Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)
- Registration Number
- NCT02745119
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 994
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lampalizumab Every 4 Weeks Lampalizumab Participants 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 Lampalizumab Participants 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Anti-Lampalizumab Antibodies Week 48 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.
Percentage of Participants With Ocular Adverse Events (AEs) by Severity Up to approximately one year 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.
Percentage of Participants With Systemic (Non-Ocular) AEs by Severity Up to approximately one year 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (204)
Retina Group of Florida
🇺🇸Fort Lauderdale, Florida, United States
Maine Eye Center
🇺🇸Portland, Maine, United States
Vitreo-Retinal Associates, PC
🇺🇸Worcester, Massachusetts, United States
Lifelong Vision Foundation
🇺🇸Chesterfield, Missouri, United States
OSU Eye Physicians & Surgeons
🇺🇸Columbus, Ohio, United States
Mid Atlantic Retina
🇺🇸Philadelphia, Pennsylvania, United States
Texas Retina Associates
🇺🇸Dallas, Texas, United States
Retina Consultants of Orange County
🇺🇸Fullerton, California, United States
Jules Stein Eye Institute/ UCLA
🇺🇸Los Angeles, California, United States
N CA Retina Vitreous Assoc
🇺🇸Mountain View, California, United States
Georgia Retina PC
🇺🇸Marietta, Georgia, United States
Retina Centers P.C.
🇺🇸Tucson, Arizona, United States
Retina Associates Southwest PC
🇺🇸Tucson, Arizona, United States
Bascom Palmer Eye Institute
🇺🇸Palm Beach Gardens, Florida, United States
Retina Vitreous Assoc of FL
🇺🇸Saint Petersburg, Florida, United States
Retina Consultants of Southern
🇺🇸Colorado Springs, Colorado, United States
Orange County Retina Med Group
🇺🇸Santa Ana, California, United States
Southeast Retina Center
🇺🇸Augusta, Georgia, United States
UCSD Shiley Eye Center
🇺🇸La Jolla, California, United States
Retina Center of New Jersey
🇺🇸Bloomfield, New Jersey, United States
Retina Health Center
🇺🇸Fort Myers, Florida, United States
Assoc Retinal Consultants PC
🇺🇸Royal Oak, Michigan, United States
Retina Consultants of Michigan
🇺🇸Southfield, Michigan, United States
Retina Associates of Kentucky
🇺🇸Lexington, Kentucky, United States
Retina Consultants of Hawaii
🇺🇸'Aiea, Hawaii, United States
Southern CA Desert Retina Cons
🇺🇸Palm Desert, California, United States
Retina Care Specialists
🇺🇸Palm Beach Gardens, Florida, United States
Retina Specialty Institute
🇺🇸Pensacola, Florida, United States
Wolfe Eye Clinic
🇺🇸West Des Moines, Iowa, United States
California Retina Consultants
🇺🇸Santa Barbara, California, United States
Fort Lauderdale Eye Institute
🇺🇸Plantation, Florida, United States
Southern Vitreoretinal Assoc
🇺🇸Tallahassee, Florida, United States
Retina-Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
Colorado Retina Associates, PC
🇺🇸Golden, Colorado, United States
Retina Specialists
🇺🇸Towson, Maryland, United States
National Ophthalmic Research Institute
🇺🇸Fort Myers, Florida, United States
Florida Eye Associates
🇺🇸Melbourne, Florida, United States
Vitreoretinal Surgery
🇺🇸Edina, Minnesota, United States
Mid Atlantic Retina - Wills Eye Hospital
🇺🇸Cherry Hill, New Jersey, United States
Retina Associates of NJ
🇺🇸Teaneck, New Jersey, United States
Retina Vitreous Consultants
🇺🇸Monroeville, Pennsylvania, United States
Charles Retina Institution
🇺🇸Germantown, Tennessee, United States
Cleveland Clinic Foundation; Cole Eye Institute
🇺🇸Cleveland, Ohio, United States
Palmetto Retina Center
🇺🇸Florence, South Carolina, United States
Centre Monticelli Paradis d Ophtalmologie
🇫🇷Marseille, France
Charleston Neuroscience Inst
🇺🇸Ladson, South Carolina, United States
SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej
🇵🇱Krakow, Poland
Inselspital Bern, Universitätsklinik für Augenheilkunde
🇨🇭Bern, Switzerland
Vista Klinik Binningen
🇨🇭Binningen, Switzerland
Tufts Medical Center Research
🇺🇸Boston, Massachusetts, United States
Mass Eye and Ear Infirmary
🇺🇸Boston, Massachusetts, United States
Midwest Eye Institute Northside
🇺🇸Indianapolis, Indiana, United States
Retina Consultants of Nevada
🇺🇸Las Vegas, Nevada, United States
Cincinnati Eye Institute
🇺🇸Cincinnati, Ohio, United States
Vitreo Retinal Consultants
🇺🇸Wichita, Kansas, United States
UCSF Comprehensive Cancer Ctr; Ophthalmology
🇺🇸San Francisco, California, United States
Associated Retina Consultants
🇺🇸Phoenix, Arizona, United States
Retinal Research Institute, LLC
🇺🇸Phoenix, Arizona, United States
Kresge Eye Institute
🇺🇸Detroit, Michigan, United States
Duke University Eye Center; Vitreoretinal
🇺🇸Durham, North Carolina, United States
Macular Treatment Centre; Royal Eye Hospital
🇬🇧Manchester, United Kingdom
East Bay Retina Consultants
🇺🇸Oakland, California, United States
Byers Eye Insitute at Stanford
🇺🇸Palo Alto, California, United States
W Coast Retina Med Group Inc
🇺🇸San Francisco, California, United States
Bay Area Retina Associates
🇺🇸Walnut Creek, California, United States
Retina Group of New England
🇺🇸New London, Connecticut, United States
Florida Eye Microsurgical Inst
🇺🇸Boynton Beach, Florida, United States
Retina Associates
🇺🇸Shawnee Mission, Kansas, United States
Lahey Clinic Med Ctr
🇺🇸Lexington, 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
Ganglion Medial Center
🇭🇺Pecs, Hungary
Ophthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
Vitreo-Retinal Associates
🇺🇸Grand Rapids, Michigan, United States
Specialty Eye Institute
🇺🇸Jackson, Michigan, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
New Jersey Retina Research Foundation
🇺🇸Edison, New Jersey, United States
Delaware Valley Retina Assoc
🇺🇸Lawrenceville, New Jersey, United States
Retinal & Ophthalmic Cons PC
🇺🇸Northfield, New Jersey, United States
Lions Eye Institute
🇺🇸Albany, New York, 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
Vitreous-Retina-Macula
🇺🇸New York, New York, United States
Retina Assoc of Western NY
🇺🇸Rochester, New York, United States
Sjællands Universitetshospital, Roskilde; Øjenafdelingen
🇩🇰Roskilde, Denmark
Retina Vit Surgeons/Central NY
🇺🇸Syracuse, New York, United States
Glostrup Hospital, Øjenafdelingen, Forskningsafsnit Ø37
🇩🇰Glostrup, Denmark
West Carolina Retinal AssocPA
🇺🇸Asheville, North Carolina, United States
Char Eye Ear &Throat Assoc
🇺🇸Charlotte, North Carolina, United States
Retina Assoc of Cleveland Inc
🇺🇸Cleveland, Ohio, United States
Retina & Vitreous Center of Southern Oregon
🇺🇸Ashland, Oregon, United States
Royal Victoria Infirmary
🇬🇧Newcastle upon Tyne, United Kingdom
Associates in Ophthalmology
🇺🇸West Mifflin, Pennsylvania, United States
Black Hills Eye Institute
🇺🇸Rapid City, South Dakota, United States
Southeastern Retina Associates Chattanooga
🇺🇸Chattanooga, Tennessee, United States
Tennessee Retina PC.
🇺🇸Nashville, Tennessee, United States
Retina Res Institute of Texas
🇺🇸Abilene, Texas, United States
Valley Retina Institute P.A.
🇺🇸McAllen, Texas, United States
Retina Consultants of Houston
🇺🇸The Woodlands, Texas, United States
Scott and White Hospital
🇺🇸Temple, Texas, United States
Strategic Clinical Research Group, LLC
🇺🇸Willow Park, Texas, United States
Retina Associates of Utah
🇺🇸Salt Lake City, Utah, United States
Univ of Virginia Ophthalmology
🇺🇸Charlottesville, Virginia, United States
Virginia Retina Center
🇺🇸Warrenton, Virginia, United States
Vitreoretinal Associates of Washington
🇺🇸Bellevue, Washington, 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
Save Sight Institute
🇦🇺Sydney, New South Wales, Australia
Eyeclinic Albury Wodonga
🇦🇺Albury, New South Wales, Australia
Marsden Eye Research Centre
🇦🇺Parramatta, New South Wales, Australia
Sydney West Retina
🇦🇺Westmead, New South Wales, Australia
Vision Eye Institute Eastern
🇦🇺Box Hill, Victoria, Australia
Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde
🇦🇹Linz, Austria
Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie
🇦🇹Wien, Austria
CHU Brugmann (Victor Horta)
🇧🇪Bruxelles, Belgium
UZ Leuven Sint Rafael
🇧🇪Leuven, Belgium
Institut De L'Oeil Des Laurentides
🇨🇦Boisbriand, Quebec, Canada
Hopital Pellegrin; Ophtalmologie
🇫🇷Bordeaux, France
Chi De Creteil; Ophtalmologie
🇫🇷Creteil, France
Hôpital de La Croix Rousse
🇫🇷Lyon, France
CHU Nantes - Hôtel Dieu; Ophthalmology
🇫🇷Nantes, France
Centre Odeon; Exploration Ophtalmologique
🇫🇷Paris, France
CHNO des Quinze Vingts; Ophtalmologie
🇫🇷Paris, France
Universitäts-Augenklinik Bonn
🇩🇪Bonn, Germany
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
🇩🇪Freiburg, Germany
Medizinische Hochschule Hannover, Klinik für Augenheilkunde
🇩🇪Hannover, Germany
Universitätsklinik Heidelberg; Augenklinik
🇩🇪Heidelberg, Germany
Universitätsklinikum Köln; Augenklinik
🇩🇪Köln, Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik
🇩🇪Ludwigshafen, Germany
Universitätskliniikum Schleswig-Holstein, Campus Lübeck, Klinik für Augenheilkunde
🇩🇪Lübeck, Germany
LMU Klinikum der Universität, Augenklinik
🇩🇪München, Germany
Klinikum rechts der Isar der TU München; Augenklinik
🇩🇪München, Germany
Augenabteilung am St. Franziskus-Hospital
🇩🇪Münster, Germany
Universitätsklinikum Münster; Augenheilkunde
🇩🇪Münster, Germany
Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde
🇩🇪Regensburg, Germany
Universitätsklinikum Tübingen
🇩🇪Tuebingen, Germany
Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
🇭🇺Debrecem, Hungary
Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche
🇮🇹Roma, Lazio, Italy
Irccs Ospedale San Raffaele;U.O. Oculistica
🇮🇹Milano, Lombardia, Italy
A.S.L. to1 Presidio Ospedaliero Sperino Oftalmico
🇮🇹Torino, Piemonte, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica
🇮🇹Udine, Veneto, Italy
Leids Universitair Medisch Centrum
🇳🇱Leiden, Netherlands
TG Laser Oftalmica
🇵🇪Lima, Peru
OFTALMIKA Sp. z o.o
🇵🇱Bydgoszcz, Poland
Gabinet Okulistyczny Prof Edward Wylegala
🇵🇱Katowice, Poland
Szpital Specjalistyczny nr 1; Oddzial Okulistyki
🇵🇱Bytom, Poland
Uniwersytecki Szpital Kliniczny; Klinika Okulistyki
🇵🇱Wrocław, Poland
AIBILI - Association for Innovation and Biomedical Research on Light
🇵🇹Coimbra, Portugal
Klinika Okulistyczna Jasne Błonia
🇵🇱Łódź, Poland
Espaco Medico Coimbra
🇵🇹Coimbra, Portugal
Hospital Universitari de Bellvitge; Servicio de Oftalmologia
🇪🇸Hospitalet De Llobregat, Barcelona, Spain
Instituto Clinico Quirurgico de Oftalmologia - ICQO
🇪🇸Bilbao, Guipuzcoa, Spain
Clinica Universitaria de Navarra; Servicio de Oftalmologia
🇪🇸Pamplona, Navarra, Spain
Instituto Oftalmologico Gomez Ulla
🇪🇸Santiago de Compostela, LA Coruña, Spain
Hospital Perpetuo Socorro; Servicio de Oftalmología
🇪🇸Albacete, Spain
Institut de la Macula i la retina
🇪🇸Barcelona, Spain
Instituto de microcirugia ocular
🇪🇸Barcelona, Spain
The Royal Wolverhampton Hospitals NHS Trust
🇬🇧Wolverhampton, United Kingdom
VISSUM Madrid Santa Hortensia
🇪🇸Madrid, Spain
FISABIO. Fundación Oftalmologica del Mediterraneo
🇪🇸Valencia, Spain
Hospital Universitario Rio Hortega; Servicio de Oftalmologia
🇪🇸Valladolid, Spain
Stadtspital Triemli; Augenklinik
🇨🇭Zürich, Switzerland
Hacettepe University Medical Faculty
🇹🇷Ankara, Turkey
Southampton General Hospital
🇬🇧Southampton, United Kingdom
Baskent University Ankara Hospital
🇹🇷Ankara, Turkey
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
Uni of Alabama At Birmingham Clinical Research Unit
🇺🇸Birmingham, Alabama, United States
Retina Northwest
🇺🇸Portland, Oregon, United States
Oregon HSU; Casey Eye Institute
🇺🇸Portland, Oregon, United States
ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)
🇮🇹Milano, Lombardia, Italy
Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre
🇬🇧Liverpool, United Kingdom
The York Hospital
🇬🇧York, United Kingdom
Budapest Retina Associates Kft.
🇭🇺Budapest, Hungary
Royal Victorian Eye and Ear Hospital
🇦🇺East Melbourne, Victoria, Australia
UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA
🇮🇹Genova, Liguria, Italy
Semmelweis Egyetem AOK, Szemeszeti Klinika
🇭🇺Budapest, Hungary
Nemocnica sv. Michala, a.s.
🇸🇰Bratislava, Slovakia
Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie
🇸🇰Zilina, Slovakia
Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR
🇭🇺Budapest, Hungary
Hospital de Santa Maria; Servico de Oftalmologia
🇵🇹Lisboa, Portugal
Optimum Profesorskie Centrum Okulistyki
🇵🇱Gdańsk, Poland
Fakultna nemocnica Trencin Ocna klinika
🇸🇰Trencin, Slovakia
Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda Ocna klinika SZU a UNB
🇸🇰Bratislava, Slovakia
Retina Associates of Florida, LLC
🇺🇸Tampa, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Retina Consultants, San Diego
🇺🇸Poway, California, United States
Paducah Retinal Center
🇺🇸Paducah, Kentucky, United States
University of California, Davis, Eye Center
🇺🇸Sacramento, California, United States
Retinal Consultants Med Group
🇺🇸Sacramento, California, United States
University of Michigan, Kellogg Eye Center
🇺🇸Ann Arbor, Michigan, United States
Wake Forest Baptist Health Eye Centre
🇺🇸Winston-Salem, North Carolina, United States
Austin Retina Associates
🇺🇸Austin, Texas, United States
Eye Surgeons of Richmond Inc. dba Virginia Eye Institute
🇺🇸Richmond, Virginia, United States
Retina Institute of Virginia
🇺🇸Richmond, Virginia, United States
Retina Research Center
🇺🇸Austin, Texas, United States