab
10 mg dose of lampalizumab administered intravitreally.
Sham Comparator
Participants will receive sham comparator, Q4W, starting at the Day 1 visit for approximately 92 weeks or Q6W, starting at the Day 1 visit for approximately 90 weeks.
Sham Comparator
A sham injection is a procedure that mimics an intravitreal injection of lampalizumab.
Interventions
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Lampalizumab
10 mg dose of lampalizumab administered intravitreally.
Sham Comparator
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
* Well demarcated area(s) of Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD) with no evidence of prior or active choroidal neovascularization (CNV) in both eyes
Exclusion Criteria
* Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy
* Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation)
* 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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Associated Retina Consultants
Phoenix, Arizona, United States
Retina Associates Southwest PC
Tucson, Arizona, United States
Retina Consultants of Orange County
Fullerton, California, United States
UCSD Shiley Eye Center
La Jolla, California, United States
Jules Stein Eye Institute/ UCLA
Los Angeles, California, United States
N CA Retina Vitreous Assoc
Mountain View, California, United States
Byers Eye Insitute at Stanford
Palo Alto, California, United States
Retina Consultants, San Diego
Poway, California, United States
University of California, Davis, Eye Center
Sacramento, California, United States
Retinal Consultants Med Group
Sacramento, California, United States
California Retina Consultants
Santa Barbara, California, United States
Bay Area Retina Associates
Walnut Creek, California, United States
University of Colorado
Aurora, Colorado, United States
Retina Consultants of Southern
Colorado Springs, Colorado, United States
Colorado Retina Associates, PC
Golden, Colorado, United States
New England Retina Associates
Hamden, Connecticut, United States
Retina Group of New England
Waterford, Connecticut, United States
Retina Group of Florida
Fort Lauderdale, Florida, United States
Retina Health Center
Fort Myers, Florida, United States
Bascom Palmer Eye Institute
Naples, Florida, United States
Retina Vitreous Assoc of FL
St. Petersburg, Florida, United States
Southern Vitreoretinal Assoc
Tallahassee, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Wolfe Eye Clinic
West Des Moines, Iowa, United States
Vitreo Retinal Consultants
Wichita, Kansas, United States
Paducah Retinal Center
Paducah, Kentucky, United States
The Retina Care Center
Baltimore, Maryland, United States
Wilmer Eye Institute
Baltimore, Maryland, United States
Retina Group of Washington
Chevy Chase, Maryland, United States
Retina Specialists
Towson, Maryland, United States
Mass Eye and Ear Infirmary
Boston, Massachusetts, United States
University of Michigan, Kellogg Eye Center
Ann Arbor, Michigan, United States
Kresge Eye Institute
Detroit, Michigan, United States
Vitreoretinal Surgery
Edina, Minnesota, United States
Midwest Vision Research Foundation
Chesterfield, Missouri, United States
UNMC Truhlsen Eye Institute
Omaha, Nebraska, United States
Sierra Eye Associates
Reno, Nevada, United States
Mid Atlantic Retina - Wills Eye Hospital
Cherry Hill, New Jersey, United States
Retinal & Ophthalmic Cons PC
Northfield, New Jersey, United States
Retina Associates of NJ
Teaneck, New Jersey, United States
New York Weil Cornell Med Ctr
New York, New York, United States
Vitreous-Retina-Macula
New York, New York, United States
Retina Assoc of Western NY
Rochester, New York, United States
Western Carolina Retinal Associate PA
Asheville, North Carolina, United States
Char Eye Ear &Throat Assoc
Charlotte, North Carolina, United States
Duke University Eye Center; Vitreoretinal
Durham, North Carolina, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
OSU Eye Physicians & Surgeons
Columbus, Ohio, United States
Retina & Vitreous Center of Southern Oregon
Ashland, Oregon, United States
Retina Northwest
Portland, Oregon, United States
Oregon HSU; Casey Eye Institute
Portland, Oregon, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, United States
Allegheny Ophthalmic & Orbital
Pittsburgh, Pennsylvania, United States
MUSC Storm eye institute
Charleston, South Carolina, United States
Palmetto Retina Center
Florence, South Carolina, United States
Charleston Neuroscience Inst
Ladson, South Carolina, United States
Black Hills Eye Institute
Rapid City, South Dakota, United States
Southeastern Retina Associates Chattanooga
Chattanooga, Tennessee, United States
Charles Retina Institution
Germantown, Tennessee, United States
Retina Res Institute of Texas
Abilene, Texas, United States
Texas Retina Associates
Dallas, Texas, United States
Retina Consultants of Houston
Houston, Texas, United States
Scott and White Hospital
Temple, Texas, United States
Retina Consultants of Houston
The Woodlands, Texas, United States
Univ of Virginia Ophthalmology
Charlottesville, Virginia, United States
Vitreoretinal Associates of Washington
Bellevue, Washington, United States
Oftalmos
Capital Federal, , Argentina
Instituto de la Vision
Capital Federal, , Argentina
Hospital El Cruce
San Juan Bautista, , Argentina
Queensland Eye Institute
Brisbane, Queensland, Australia
Adelaide Eye and Retina Centre
Adelaide, South Australia, Australia
Vision Eye Institute Eastern
Box Hill, Victoria, Australia
Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria, Australia
The Lions Eye Institute
Nedlands, Western Australia, Australia
Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie
Vienna, , Austria
CHU Brugmann (Victor Horta)
Brussels, , Belgium
UZ Leuven Sint Rafael
Leuven, , Belgium
Glostrup Hospital, Øjenafdelingen, Forskningsafsnit Ø37
Glostrup Municipality, , Denmark
Hopital Pellegrin; Ophtalmologie
Bordeaux, , France
CHU Bocage; Ophtalmologie
Dijon, , France
Hopital de la croix rousse; Ophtalmologie
Lyon, , France
Centre Paradis Monticelli; Ophtalmologie
Marseille, , France
Hopital Hotel Dieu Et Hme; Clinique Ophtalmologique
Nantes, , France
CHNO des Quinze Vingts; Ophtalmologie
Paris, , France
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
Freiburg im Breisgau, , Germany
Universitätsklinik Heidelberg; Augenklinik
Heidelberg, , Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik
Ludwigshafen, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik
Mainz, , Germany
LMU Klinikum der Universität, Augenklinik
München, , Germany
Klinikum rechts der Isar der TU München; Augenklinik
München, , Germany
Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde
Regensburg, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR
Budapest, , Hungary
Semmelweis Egyetem AOK, Szemeszeti Klinika
Budapest, , Hungary
Ganglion Medial Center
Pécs, , Hungary
UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA
Genoa, Liguria, Italy
Irccs Ospedale San Raffaele;U.O. Oculistica
Milan, Lombardy, Italy
ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)
Milan, Lombardy, Italy
A.S.L. to1 Presidio Ospedaliero Sperino Oftalmico
Turin, Piedmont, Italy
Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica
Florence, Tuscany, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica
Udine, Veneto, Italy
Hospital Nuestra Señora de La Luz
Mexico City, , Mexico
Hospital Universitario de Monterrey
Monterrey, , Mexico
Instituto Mexicano de Oftalmologia I.A.P.
Querétaro, , Mexico
Radboud University Nijmegen Medical Centre; Ophthalmology
Nijmegen, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Mácula D&T
Lima, , Peru
TG Laser Oftalmica
Lima, , Peru
Centro de Investigacion Oftalmolaser
Lima, , Peru
OFTALMIKA Sp. z o.o
Bydgoszcz, , Poland
Szpital Specjalistyczny nr 1; Oddzial Okulistyki
Bytom, , Poland
Klinika Okulistyczna Jasne Błonia
Lodz, , Poland
Uniwersytecki Szpital Kliniczny; Klinika Okulistyki
Wroclaw, , Poland
AIBILI - Association for Innovation and Biomedical Research on Light
Coimbra, , Portugal
Espaco Medico Coimbra
Coimbra, , Portugal
Hospital de Santa Maria; Servico de Oftalmologia
Lisbon, , Portugal
Hospital de Sao Joao; Servico de Oftalmologia
Porto, , Portugal
SAHI "Republic clinical ophthalmological hospial of Ministry of Heal of Tatarstan Republic"
Kazan', , Russia
FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences
Moscow, , Russia
St. Educ.Inst. of High Prof.Education "Samara State Medical University"; Chair of ophathalmology
Samara, , Russia
FNsP F. D. Roosevelta Banska Bystrica, II.Ocna klinika SZU
Banská Bystrica, , Slovakia
Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda Ocna klinika SZU a UNB
Bratislava, , Slovakia
Instituto Oftalmologico Gomez Ulla
Santiago de Compostela, LA Coruña, Spain
Clinica Universitaria de Navarra; Servicio de Oftalmologia
Pamplona, Navarre, Spain
Hospital Perpetuo Socorro; Servicio de Oftalmología
Albacete, , Spain
Instituto de microcirugia ocular
Barcelona, , Spain
VISSUM Madrid Santa Hortensia
Madrid, , Spain
Hospital Universitario Clínico San Carlos; Servicio de Oftalmologia
Madrid, , Spain
Hospital Universitario la Fe: Servicio de Oftalmologia
Valencia, , Spain
St Eriks Eye Hospital
Stockholm, , Sweden
Inselspital Bern, Universitätsklinik für Augenheilkunde
Bern, , Switzerland
Vista Klinik Binningen
Binningen, , Switzerland
Hacettepe University Medical Faculty; Department of Ophthalmology
Ankara, , Turkey (Türkiye)
Ankara University Medical Faculty; Department of Ophthalmology
Ankara, , Turkey (Türkiye)
Ankara Baskent University Medical Faculty; Department of Ophthalmology
Ankara, , Turkey (Türkiye)
Istanbul University Istanbul Medical Faculty; Department of Ophthalmology
Istanbul, , Turkey (Türkiye)
Ege University Medical Faculty; Department of Ophthalmology
Izmir, , Turkey (Türkiye)
Dokuz Eylul University Medical Faculty; Department of Ophthalmology
Izmir, , Turkey (Türkiye)
Royal Victoria Hospital
Belfast, , United Kingdom
Bradford Royal Infirmary
Bradford, , United Kingdom
Bristol Eye Hospital
Bristol, , United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
Gloucestershire Hospitals NHS Foundation Trust
Gloucestershire, , United Kingdom
Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre
Liverpool, , United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London, , United Kingdom
Kings College Hospital
London, , United Kingdom
Macular Treatment Centre; Royal Eye Hospital
Manchester, , United Kingdom
Hillingdon Hospital
Middx, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
The Royal Wolverhampton Hospitals NHS Trust
Wolverhampton, , United Kingdom
The York Hospital
York, , 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.
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: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2014-000106-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GX29185
Identifier Type: -
Identifier Source: org_study_id
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