Clinical trial NCT02745119: Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Geographic Atrophy
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-04-20
Enrollment: 994
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

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