Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)
A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Lampalizumab in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration Who Have Completed a Roche-Sponsored Study
2 other identifiers
interventional
994
18 countries
202
Brief Summary
This multicenter open-label extension study is designed to evaluate the safety and tolerability of lampalizumab intravitreal injections in participants with GA secondary to age-related macular degeneration (AMD) who completed 96 weeks of treatment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531). The extension will enroll participants from the parent studies who received investigational lampalizumab, as well as lampalizumab-naive participants exposed to sham comparator. All participants will receive open-label lampalizumab in the present study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2016
202 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2016
CompletedFirst Posted
Study publicly available on registry
April 20, 2016
CompletedStudy Start
First participant enrolled
July 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2018
CompletedResults Posted
Study results publicly available
February 15, 2019
CompletedMarch 6, 2019
January 1, 2019
1.5 years
April 18, 2016
January 23, 2019
February 19, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Percentage of Participants With Ocular Adverse Events (AEs) by Severity
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.
Up to approximately one year
Percentage of Participants With Systemic (Non-Ocular) AEs by Severity
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test.
Up to approximately one year
Percentage of Participants With Anti-Lampalizumab Antibodies
The immunogenicity analysis included participants with at least one predose and one postdose anti-lampalizumab antibodies assessment. Predose was defined as prior to the first dose in the extension study for the prior sham participants, and prior to the first dose in the parent study for the prior lampalizumab participants.
Week 48
Study Arms (2)
Lampalizumab Every 4 Weeks
EXPERIMENTALParticipants who received either lampalizumab or sham comparator every 4 weeks in one of the parent studies and completed the Week 96 visit will receive open-label lampalizumab as 10 milligrams (mg) via ITV injection, administered every 4 weeks.
Lampalizumab Every 6 Weeks
EXPERIMENTALParticipants who received either lampalizumab or sham comparator every 6 weeks in one of the parent studies and completed the Week 96 visit will receive open-label lampalizumab as 10 mg via ITV injection, administered every 6 weeks.
Interventions
Lampalizumab 10 mg will be administered every 4 or 6 weeks according to the frequency given during participation in the parent study.
Eligibility Criteria
You may qualify if:
- Previous enrollment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531) with completion of treatment and the Week 96 visit
- Agreement to remain abstinent or use a reliable form of contraception among all men and among women of child-bearing potential
You may not qualify if:
- Concurrent ocular conditions that contraindicate use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications
- Concurrent disease, metabolic dysfunction, or physical or laboratory finding that contraindicates use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications
- Increased risk of infection
- Pregnancy or lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (208)
Uni of Alabama At Birmingham Clinical Research Unit
Birmingham, Alabama, 35233, United States
Retinal Research Institute, LLC
Phoenix, Arizona, 85014, United States
Associated Retina Consultants
Phoenix, Arizona, 85020, United States
Retina Centers P.C.
Tucson, Arizona, 85704, United States
Retina Associates Southwest PC
Tucson, Arizona, 85750, United States
California Retina Consultants
Bakersfield, California, 93309, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211, United States
Retina Consultants of Orange County
Fullerton, California, 92835, United States
UCSD Shiley Eye Center
La Jolla, California, 92093-0946, United States
Jules Stein Eye Institute/ UCLA
Los Angeles, California, 90095-7000, United States
N CA Retina Vitreous Assoc
Mountain View, California, 94040, United States
East Bay Retina Consultants
Oakland, California, 94609, United States
Southern CA Desert Retina Cons
Palm Desert, California, 92211, United States
Byers Eye Insitute at Stanford
Palo Alto, California, 94303, United States
Retina Consultants, San Diego
Poway, California, 92064, United States
University of California, Davis, Eye Center
Sacramento, California, 95817, United States
Retinal Consultants Med Group
Sacramento, California, 95841, United States
W Coast Retina Med Group Inc
San Francisco, California, 94107, United States
UCSF Comprehensive Cancer Ctr; Ophthalmology
San Francisco, California, 94143, United States
Orange County Retina Med Group
Santa Ana, California, 92705, United States
California Retina Consultants
Santa Barbara, California, 93103, United States
Bay Area Retina Associates
Walnut Creek, California, 94598, United States
University of Colorado
Aurora, Colorado, 80045, United States
Retina Consultants of Southern
Colorado Springs, Colorado, 80909, United States
Colorado Retina Associates, PC
Golden, Colorado, 80201, United States
Retina Group of New England
New London, Connecticut, 06320, United States
Florida Eye Microsurgical Inst
Boynton Beach, Florida, 33426, United States
Retina Group of Florida
Fort Lauderdale, Florida, 33308, United States
Retina Health Center
Fort Myers, Florida, 33907, United States
National Ophthalmic Research Institute
Fort Myers, Florida, 33912, United States
Florida Eye Associates
Melbourne, Florida, 32901, United States
Bascom Palmer Eye Institute
Naples, Florida, 34103, United States
Retina Care Specialists
Palm Beach Gardens, Florida, 33410, United States
Bascom Palmer Eye Institute
Palm Beach Gardens, Florida, 33418, United States
Retina Specialty Institute
Pensacola, Florida, 32503, United States
Fort Lauderdale Eye Institute
Plantation, Florida, 33324, United States
Retina Vitreous Assoc of FL
St. Petersburg, Florida, 33711, United States
Southern Vitreoretinal Assoc
Tallahassee, Florida, 32308, United States
Retina Associates of Florida, LLC
Tampa, Florida, 33609, United States
University of South Florida
Tampa, Florida, 33612, United States
Southeast Retina Center
Augusta, Georgia, 30909, United States
Georgia Retina PC
Marietta, Georgia, 30060, United States
Retina Consultants of Hawaii
‘Aiea, Hawaii, 96701, United States
Midwest Eye Institute Northside
Indianapolis, Indiana, 46290, United States
Wolfe Eye Clinic
West Des Moines, Iowa, 50266, United States
Retina Associates
Shawnee Mission, Kansas, 66204, United States
Vitreo Retinal Consultants
Wichita, Kansas, 67214, United States
Lahey Clinic Med Ctr
Lexington, Kentucky, 02421, United States
Retina Associates of Kentucky
Lexington, Kentucky, 40509, United States
Paducah Retinal Center
Paducah, Kentucky, 42001, United States
Maine Eye Center
Portland, Maine, 04102, United States
The Retina Care Center
Baltimore, Maryland, 21209, United States
Wilmer Eye Institute
Baltimore, Maryland, 21287, United States
Retina Group of Washington
Chevy Chase, Maryland, 20815, United States
Retina Specialists
Towson, Maryland, 21204, United States
Tufts Medical Center Research
Boston, Massachusetts, 02111, United States
Mass Eye and Ear Infirmary
Boston, Massachusetts, 02114, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
Vitreo-Retinal Associates, PC
Worcester, Massachusetts, 01605, United States
University of Michigan, Kellogg Eye Center
Ann Arbor, Michigan, 48105, United States
Kresge Eye Institute
Detroit, Michigan, 48201-1423, United States
Vitreo-Retinal Associates
Grand Rapids, Michigan, 49546, United States
Specialty Eye Institute
Jackson, Michigan, 49202, United States
Assoc Retinal Consultants PC
Royal Oak, Michigan, 48073, United States
Retina Consultants of Michigan
Southfield, Michigan, 48034, United States
Vitreoretinal Surgery
Edina, Minnesota, 55435, United States
Lifelong Vision Foundation
Chesterfield, Missouri, 63017, United States
Retina Consultants of Nevada
Las Vegas, Nevada, 89123, United States
Sierra Eye Associates
Reno, Nevada, 89502, United States
Retina Center of New Jersey
Bloomfield, New Jersey, 07003, United States
Mid Atlantic Retina - Wills Eye Hospital
Cherry Hill, New Jersey, 08034, United States
New Jersey Retina Research Foundation
Edison, New Jersey, 8820, United States
Delaware Valley Retina Assoc
Lawrenceville, New Jersey, 08648, United States
Retinal & Ophthalmic Cons PC
Northfield, New Jersey, 08225, United States
Retina Associates of NJ
Teaneck, New Jersey, 07666, United States
Lions Eye Institute
Albany, New York, 12208, United States
Long Is. Vitreoretinal Consult
Hauppauge, New York, 11788, United States
Opthalmic Consultants of LI
Lynbrook, New York, 11563, United States
New York Eye & Ear Infirmary
New York, New York, 10003, United States
Vitreous-Retina-Macula
New York, New York, 10022, United States
Retina Assoc of Western NY
Rochester, New York, 14620, United States
Retina Vit Surgeons/Central NY
Syracuse, New York, 13224, United States
West Carolina Retinal AssocPA
Asheville, North Carolina, 28803, United States
Char Eye Ear &Throat Assoc
Charlotte, North Carolina, 28210, United States
Duke University Eye Center; Vitreoretinal
Durham, North Carolina, 27710, United States
Wake Forest Baptist Health Eye Centre
Winston-Salem, North Carolina, 27157, United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242, United States
Retina Assoc of Cleveland Inc
Cleveland, Ohio, 44122, United States
Cleveland Clinic Foundation; Cole Eye Institute
Cleveland, Ohio, 44195, United States
OSU Eye Physicians & Surgeons
Columbus, Ohio, 43212, United States
Retina & Vitreous Center of Southern Oregon
Ashland, Oregon, 97520, United States
Retina Northwest
Portland, Oregon, 97221, United States
Oregon HSU; Casey Eye Institute
Portland, Oregon, 97239, United States
Retina Vitreous Consultants
Monroeville, Pennsylvania, 15146, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107, United States
Associates in Ophthalmology
West Mifflin, Pennsylvania, 15122, United States
Palmetto Retina Center
Florence, South Carolina, 29501, United States
Charleston Neuroscience Inst
Ladson, South Carolina, 29456, United States
Black Hills Eye Institute
Rapid City, South Dakota, 57701, United States
Southeastern Retina Associates Chattanooga
Chattanooga, Tennessee, 37421, United States
Charles Retina Institution
Germantown, Tennessee, 38138, United States
Tennessee Retina PC.
Nashville, Tennessee, 37203, United States
Retina Res Institute of Texas
Abilene, Texas, 79606, United States
Texas Retina Associates
Arlington, Texas, 76012, United States
Austin Retina Associates
Austin, Texas, 78705, United States
Retina Research Center
Austin, Texas, 78705, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
Retina Consultants of Houston
Houston, Texas, 77030, United States
Valley Retina Institute P.A.
McAllen, Texas, 78503, United States
Scott and White Hospital
Temple, Texas, 76504, United States
Retina Consultants of Houston
The Woodlands, Texas, 77384, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, 76087, United States
Retina Associates of Utah
Salt Lake City, Utah, 84107, United States
Univ of Virginia Ophthalmology
Charlottesville, Virginia, 22903, United States
Eye Surgeons of Richmond Inc. dba Virginia Eye Institute
Richmond, Virginia, 23226, United States
Retina Institute of Virginia
Richmond, Virginia, 23235, United States
Virginia Retina Center
Warrenton, Virginia, 20186, United States
Vitreoretinal Associates of Washington
Bellevue, Washington, 98004, United States
Retina Center Northwest
Silverdale, Washington, 98383, United States
Spokane Eye Clinical Research
Spokane, Washington, 99204, United States
West Virginia University Eye Institute
Morgantown, West Virginia, 26506, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Eyeclinic Albury Wodonga
Albury, New South Wales, 2640, Australia
Marsden Eye Research Centre
Parramatta, New South Wales, 2150, Australia
Save Sight Institute
Sydney, New South Wales, 2000, Australia
Sydney West Retina
Westmead, New South Wales, 2145, Australia
Vision Eye Institute Eastern
Box Hill, Victoria, 3128, Australia
Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria, 3002, Australia
Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde
Linz, 4021, Austria
Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie
Vienna, 1090, Austria
CHU Brugmann (Victor Horta)
Brussels, 1020, Belgium
UZ Leuven Sint Rafael
Leuven, 3000, Belgium
Institut De L'Oeil Des Laurentides
Boisbriand, Quebec, J7H 1S6, Canada
Glostrup Hospital, Øjenafdelingen, Forskningsafsnit Ø37
Glostrup Municipality, 2600, Denmark
Sjællands Universitetshospital, Roskilde; Øjenafdelingen
Roskilde, 4000, Denmark
Hopital Pellegrin; Ophtalmologie
Bordeaux, 33000, France
Chi De Creteil; Ophtalmologie
Créteil, 94010, France
Hôpital de La Croix Rousse
Lyon, 69004, France
Centre Monticelli Paradis d Ophtalmologie
Marseille, 13008, France
CHU Nantes - Hôtel Dieu; Ophthalmology
Nantes, 44093, France
Centre Odeon; Exploration Ophtalmologique
Paris, 75006, France
CHNO des Quinze Vingts; Ophtalmologie
Paris, 75012, France
Universitäts-Augenklinik Bonn
Bonn, 53127, Germany
Universitätsklinikum Köln; Augenklinik
Cologne, 50937, Germany
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
Freiburg im Breisgau, 79106, Germany
Medizinische Hochschule Hannover, Klinik für Augenheilkunde
Hanover, 30625, Germany
Universitätsklinik Heidelberg; Augenklinik
Heidelberg, 69120, Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik
Ludwigshafen, 67063, Germany
Universitätskliniikum Schleswig-Holstein, Campus Lübeck, Klinik für Augenheilkunde
Lübeck, 23538, Germany
LMU Klinikum der Universität, Augenklinik
München, 80336, Germany
Klinikum rechts der Isar der TU München; Augenklinik
München, 81675, Germany
Augenabteilung am St. Franziskus-Hospital
Münster, 48145, Germany
Universitätsklinikum Münster; Augenheilkunde
Münster, 48149, Germany
Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde
Regensburg, 93053, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
Semmelweis Egyetem AOK, Szemeszeti Klinika
Budapest, 1083, Hungary
Budapest Retina Associates Kft.
Budapest, 1133, Hungary
Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR
Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
Debrecem, 4032, Hungary
Ganglion Medial Center
Pécs, 7621, Hungary
Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche
Rome, Lazio, 00133, Italy
UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA
Genoa, Liguria, 16132, Italy
Irccs Ospedale San Raffaele;U.O. Oculistica
Milan, Lombardy, 20132, Italy
ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)
Milan, Lombardy, 20157, Italy
A.S.L. to1 Presidio Ospedaliero Sperino Oftalmico
Turin, Piedmont, 10122, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica
Udine, Veneto, 33100, Italy
Leids Universitair Medisch Centrum
Leiden, 2300 RC, Netherlands
TG Laser Oftalmica
Lima, 27, Peru
OFTALMIKA Sp. z o.o
Bydgoszcz, 85-631, Poland
Szpital Specjalistyczny nr 1; Oddzial Okulistyki
Bytom, 41-902, Poland
Optimum Profesorskie Centrum Okulistyki
Gdansk, 80-809, Poland
Gabinet Okulistyczny Prof Edward Wylegala
Katowice, 40-594, Poland
SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej
Krakow, 31-501, Poland
Klinika Okulistyczna Jasne Błonia
Lodz, 91-134, Poland
Uniwersytecki Szpital Kliniczny; Klinika Okulistyki
Wroclaw, 50-556, Poland
AIBILI - Association for Innovation and Biomedical Research on Light
Coimbra, 3000-548, Portugal
Espaco Medico Coimbra
Coimbra, 3030-163, Portugal
Hospital de Santa Maria; Servico de Oftalmologia
Lisbon, 1649-035, Portugal
Nemocnica sv. Michala, a.s.
Bratislava, 81108, Slovakia
Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda Ocna klinika SZU a UNB
Bratislava, 851 07, Slovakia
Fakultna nemocnica Trencin Ocna klinika
Trenčín, 911 71, Slovakia
Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie
Žilina, 012 07, Slovakia
Hospital Universitari de Bellvitge; Servicio de Oftalmologia
L'Hospitalet de Llobregat, Barcelona, 8907, Spain
Instituto Clinico Quirurgico de Oftalmologia - ICQO
Bilbao, Guipuzcoa, 48006, Spain
Instituto Oftalmologico Gomez Ulla
Santiago de Compostela, LA Coruña, 15706, Spain
Clinica Universitaria de Navarra; Servicio de Oftalmologia
Pamplona, Navarre, 31008, Spain
Hospital Perpetuo Socorro; Servicio de Oftalmología
Albacete, 02006, Spain
Institut de la Macula i la retina
Barcelona, 08022, Spain
Instituto de microcirugia ocular
Barcelona, 08035, Spain
VISSUM Madrid Santa Hortensia
Madrid, 28002, Spain
FISABIO. Fundación Oftalmologica del Mediterraneo
Valencia, 46015, Spain
Hospital Universitario Rio Hortega; Servicio de Oftalmologia
Valladolid, 47012, Spain
Inselspital Bern, Universitätsklinik für Augenheilkunde
Bern, 3010, Switzerland
Vista Klinik Binningen
Binningen, 4102, Switzerland
Stadtspital Triemli; Augenklinik
Zurich, 8063, Switzerland
Hacettepe University Medical Faculty
Ankara, 06100, Turkey (Türkiye)
Baskent University Ankara Hospital
Ankara, 06490, Turkey (Türkiye)
Royal Victoria Hospital
Belfast, BT12 6BA, United Kingdom
Bradford Royal Infirmary
Bradford, BD9 6RJ, United Kingdom
Bristol Eye Hospital
Bristol, BS1 2LX, United Kingdom
University Hospital of Wales
Cardiff, CF14 4XW, United Kingdom
Gloucestershire Hospitals NHS Foundation Trust
Gloucestershire, GL1 3NN, United Kingdom
Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre
Liverpool, L7 8XP, United Kingdom
Macular Treatment Centre; Royal Eye Hospital
Manchester, M13 9WL, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
The Royal Wolverhampton Hospitals NHS Trust
Wolverhampton, WV10 0QP, United Kingdom
The York Hospital
York, YO31 8HE, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated early by the Sponsor because the compound had demonstrated lack of efficacy. Thus, no participant in this study completed the full duration of treatment.
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2016
First Posted
April 20, 2016
Study Start
July 21, 2016
Primary Completion
January 31, 2018
Study Completion
January 31, 2018
Last Updated
March 6, 2019
Results First Posted
February 15, 2019
Record last verified: 2019-01