Clinical trial NCT02247531: A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Geographic Atrophy
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-09-25
Enrollment: 975
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* Participants aged greater than or equal to (\>/=) 50 years
* Well demarcated area(s) of Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (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

Primary outcomes:
measure: Change From Baseline in Geographic Atropy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48
timeFrame: Baseline, Week 48
measure: Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48
timeFrame: Baseline, Week 48
Secondary outcomes:
measure: Change From Baseline in Number of Absolute Scotomatous Points Assessed by Mesopic Microperimetry at Week 48
timeFrame: Baseline, Week 48
measure: Change From Baseline in Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48
timeFrame: Baseline, Week 48
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Week 48
timeFrame: Baseline, Week 48
measure: Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week 48
timeFrame: Week 48
measure: Change From Baseline in Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions at Week 48
timeFrame: Baseline, Week 48
measure: Percentage of Participants With Less Than 15 Letters Loss From Baseline in LLVA Score at Week 48
timeFrame: Week 48
measure: Change From Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Charts or Radner Reading Charts at Week 48
timeFrame: Baseline, Week 48
measure: Change From Baseline in Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts at Week 48
timeFrame: Baseline, Week 48
measure: Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score at Week 48
timeFrame: Baseline, Week 48
measure: Change From Baseline in NEI VFQ-25 Near Activity Subscale Score at Week 48
timeFrame: Baseline, Week 48
measure: Change From Baseline in NEI VFQ-25 Distance Activity Subscale Score at Week 48
timeFrame: Baseline, Week 48
measure: Change From Baseline in Mean Functional Reading Independence (FRI) Index at Week 48
timeFrame: Baseline, Week 48
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Associated Retina Consultants
state: Arizona
city: Tucson
country: United States
facility: Retina Associates Southwest PC
state: Arizona
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: 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: 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: Hamden
country: United States
facility: New England Retina Associates
state: Connecticut
city: Waterford
country: United States
facility: Retina Group of New England
state: Connecticut
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: Naples
country: United States
facility: Bascom Palmer 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: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: West Des Moines
country: United States
facility: Wolfe Eye Clinic
state: Iowa
city: Wichita
country: United States
facility: Vitreo Retinal Consultants
state: Kansas
city: Paducah
country: United States
facility: Paducah Retinal Center
state: Kentucky
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: Mass Eye and Ear Infirmary
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: Edina
country: United States
facility: Vitreoretinal Surgery
state: Minnesota
city: Chesterfield
country: United States
facility: Midwest Vision Research Foundation
state: Missouri
city: Omaha
country: United States
facility: UNMC Truhlsen Eye Institute
state: Nebraska
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Cherry Hill
country: United States
facility: Mid Atlantic Retina - Wills Eye Hospital
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: New York
country: United States
facility: New York Weil Cornell Med Ctr
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: Asheville
country: United States
facility: Western Carolina Retinal Associate PA
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: Cincinnati
country: United States
facility: Cincinnati 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: Philadelphia
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Ophthalmic & Orbital
state: Pennsylvania
city: Charleston
country: United States
facility: MUSC Storm eye institute
state: South Carolina
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: Abilene
country: United States
facility: Retina Res Institute of Texas
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: 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: Charlottesville
country: United States
facility: Univ of Virginia Ophthalmology
state: Virginia
city: Bellevue
country: United States
facility: Vitreoretinal Associates of Washington
state: Washington
city: Capital Federal
country: Argentina
facility: Oftalmos
city: Capital Federal
country: Argentina
facility: Instituto de la Vision
city: Florencio Varela
country: Argentina
facility: Hospital El Cruce
city: Brisbane
country: Australia
facility: Queensland Eye Institute
state: Queensland
city: Adelaide
country: Australia
facility: Adelaide Eye and Retina Centre
state: South Australia
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: Nedlands
country: Australia
facility: The Lions Eye Institute
state: Western Australia
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: Glostrup
country: Denmark
facility: Glostrup Hospital, Øjenafdelingen, Forskningsafsnit Ø37
city: Bordeaux
country: France
facility: Hopital Pellegrin; Ophtalmologie
city: Dijon
country: France
facility: CHU Bocage; Ophtalmologie
city: Lyon cedex
country: France
facility: Hopital de la croix rousse; Ophtalmologie
city: Marseille
country: France
facility: Centre Paradis Monticelli; Ophtalmologie
city: Nantes
country: France
facility: Hopital Hotel Dieu Et Hme; Clinique Ophtalmologique
city: Paris
country: France
facility: CHNO des Quinze Vingts; Ophtalmologie
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde
city: Heidelberg
country: Germany
facility: Universitätsklinik Heidelberg; Augenklinik
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik
city: München
country: Germany
facility: LMU Klinikum der Universität, Augenklinik
city: München
country: Germany
facility: Klinikum rechts der Isar der TU München; Augenklinik
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde
city: Tuebingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Budapest
country: Hungary
facility: Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR
city: Budapest
country: Hungary
facility: Semmelweis Egyetem AOK, Szemeszeti Klinika
city: Pécs
country: Hungary
facility: Ganglion Medial Center
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: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica
state: Toscana
city: Udine
country: Italy
facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica
state: Veneto
city: Mexico City
country: Mexico
facility: Hospital Nuestra Señora de La Luz
city: Monterrey
country: Mexico
facility: Hospital Universitario de Monterrey
city: Querétaro
country: Mexico
facility: Instituto Mexicano de Oftalmologia I.A.P.
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre; Ophthalmology
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Lima
country: Peru
facility: Mácula D&T
city: Lima
country: Peru
facility: TG Laser Oftalmica
city: Lima
country: Peru
facility: Centro de Investigacion Oftalmolaser
city: Bydgoszcz
country: Poland
facility: OFTALMIKA Sp. z o.o
city: Bytom
country: Poland
facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki
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: Porto
country: Portugal
facility: Hospital de Sao Joao; Servico de Oftalmologia
city: Kazan
country: Russian Federation
facility: SAHI "Republic clinical ophthalmological hospial of Ministry of Heal of Tatarstan Republic"
city: Moscow
country: Russian Federation
facility: FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences
city: Samara
country: Russian Federation
facility: St. Educ.Inst. of High Prof.Education "Samara State Medical University"; Chair of ophathalmology
city: Banska Bystrica
country: Slovakia
facility: FNsP F. D. Roosevelta Banska Bystrica, II.Ocna klinika SZU
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda Ocna klinika SZU a UNB
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: Instituto de microcirugia ocular
city: Madrid
country: Spain
facility: VISSUM Madrid Santa Hortensia
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos; Servicio de Oftalmologia
city: Valencia
country: Spain
facility: Hospital Universitario la Fe: Servicio de Oftalmologia
city: Stockholm
country: Sweden
facility: St Eriks Eye Hospital
city: Bern
country: Switzerland
facility: Inselspital Bern, Universitätsklinik für Augenheilkunde
city: Binningen
country: Switzerland
facility: Vista Klinik Binningen
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty; Department of Ophthalmology
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty; Department of Ophthalmology
city: Ankara
country: Turkey
facility: Ankara Baskent University Medical Faculty; Department of Ophthalmology
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Medical Faculty; Department of Ophthalmology
city: Izmir
country: Turkey
facility: Ege University Medical Faculty; Department of Ophthalmology
city: Izmir
country: Turkey
facility: Dokuz Eylul University Medical Faculty; Department of Ophthalmology
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: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Kings College Hospital
city: Manchester
country: United Kingdom
facility: Macular Treatment Centre; Royal Eye Hospital
city: Middx
country: United Kingdom
facility: Hillingdon 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:
citation: Heier JS, Pieramici D, Chakravarthy U, Patel SS, Gupta S, Lotery A, Lad EM, Silverman D, Henry EC, Anderesi M, Tschosik EA, Gray S, Ferrara D, Guymer R; Chroma and Spectri Study Investigators. Visual Function Decline Resulting from Geographic Atrophy: Results from the Chroma and Spectri Phase 3 Trials. Ophthalmol Retina. 2020 Jul;4(7):673-688. doi: 10.1016/j.oret.2020.01.019. Epub 2020 Jan 31.
citation: Holz FG, Sadda SR, Busbee B, Chew EY, Mitchell P, Tufail A, Brittain C, Ferrara D, Gray S, Honigberg L, Martin J, Tong B, Ehrlich JS, Bressler NM; Chroma and Spectri Study Investigators. Efficacy and Safety of Lampalizumab for Geographic Atrophy Due to Age-Related Macular Degeneration: Chroma and Spectri Phase 3 Randomized Clinical Trials. JAMA Ophthalmol. 2018 Jun 1;136(6):666-677. doi: 10.1001/jamaophthalmol.2018.1544.