Clinical trial NCT02247479: A Study Investigating the Efficacy and Safety 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: 906
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:

* 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 (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 Atrophy (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 as Assessed by Mesopic Micrometry at Week 48
timeFrame: Baseline, Week 48
measure: Change From Baseline in Mean 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: 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: Tucson
country: United States
facility: Retina Centers P.C.
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: Irvine
country: United States
facility: The Gavin Herbert Eye Institute - UC, Irvine
state: California
city: Los Angeles
country: United States
facility: Jules Stein Eye Institute/ UCLA
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: San Francisco
country: United States
facility: W Coast Retina Med Group Inc
state: California
city: San Francisco
country: United States
facility: UCSF; 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: Boynton Beach
country: United States
facility: Florida Eye Microsurgical Inst
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: 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: 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: Chicago
country: United States
facility: Northwestern Medical Group/Northwestern University
state: Illinois
city: Oak Forest
country: United States
facility: University Retina and Macula Associates, PC
state: Illinois
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: Lexington
country: United States
facility: Lahey Clinic Med Ctr
state: Kentucky
city: Lexington
country: United States
facility: Retina Associates of Kentucky
state: Kentucky
city: Portland
country: United States
facility: Maine Eye Center
state: Maine
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: Ophthalmic Consultants of Boston
state: Massachusetts
city: Worcester
country: United States
facility: Vitreo-Retinal Associates, PC
state: Massachusetts
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: Lincoln
country: United States
facility: Eye Surgical Associates
state: Nebraska
city: Las Vegas
country: United States
facility: Retina Consultants of Nevada
state: Nevada
city: Bloomfield
country: United States
facility: Retina Center of New Jersey
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: 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: Orchard Park
country: United States
facility: Retina Consultants of Western New York
state: New York
city: Syracuse
country: United States
facility: Retina Vit Surgeons/Central NY
state: New York
city: Asheville
country: United States
facility: Western Carolina Retinal Associate PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health Eye Centre
state: North Carolina
city: Beachwood
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: Monroeville
country: United States
facility: Retina Vitreous Consultants
state: Pennsylvania
city: West Mifflin
country: United States
facility: Associates in Ophthalmology
state: Pennsylvania
city: Ladson
country: United States
facility: Charleston Neuroscience Inst
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Retina PC.
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt
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: UT Southwestern MC at Dallas
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute P.A.
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: 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: 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: Buenos Aires
country: Argentina
facility: Organizacion Medica de Investigacion
city: Caba
country: Argentina
facility: Fundacion Zambrano
city: Mendoza
country: Argentina
facility: Oftar
city: Rosario
country: Argentina
facility: Microcirugía Ocular S.A
city: Rosario
country: Argentina
facility: Grupo Laser Vision
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: Linz
country: Austria
facility: Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde
city: Bruxelles
country: Belgium
facility: CHU Brugmann (Victor Horta)
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven Sint Rafael
city: Liège
country: Belgium
facility: CHU Sart-Tilman
city: Calgary
country: Canada
facility: Calgary Retina Consultants
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Halifax
country: Canada
facility: QEII - HSC Department of Ophthalmology
state: Nova Scotia
city: Ottawa
country: Canada
facility: University of Ottawa Eye Institute
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael'S Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network Toronto Western Hospital
state: Ontario
city: Boisbriand
country: Canada
facility: Institut De L'Oeil Des Laurentides
state: Quebec
city: Roskilde
country: Denmark
facility: Sjællands Universitetshospital, Roskilde; Øjenafdelingen
city: Creteil
country: France
facility: Chi De Creteil; Ophtalmologie
city: Paris
country: France
facility: Centre Odeon; Exploration Ophtalmologique
city: Paris
country: France
facility: Hopital Lariboisiere; Ophtalmologie
city: Paris
country: France
facility: Centre Ophtalmologique; Imagerie et laser
city: Paris
country: France
facility: Ch Pitie Salpetriere; Ophtalmologie
city: Poitiers
country: France
facility: CHU Poitiers - CHR La Miletrie; Ophtalmologie
city: Bonn
country: Germany
facility: Universitäts-Augenklinik Bonn
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Klinik für Augenheilkunde
city: Köln
country: Germany
facility: Universitätsklinikum Köln; Augenklinik
city: Lübeck
country: Germany
facility: Universitätskliniikum Schleswig-Holstein, Campus Lübeck, Klinik für Augenheilkunde
city: Münster
country: Germany
facility: Augenabteilung am St. Franziskus-Hospital
city: Münster
country: Germany
facility: Universitätsklinikum Münster; Augenheilkunde
city: Budapest
country: Hungary
facility: Budapest Retina Associates Kft.
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: Roma
country: Italy
facility: Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
state: Lazio
city: Milano
country: Italy
facility: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica
state: Lombardia
city: Sassari
country: Italy
facility: Azienda Ospedaliero Universitaria Di Sassari;U.O. Oculistica
state: Sardegna
city: Mexico, D.F.
country: Mexico
facility: Macula Retina Consultores
city: Mexico, D.F.
country: Mexico
facility: Hospital de la Ceguera APEC
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum Universiteit Amsterdam
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre; Ophthalmology
city: Lima
country: Peru
facility: CLINICA RICARDO PALMA; Oftalmologos Contreras
city: Lima
country: Peru
facility: Clinica Anglo Americana
city: Bydgoszcz
country: Poland
facility: OFTALMIKA Sp. z o.o
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: Bratislava
country: Slovakia
facility: Nemocnica sv. Michala, a.s.
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: San Cugat Del Valles
country: Spain
facility: Hospital General de Catalunya
state: Barcelona
city: Bilbao
country: Spain
facility: Instituto Clinico Quirurgico de Oftalmologia - ICQO
state: Guipuzcoa
city: Alicante
country: Spain
facility: VISSUM Instituto Oftalmológico de Alicante
city: Barcelona
country: Spain
facility: Institut de la Macula i la retina
city: Valencia
country: Spain
facility: FISABIO. Fundación Oftalmologica del Mediterraneo
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia
city: Zürich
country: Switzerland
facility: Stadtspital Triemli; Augenklinik
city: AYR
country: United Kingdom
facility: Ayr Hospital
city: Edinburgh
country: United Kingdom
facility: The Princess Alexandra Eye Pavilion
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospita
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Miere A, Capuano V, Kessler A, Zambrowski O, Jung C, Colantuono D, Pallone C, Semoun O, Petit E, Souied E. Deep learning-based classification of retinal atrophy using fundus autofluorescence imaging. Comput Biol Med. 2021 Mar;130:104198. doi: 10.1016/j.compbiomed.2020.104198. Epub 2020 Dec 28.
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.