Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)

February 19, 2019 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

994

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Albury, New South Wales, Australia, 2640
        • Eyeclinic Albury Wodonga
      • Parramatta, New South Wales, Australia, 2150
        • Marsden Eye Research Centre
      • Sydney, New South Wales, Australia, 2000
        • Save Sight Institute
      • Westmead, New South Wales, Australia, 2145
        • Sydney West Retina
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Vision Eye Institute Eastern
      • East Melbourne, Victoria, Australia, 3002
        • Royal Victorian Eye and Ear Hospital
  • Austria
      • Linz, Austria, 4021
        • Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde
      • Wien, Austria, 1090
        • Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie
  • Belgium
      • Bruxelles, Belgium, 1020
        • CHU Brugmann (Victor Horta)
      • Leuven, Belgium, 3000
        • UZ Leuven Sint Rafael
  • Canada
    • Quebec
      • Boisbriand, Quebec, Canada, J7H 1S6
        • Institut De L'Oeil Des Laurentides
  • Denmark
      • Glostrup, Denmark, 2600
        • Glostrup Hospital, Øjenafdelingen, Forskningsafsnit Ø37
      • Roskilde, Denmark, 4000
        • Sjællands Universitetshospital, Roskilde; Øjenafdelingen
  • France
      • Bordeaux, France, 33000
        • Hopital Pellegrin; Ophtalmologie
      • Creteil, France, 94010
        • Chi De Creteil; Ophtalmologie
      • Lyon, France, 69004
        • Hopital de la croix rousse
      • Marseille, France, 13008
        • Centre Monticelli Paradis d Ophtalmologie
      • Nantes, France, 44093
        • CHU Nantes - Hôtel Dieu; Ophthalmology
      • Paris, France, 75006
        • Centre Odeon; Exploration Ophtalmologique
      • Paris, France, 75012
        • CHNO des Quinze Vingts; Ophtalmologie
  • Germany
      • Bonn, Germany, 53127
        • Universitäts-Augenklinik Bonn
      • Freiburg, Germany, 79106
        • Universitätsklinikum Freiburg, Klinik für Augenheilkunde
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover, Klinik für Augenheilkunde
      • Heidelberg, Germany, 69120
        • Universitätsklinik Heidelberg; Augenklinik
      • Köln, Germany, 50937
        • Universitätsklinikum Köln; Augenklinik
      • Ludwigshafen, Germany, 67063
        • Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik
      • Lübeck, Germany, 23538
        • Universitätskliniikum Schleswig-Holstein, Campus Lübeck, Klinik für Augenheilkunde
      • München, Germany, 80336
        • LMU Klinikum der Universitat, Augenklinik
      • München, Germany, 81675
        • Klinikum rechts der Isar der TU München; Augenklinik
      • Münster, Germany, 48145
        • Augenabteilung am St. Franziskus-Hospital
      • Münster, Germany, 48149
        • Universitätsklinikum Münster; Augenheilkunde
      • Regensburg, Germany, 93053
        • Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde
      • Tuebingen, Germany, 72076
        • Universitätsklinikum Tübingen
  • Hungary
      • Budapest, Hungary, 1133
        • Budapest Retina Associates Kft.
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem AOK, Szemeszeti Klinika
      • Budapest, Hungary
        • Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR
      • Debrecem, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
      • Pecs, Hungary, 7621
        • Ganglion Medial Center
  • Italy
    • Lazio
      • Roma, Lazio, Italy, 00133
        • Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche
    • Liguria
      • Genova, Liguria, Italy, 16132
        • UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA
    • Lombardia
      • Milano, Lombardia, Italy, 20157
        • ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)
      • Milano, Lombardia, Italy, 20132
        • Irccs Ospedale San Raffaele;U.O. Oculistica
    • Piemonte
      • Torino, Piemonte, Italy, 10122
        • A.S.L. to1 Presidio Ospedaliero Sperino Oftalmico
    • Veneto
      • Udine, Veneto, Italy, 33100
        • A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica
  • Netherlands
      • Leiden, Netherlands, 2300 RC
        • Leids Universitair Medisch Centrum
  • Peru
      • Lima, Peru, 27
        • TG Laser Oftalmica
  • Poland
      • Bydgoszcz, Poland, 85-631
        • OFTALMIKA Sp. z o.o
      • Bytom, Poland, 41-902
        • Szpital Specjalistyczny nr 1; Oddzial Okulistyki
      • Gdańsk, Poland, 80-809
        • Optimum Profesorskie Centrum Okulistyki
      • Katowice, Poland, 40-594
        • Gabinet Okulistyczny Prof Edward Wylegala
      • Krakow, Poland, 31-501
        • SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej
      • Wrocław, Poland, 50-556
        • Uniwersytecki Szpital Kliniczny; Klinika Okulistyki
      • Łódź, Poland, 91-134
        • Klinika Okulistyczna Jasne Błonia
  • Portugal
      • Coimbra, Portugal, 3030-163
        • Espaco Medico Coimbra
      • Coimbra, Portugal, 3000-548
        • AIBILI - Association for Innovation and Biomedical Research on Light
      • Lisboa, Portugal, 1649-035
        • Hospital de Santa Maria; Servico de Oftalmologia
  • Slovakia
      • Bratislava, Slovakia, 81108
        • Nemocnica sv. Michala, a.s.
      • Bratislava, Slovakia, 851 07
        • Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda Ocna klinika SZU a UNB
      • Trencin, Slovakia, 911 71
        • Fakultna nemocnica Trencin Ocna klinika
      • Zilina, Slovakia, 012 07
        • Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie
  • Spain
      • Albacete, Spain, 02006
        • Hospital Perpetuo Socorro; Servicio de Oftalmología
      • Barcelona, Spain, 08022
        • Institut de la Macula i la retina
      • Barcelona, Spain, 08035
        • Instituto de Microcirugia Ocular
      • Madrid, Spain, 28002
        • VISSUM Madrid Santa Hortensia
      • Valencia, Spain, 46015
        • FISABIO. Fundación Oftalmologica del Mediterraneo
      • Valladolid, Spain, 47012
        • Hospital Universitario Rio Hortega; Servicio de Oftalmologia
    • Barcelona
      • Hospitalet De Llobregat, Barcelona, Spain, 8907
        • Hospital Universitari de Bellvitge; Servicio de Oftalmologia
    • Guipuzcoa
      • Bilbao, Guipuzcoa, Spain, 48006
        • Instituto Clinico Quirurgico de Oftalmologia - ICQO
    • LA Coruña
      • Santiago de Compostela, LA Coruña, Spain, 15706
        • Instituto Oftalmologico Gomez Ulla
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universitaria de Navarra; Servicio de Oftalmologia
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital Bern, Universitätsklinik für Augenheilkunde
      • Binningen, Switzerland, 4102
        • Vista Klinik Binningen
      • Zürich, Switzerland, 8063
        • Stadtspital Triemli; Augenklinik
  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University Medical Faculty
      • Ankara, Turkey, 06490
        • Baskent University Ankara Hospital
  • United Kingdom
      • Belfast, United Kingdom, BT12 6BA
        • Royal Victoria Hospital
      • Bradford, United Kingdom, BD9 6RJ
        • Bradford Royal Infirmary
      • Bristol, United Kingdom, BS1 2LX
        • Bristol Eye Hospital
      • Cardiff, United Kingdom, CF14 4XW
        • University Hospital of Wales
      • Gloucestershire, United Kingdom, GL1 3NN
        • Gloucestershire Hospitals NHS Foundation Trust
      • Liverpool, United Kingdom, L7 8XP
        • Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre
      • Manchester, United Kingdom, M13 9WL
        • Macular Treatment Centre; Royal Eye Hospital
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Wolverhampton, United Kingdom, WV10 0QP
        • The Royal Wolverhampton Hospitals NHS Trust
      • York, United Kingdom, YO31 8HE
        • The York Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Uni of Alabama At Birmingham Clinical Research Unit
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Retinal Research Institute, LLC
      • Phoenix, Arizona, United States, 85020
        • Associated Retina Consultants
      • Tucson, Arizona, United States, 85704
        • Retina Centers P.C.
      • Tucson, Arizona, United States, 85750
        • Retina Associates Southwest PC
    • California
      • Bakersfield, California, United States, 93309
        • California Retina Consultants
      • Beverly Hills, California, United States, 90211
        • Retina-Vitreous Associates Medical Group
      • Fullerton, California, United States, 92835
        • Retina Consultants of Orange County
      • La Jolla, California, United States, 92093-0946
        • UCSD Shiley Eye Center
      • Los Angeles, California, United States, 90095-7000
        • Jules Stein Eye Institute/ UCLA
      • Mountain View, California, United States, 94040
        • N CA Retina Vitreous Assoc
      • Oakland, California, United States, 94609
        • East Bay Retina Consultants
      • Palm Desert, California, United States, 92211
        • Southern CA Desert Retina Cons
      • Palo Alto, California, United States, 94303
        • Byers Eye Insitute at Stanford
      • Poway, California, United States, 92064
        • Retina Consultants, San Diego
      • Sacramento, California, United States, 95817
        • University of California, Davis, Eye Center
      • Sacramento, California, United States, 95841
        • Retinal Consultants Med Group
      • San Francisco, California, United States, 94107
        • W Coast Retina Med Group Inc
      • San Francisco, California, United States, 94143
        • UCSF Comprehensive Cancer Ctr; Ophthalmology
      • Santa Ana, California, United States, 92705
        • Orange County Retina Med Group
      • Santa Barbara, California, United States, 93103
        • California Retina Consultants
      • Walnut Creek, California, United States, 94598
        • Bay Area Retina Associates
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Retina Consultants of Southern
      • Golden, Colorado, United States, 80201
        • Colorado Retina Associates, PC
    • Connecticut
      • New London, Connecticut, United States, 06320
        • Retina Group of New England
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Florida Eye Microsurgical Inst
      • Fort Lauderdale, Florida, United States, 33308
        • Retina Group of Florida
      • Fort Myers, Florida, United States, 33912
        • National Ophthalmic Research Institute
      • Fort Myers, Florida, United States, 33907
        • Retina Health Center
      • Melbourne, Florida, United States, 32901
        • Florida Eye Associates
      • Naples, Florida, United States, 34103
        • Bascom Palmer Eye Institute
      • Palm Beach Gardens, Florida, United States, 33410
        • Retina Care Specialists
      • Palm Beach Gardens, Florida, United States, 33418
        • Bascom Palmer Eye Institute
      • Pensacola, Florida, United States, 32503
        • Retina Specialty Institute
      • Plantation, Florida, United States, 33324
        • Fort Lauderdale Eye Institute
      • Saint Petersburg, Florida, United States, 33711
        • Retina Vitreous Assoc of FL
      • Tallahassee, Florida, United States, 32308
        • Southern Vitreoretinal Assoc
      • Tampa, Florida, United States, 33612
        • University of South Florida
      • Tampa, Florida, United States, 33609
        • Retina Associates of Florida, LLC
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Southeast Retina Center
      • Marietta, Georgia, United States, 30060
        • Georgia Retina PC
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • Retina Consultants Of Hawaii
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Midwest Eye Institute Northside
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Wolfe Eye Clinic
    • Kansas
      • Shawnee Mission, Kansas, United States, 66204
        • Retina Associates
      • Wichita, Kansas, United States, 67214
        • Vitreo Retinal Consultants
    • Kentucky
      • Lexington, Kentucky, United States, 02421
        • Lahey Clinic Med Ctr
      • Lexington, Kentucky, United States, 40509
        • Retina Associates of Kentucky
      • Paducah, Kentucky, United States, 42001
        • Paducah Retinal Center
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Eye Center
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • The Retina Care Center
      • Baltimore, Maryland, United States, 21287
        • Wilmer Eye Institute
      • Chevy Chase, Maryland, United States, 20815
        • Retina Group of Washington
      • Towson, Maryland, United States, 21204
        • Retina Specialists
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center Research
      • Boston, Massachusetts, United States, 02114
        • Mass Eye and Ear Infirmary
      • Worcester, Massachusetts, United States, 01605
        • Vitreo-Retinal Associates, PC
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • University of Michigan, Kellogg Eye Center
      • Detroit, Michigan, United States, 48201-1423
        • Kresge Eye Institute
      • Grand Rapids, Michigan, United States, 49546
        • Vitreo-Retinal Associates
      • Jackson, Michigan, United States, 49202
        • Specialty Eye Institute
      • Royal Oak, Michigan, United States, 48073
        • Assoc Retinal Consultants PC
      • Southfield, Michigan, United States, 48034
        • Retina Consultants of Michigan
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Vitreoretinal Surgery
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Lifelong Vision Foundation
    • Nevada
      • Las Vegas, Nevada, United States, 89123
        • Retina Consultants of Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Eye Associates
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Retina Center of New Jersey
      • Cherry Hill, New Jersey, United States, 08034
        • Mid Atlantic Retina - Wills Eye Hospital
      • Edison, New Jersey, United States, 8820
        • New Jersey Retina Research Foundation
      • Lawrenceville, New Jersey, United States, 08648
        • Delaware Valley Retina Assoc
      • Northfield, New Jersey, United States, 08225
        • Retinal & Ophthalmic Cons PC
      • Teaneck, New Jersey, United States, 07666
        • Retina Associates of NJ
    • New York
      • Albany, New York, United States, 12208
        • Lions Eye Institute
      • Hauppauge, New York, United States, 11788
        • Long Is. Vitreoretinal Consult
      • Lynbrook, New York, United States, 11563
        • Opthalmic Consultants of LI
      • New York, New York, United States, 10003
        • New York Eye & Ear Infirmary
      • New York, New York, United States, 10022
        • Vitreous-Retina-Macula
      • Rochester, New York, United States, 14620
        • Retina Assoc of Western NY
      • Syracuse, New York, United States, 13224
        • Retina Vit Surgeons/Central NY
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • West Carolina Retinal AssocPA
      • Charlotte, North Carolina, United States, 28210
        • Char Eye Ear &Throat Assoc
      • Durham, North Carolina, United States, 27710
        • Duke University Eye Center; Vitreoretinal
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health Eye Centre
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Cincinnati Eye Institute
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation; Cole Eye Institute
      • Cleveland, Ohio, United States, 44122
        • Retina Assoc of Cleveland Inc
      • Columbus, Ohio, United States, 43212
        • OSU Eye Physicians & Surgeons
    • Oregon
      • Ashland, Oregon, United States, 97520
        • Retina & Vitreous Center of Southern Oregon
      • Portland, Oregon, United States, 97221
        • Retina Northwest
      • Portland, Oregon, United States, 97239
        • Oregon HSU; Casey Eye Institute
    • Pennsylvania
      • Monroeville, Pennsylvania, United States, 15146
        • Retina Vitreous Consultants
      • Philadelphia, Pennsylvania, United States, 19107
        • Mid Atlantic Retina
      • West Mifflin, Pennsylvania, United States, 15122
        • Associates in Ophthalmology
    • South Carolina
      • Florence, South Carolina, United States, 29501
        • Palmetto Retina Center
      • Ladson, South Carolina, United States, 29456
        • Charleston Neuroscience Inst
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Eye Institute
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Southeastern Retina Associates Chattanooga
      • Germantown, Tennessee, United States, 38138
        • Charles Retina Institution
      • Nashville, Tennessee, United States, 37203
        • Tennessee Retina PC.
    • Texas
      • Abilene, Texas, United States, 79606
        • Retina Res Institute of Texas
      • Arlington, Texas, United States, 76012
        • Texas Retina Associates
      • Austin, Texas, United States, 78705
        • Austin Retina Associates
      • Austin, Texas, United States, 78705
        • Retina Research Center
      • Dallas, Texas, United States, 75231
        • Texas Retina Associates
      • Houston, Texas, United States, 77030
        • Retina Consultants of Houston
      • McAllen, Texas, United States, 78503
        • Valley Retina Institute P.A.
      • Temple, Texas, United States, 76504
        • Scott and White Hospital
      • The Woodlands, Texas, United States, 77384
        • Retina Consultants of Houston
      • Willow Park, Texas, United States, 76087
        • Strategic Clinical Research Group, LLC
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Retina Associates of Utah
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Univ of Virginia Ophthalmology
      • Richmond, Virginia, United States, 23226
        • Eye Surgeons of Richmond Inc. dba Virginia Eye Institute
      • Richmond, Virginia, United States, 23235
        • Retina Institute of Virginia
      • Warrenton, Virginia, United States, 20186
        • Virginia Retina Center
    • Washington
      • Bellevue, Washington, United States, 98004
        • Vitreoretinal Associates of Washington
      • Silverdale, Washington, United States, 98383
        • Retina Center Northwest
      • Spokane, Washington, United States, 99204
        • Spokane Eye Clinical Research
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Eye Institute
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lampalizumab Every 4 Weeks
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.
Drug: Lampalizumab
Lampalizumab 10 mg will be administered every 4 or 6 weeks according to the frequency given during participation in the parent study.
Experimental: Lampalizumab Every 6 Weeks
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.
Drug: Lampalizumab
Lampalizumab 10 mg will be administered every 4 or 6 weeks according to the frequency given during participation in the parent study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Ocular Adverse Events (AEs) by Severity
Time Frame: 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.
Up to approximately one year
Percentage of Participants With Systemic (Non-Ocular) AEs by Severity
Time Frame: 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.
Up to approximately one year
Percentage of Participants With Anti-Lampalizumab Antibodies
Time Frame: 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.
Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2016

Primary Completion (Actual)

January 31, 2018

Study Completion (Actual)

January 31, 2018

Study Registration Dates

First Submitted

April 18, 2016

First Submitted That Met QC Criteria

April 18, 2016

First Posted (Estimate)

April 20, 2016

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

February 19, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GX30191
  • 2016-000423-13 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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