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Trial record 3 of 5 for:    lampalizumab

A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (SPECTRI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02247531
First received: July 15, 2014
Last updated: July 20, 2017
Last verified: July 2017
  Purpose
This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Condition Intervention Phase
Geographic Atrophy Drug: Lampalizumab Other: Sham Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Assess the Efficacy and Safety of Lampalizumab Administered Intravitreally to Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change from Baseline in GA Area as Assessed by Fundus Autofluorescence (FAF) at Week 48 [ Time Frame: Baseline to Week 48 ]

Secondary Outcome Measures:
  • Change in Number of Scotomatous Points Assessed by Mesopic Microperimetry [ Time Frame: Baseline to Week 96 ]
  • Change in Macular Sensitivity Assessed by Mesopic Microperimetry [ Time Frame: Baseline to Week 96 ]
  • Change in GA Area as Assessed by FAF at Week 96 [ Time Frame: Baseline to Week 96 ]
  • Change in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart [ Time Frame: Baseline to Week 96 ]
  • Change in BCVA Score Assessed by ETDRS Chart Under Low Luminance Conditions [ Time Frame: Baseline to Week 96 ]
  • Change in Binocular Reading Speed Assessed by Minnesota Low-Vision Reading Test (MNRead) Charts or Radner Reading Charts [ Time Frame: Baseline to Week 96 ]
  • Change in Binocular Critical Print Size Assessed by MNRead Charts or Radner Reading Charts [ Time Frame: Baseline to Week 96 ]
  • Change in National Eye Institute Visual Functioning Questionnaire 25-Item (NEI VFQ-25) Version Composite Score [ Time Frame: Baseline to Week 96 ]
  • Change in NEI VFQ-25 Near Activity Subscale Score [ Time Frame: Baseline to Week 96 ]
  • Change in NEI VFQ-25 Distance Activity Subscale Score [ Time Frame: Baseline to Week 96 ]
  • Change in Functional Reading Independence (FRI) Index [ Time Frame: Baseline to Week 96 ]
  • Serum Concentration of Lampalizumab [ Time Frame: Predose (Day 1, 0 hours) to Week 96 ]
  • Percentage of Participants With Less Than (<) 15 Letters Loss in BCVA Score Compared to Baseline as Assessed by ETDRS Chart [ Time Frame: Baseline to Week 96 ]
  • Percentage of Participants With <15 Letters Loss in BCVA Score Compared to Baseline as Assessed by ETDRS Chart Under Low Luminance Conditions [ Time Frame: Baseline to Week 96 ]
  • Number of Participants With Positive Anti-Therapeutic Antibodies (ATAs) Against Lampalizumab [ Time Frame: Predose (Day 1, 0 hours) to Week 96 ]

Estimated Enrollment: 936
Actual Study Start Date: October 5, 2014
Estimated Study Completion Date: June 10, 2018
Primary Completion Date: July 10, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lampalizumab: Every 4 Weeks (Q4W)
Lampalizumab 10-milligram (mg) injections administered intravitreally during the 2-year treatment period.
Drug: Lampalizumab
10-mg dose of lampalizumab administered intravitreally.
Other Name: RO5490249
Experimental: Lampalizumab: Every 6 Weeks (Q6W)
Lampalizumab 10-mg injections administered intravitreally during the 2-year treatment period.
Drug: Lampalizumab
10-mg dose of lampalizumab administered intravitreally.
Other Name: RO5490249
Sham Comparator: Sham
Sham injections will be administered during the 2-year treatment period.
Other: Sham
A sham injection is a procedure that mimics an intravitreal injection of lampalizumab.

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants aged greater than or equal to (>/=) 50 years
  • Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in both eyes

Exclusion Criteria:

Ocular Exclusion Criteria (Study Eye):

  • History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
  • 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)

Ocular Exclusion Criteria (Both Eyes):

  • GA in either eye due to causes other than AMD
  • Previous treatment with eculizumab, lampalizumab, and/or fenretinide
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02247531

  Hide Study Locations
Locations
United States, Arizona
Associated Retina Consultants
Phoenix, Arizona, United States, 85020
Retina Associates Southwest PC
Tucson, Arizona, United States, 85750
United States, California
Retina Consultants of Orange County
Fullerton, California, United States, 92835
UCSD Shiley Eye Center
La Jolla, California, United States, 92093-0946
Jules Stein Eye Institute/ UCLA
Los Angeles, California, United States, 90095-7000
N CA Retina Vitreous Assoc
Mountain View, California, United States, 94040
Byers Eye Insitute at Stanford
Palo Alto, California, United States, 94303
Retina Consultants, San Diego
Poway, California, United States, 92064
University of California, Davis, Eye Center
Sacramento, California, United States, 95817
Retinal Consultants Med Group
Sacramento, California, United States, 95841
California Retina Consultants
Santa Barbara, California, United States, 93103
Bay Area Retina Associates
Walnut Creek, California, United States, 94598
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
Retina Consultants of Southern
Colorado Springs, Colorado, United States, 80909
Colorado Retina Associates, PC
Golden, Colorado, United States, 80201
United States, Connecticut
New England Retina Associates
Hamden, Connecticut, United States, 06518
Retina Group of New England
New London, Connecticut, United States, 06320
United States, Florida
Retina Group of Florida
Fort Lauderdale, Florida, United States, 33308
Retina Health Center
Fort Myers, Florida, United States, 33907
Bascom Palmer Eye Institute
Naples, Florida, United States, 34103
Retina Vitreous Assoc of FL
Saint Petersburg, Florida, United States, 33711
Southern Vitreoretinal Assoc
Tallahassee, Florida, United States, 32308
University of South Florida
Tampa, Florida, United States, 33612
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Iowa
Wolfe Eye Clinic
West Des Moines, Iowa, United States, 50266
United States, Kansas
Vitreo Retinal Consultants
Wichita, Kansas, United States, 67214
United States, Kentucky
Paducah Retinal Center
Paducah, Kentucky, United States, 42001
United States, Maryland
The Retina Care Center
Baltimore, Maryland, United States, 21209
Wilmer Eye Institute
Baltimore, Maryland, United States, 21287
Retina Group of Washington
Chevy Chase, Maryland, United States, 20815
Retina Specialists
Towson, Maryland, United States, 21204
United States, Massachusetts
Mass Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan, Kellogg Eye Center
Ann Arbor, Michigan, United States, 48105
Kresge Eye Institute
Detroit, Michigan, United States, 48201-1423
United States, Minnesota
Vitreoretinal Surgery
Edina, Minnesota, United States, 55435
United States, Missouri
Pepose Vision Institute
Chesterfield, Missouri, United States, 63017
United States, Nebraska
UNMC Truhlsen Eye Institute
Omaha, Nebraska, United States, 68105
United States, Nevada
Sierra Eye Associates
Reno, Nevada, United States, 89502
United States, New Jersey
Retinal & Ophthalmic Cons PC
Northfield, New Jersey, United States, 08225
Retina Associates of NJ
Teaneck, New Jersey, United States, 07666
United States, New York
New York Weil Cornell Med Ctr
New York, New York, United States, 10021
Vitreous-Retina-Macula
New York, New York, United States, 10022
Retina Assoc of Western NY
Rochester, New York, United States, 14620
United States, North Carolina
West Carolina Retinal AssocPA
Asheville, North Carolina, United States, 28803
Char Eye Ear &Throat Assoc
Charlotte, North Carolina, United States, 28210
Duke University Eye Center; Vitreoretinal
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati Eye Institute
Cincinnati, Ohio, United States, 45242
OSU Eye Physicians & Surgeons
Columbus, Ohio, United States, 43212
United States, Oregon
Retina & Vitreous Center of Southern Oregon
Ashland, Oregon, United States, 97520
Retina Northwest
Portland, Oregon, United States, 97210
Oregon HSU; Casey Eye Institute
Portland, Oregon, United States, 97239
United States, Pennsylvania
Mid Atlantic Retina
Philadelphia, Pennsylvania, United States, 19107
Mid-Atlantic Retina
Philadelphia, Pennsylvania, United States, 19107
Allegheny Ophthalmic & Orbital
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
MUSC Storm eye institute
Charleston, South Carolina, United States
Charleston Neuroscience Inst
Ladson, South Carolina, United States, 29456
Palmetto Retina Center
West Columbia, South Carolina, United States, 29169
United States, South Dakota
Black Hills Eye Institute
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Southeastern Retina Associates Chattanooga
Chattanooga, Tennessee, United States, 37421
Charles Retina Institution
Germantown, Tennessee, United States, 38138
United States, Texas
Retina Res Institute of Texas
Abilene, Texas, United States, 79606
Texas Retina Associates
Dallas, Texas, United States, 75231
Retina Consultants of Houston
Houston, Texas, United States, 77030
Scott and White Hospital
Temple, Texas, United States, 76504
Retina Consultants of Houston
The Woodlands, Texas, United States, 77384
United States, Virginia
Univ of Virginia Ophthalmology
Charlottesville, Virginia, United States, 22903
United States, Washington
Vitreoretinal Associates of Washington
Bellevue, Washington, United States, 98004
Argentina
Oftalmos
Capital Federal, Argentina, C1120AAN
Instituto de la Vision
Capital Federal, Argentina, C1122AAI
Hospital El Cruce
Florencio Varela, Argentina, B1888AAE
Australia, Queensland
Queensland Eye Institute
Brisbane, Queensland, Australia, 4101
Australia, South Australia
Adelaide Eye and Retina Centre
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Vision Eye Institute Eastern
Box Hill, Victoria, Australia, 3128
Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria, Australia, 3002
Australia, Western Australia
The Lions Eye Institute
Nedlands, Western Australia, Australia, 6009
Austria
Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie
Wien, Austria, 1090
Belgium
CHU Brugmann (Victor Horta)
Bruxelles, Belgium, 1020
UZ Leuven Sint Rafael
Leuven, Belgium, 3000
Denmark
Glostrup Hospital, Øjenafdelingen, Forskningsafsnit Ø37
Glostrup, Denmark, 2600
France
Hopital Pellegrin; Ophtalmologie
Bordeaux, France, 33000
CHU Bocage; Ophtalmologie
Dijon, France, 21079
Hopital de la croix rousse; Ophtalmologie
Lyon cedex, France, 69317
Centre Paradis Monticelli; Ophtalmologie
Marseille, France, 13008
Hopital Hotel Dieu Et Hme; Clinique Ophtalmologique
Nantes, France, 44093
CHNO des Quinze Vingts; Ophtalmologie
Paris, France, 75012
Germany
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
Freiburg, Germany, 79106
Universitätsklinik Heidelberg; Augenklinik
Heidelberg, Germany, 69120
Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik
Ludwigshafen, Germany, 67063
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik
Mainz, Germany, 55131
LMU Klinikum der Universität, Augenklinik
München, Germany, 80336
Klinikum rechts der Isar der TU München; Augenklinik
München, Germany, 81675
Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde
Regensburg, Germany, 93053
Universitätsklinikum Tübingen
Tuebingen, Germany, 72076
Hungary
Semmelweis Egyetem AOK, Szemeszeti Klinika
Budapest, Hungary, 1083
Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR
Budapest, Hungary
Ganglion Medial Center
Pecs, Hungary, 7621
Italy
UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA
Genova, Liguria, Italy, 16132
Irccs Ospedale San Raffaele;U.O. Oculistica
Milano, Lombardia, Italy, 20132
ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)
Milano, Lombardia, Italy, 20157
A.S.L. to1 Presidio Ospedaliero Sperino Oftalmico
Torino, Piemonte, Italy, 10122
Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica
Firenze, Toscana, Italy, 50134
A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica
Udine, Veneto, Italy, 33100
Mexico
Hospital Nuestra Señora de La Luz
Mexico City, Mexico, 06030
Hospital Universitario de Monterrey
Monterrey, Mexico, 64040
Instituto Mexicano de Oftalmologia I.A.P.
Querétaro, Mexico, 76090
Netherlands
Radboud University Nijmegen Medical Centre; Ophthalmology
Nijmegen, Netherlands, 6525 EX
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 CE
Peru
Mácula D&T
Lima, Peru, 27
TG Laser Oftalmica
Lima, Peru, 27
Centro de Investigacion Oftalmolaser
Lima, Peru, 33
Poland
OFTALMIKA Sp. z o.o
Bydgoszcz, Poland, 85-631
Szpital Specjalistyczny nr 1; Oddzial Okulistyki
Bytom, Poland, 41-902
Uniwersytecki Szpital Kliniczny; Klinika Okulistyki
Wrocław, Poland, 50-556
Klinika Okulistyczna Jasne Błonia
Łódź, Poland, 91-134
Portugal
AIBILI - Association for Innovation and Biomedical Research on Light
Coimbra, Portugal, 3000-548
Espaco Medico Coimbra
Coimbra, Portugal, 3030-163
Hospital de Santa Maria; Servico de Oftalmologia
Lisboa, Portugal, 1649-035
Hospital de Sao Joao; Servico de Oftalmologia
Porto, Portugal, 4200-319
Russian Federation
SAHI "Republic clinical ophthalmological hospial of Ministry of Heal of Tatarstan Republic"
Kazan, Russian Federation, 420012
FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences
Moscow, Russian Federation, 119435
St. Educ.Inst. of High Prof.Education "Samara State Medical University"; Chair of ophathalmology
Samara, Russian Federation, 443068
Slovakia
FNsP F. D. Roosevelta Banska Bystrica, II.Ocna klinika SZU
Banska Bystrica, Slovakia, 975 17
Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda Ocna klinika SZU a UNB
Bratislava, Slovakia, 851 07
Spain
Instituto Oftalmologico Gomez Ulla
Santiago de Compostela, La Coruña, Spain, 15706
Clinica Universitaria de Navarra; Servicio de Oftalmologia
Pamplona, Navarra, Spain, 31008
Hospital Perpetuo Socorro; Servicio de Oftalmología
Albacete, Spain, 02006
Instituto de microcirugia ocular
Barcelona, Spain, 08035
VISSUM Madrid Santa Hortensia
Madrid, Spain, 28002
Hospital Universitario Clínico San Carlos; Servicio de Oftalmologia
Madrid, Spain, 28040
Hospital Universitario la Fe: Servicio de Oftalmologia
Valencia, Spain, 46026
Sweden
St Eriks Eye Hospital
Stockholm, Sweden, SE-112 82
Switzerland
Inselspital Bern, Universitätsklinik für Augenheilkunde
Bern, Switzerland, 3010
Vista Klinik Binningen
Binningen, Switzerland, 4102
Turkey
Hacettepe University Medical Faculty; Department of Ophthalmology
Ankara, Turkey, 06100
Ankara University Medical Faculty; Department of Ophthalmology
Ankara, Turkey, 06340
Ankara Baskent University Medical Faculty; Department of Ophthalmology
Ankara, Turkey, 06490
Istanbul University Istanbul Medical Faculty; Department of Ophthalmology
Istanbul, Turkey, 34093
Ege University Medical Faculty; Department of Ophthalmology
Izmir, Turkey, 35100
Dokuz Eylul University Medical Faculty; Department of Ophthalmology
Izmir, Turkey, 35340
United Kingdom
Royal Victoria Hospital
Belfast, United Kingdom, BT12 6BA
Bradford Royal Infirmary
Bradford, United Kingdom, BD9 6RJ
Bristol Eye Hospital
Bristol, United Kingdom, BS1 2LX
University Hospital of Wales
Cardiff, United Kingdom, CF14 4XW
Gloucestershire Hospitals NHS Foundation Trust
Gloucestershire, United Kingdom, GL1 3NN
Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre
Liverpool, United Kingdom, L7 8XP
Moorfields Eye Hospital NHS Foundation Trust
London, United Kingdom, EC1V 2PD
Kings College Hospital
London, United Kingdom, SE5 9RS
Macular Treatment Centre; Royal Eye Hospital
Manchester, United Kingdom, M13 9WL
Hillingdon Hospital
Middx, United Kingdom, UB8 3NN
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE1 4LP
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
The Royal Wolverhampton Hospitals NHS Trust
Wolverhampton, United Kingdom, WV10 0QP
The York Hospital
York, United Kingdom, YO31 8HE
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02247531     History of Changes
Other Study ID Numbers: GX29185
2014-000106-35 ( EudraCT Number )
Study First Received: July 15, 2014
Last Updated: July 20, 2017

Additional relevant MeSH terms:
Macular Degeneration
Atrophy
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical
Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2017