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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02247479
First received: July 15, 2014
Last updated: September 11, 2017
Last verified: September 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: Quadruple (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 Autofluoresence (FAF) at Year 1 [ Time Frame: Baseline, Year 1 ]

Secondary Outcome Measures:
  • Change in Number of Scotomatous Points as Assessed by Mesopic Micrometry [ Time Frame: Baseline to Week 96 ]
  • Change in Macular Sensitivity as Assessed by Mesopic Microperimetry [ Time Frame: Baseline to Week 96 ]
  • Change in GA Area as Assessed by FAF [ 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 as Assessed by ETDRS Chart Under Low Luminance Conditions [ Time Frame: Baseline to Week 96 ]
  • Change in Binocular Reading Speed as 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 as 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 ]
  • Percentage of Participants with Ocular Adverse Events [ Time Frame: Baseline up to the end of study (approximately 2 years) ]
  • Percentage of Participants with Systemic (Non-ocular) Adverse Events [ Time Frame: Baseline up to the end of study (approximately 2 years) ]
  • Percentage of Participants with Anti-Lampalizumab Antibodies [ Time Frame: Baseline up to the end of study (approximately 2 years) ]
  • Prognostic Value of the Complement Factor I (CFI) Profile Biomarker Based on the Biomarker Status at Baseline and Change in the GA Area from Baseline as Measured by FAF at Year 1 [ Time Frame: Baseline, Year 1 ]
  • Serum Lampalizumab Concentration [ Time Frame: Baseline to Week 96 ]

Enrollment: 905
Actual Study Start Date: September 17, 2014
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lampalizumab Once in Every Weeks (Q4W)
Participants will receive 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections for approximately 96 weeks.
Drug: Lampalizumab
Participants will receive 10 mg dose of lampalizumab administered intravitreally.
Other Name: RO5490249
Experimental: Lampalizumab Once in Every 6 Weeks (Q6W)
Participants will receive 10 mg dose of lampalizumab administered by intravitreal injections for approximately 96 weeks.
Drug: Lampalizumab
Participants will receive 10 mg dose of lampalizumab administered intravitreally.
Other Name: RO5490249
Sham Comparator: Sham Comparator
Participants will receive sham comparator Q4W or Q6W for 96 weeks.
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:

  • 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 (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: NCT02247479

  Hide Study Locations
Locations
United States, Alabama
Uni of Alabama At Birmingham Clinical Research Unit
Birmingham, Alabama, United States, 35233
United States, Arizona
Retinal Research Institute, LLC
Phoenix, Arizona, United States, 85014
Retina Centers P.C.
Tucson, Arizona, United States, 85704
United States, California
California Retina Consultants
Bakersfield, California, United States, 93309
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
The Gavin Herbert Eye Institute - UC, Irvine
Irvine, California, United States, 92697-4375
Jules Stein Eye Institute/ UCLA
Los Angeles, California, United States, 90095-7000
East Bay Retina Consultants
Oakland, California, United States, 94609
Southern CA Desert Retina Cons
Palm Desert, California, United States, 92211
W Coast Retina Med Group Inc
San Francisco, California, United States, 94107
UCSF; Ophthalmology
San Francisco, California, United States, 94143
Orange County Retina Med Group
Santa Ana, California, United States, 92705
California Retina Consultants
Santa Barbara, California, United States, 93103
United States, Florida
Florida Eye Microsurgical Inst
Boynton Beach, Florida, United States, 33426
National Ophthalmic Research Institute
Fort Myers, Florida, United States, 33912
Florida Eye Associates
Melbourne, Florida, United States, 32901
Retina Care Specialists
Palm Beach Gardens, Florida, United States, 33410
Bascom Palmer Eye Institute
Palm Beach Gardens, Florida, United States, 33418
Retina Specialty Institute
Pensacola, Florida, United States, 32503
Fort Lauderdale Eye Institute
Plantation, Florida, United States, 33324
Retina Vitreous Assoc of FL
Saint Petersburg, Florida, United States, 33711
Southern Vitreoretinal Assoc
Tallahassee, Florida, United States, 32308
Retina Associates of Florida, LLC
Tampa, Florida, United States, 33609
United States, Georgia
Southeast Retina Center
Augusta, Georgia, United States, 30909
Georgia Retina PC
Tucker, Georgia, United States, 30084
United States, Hawaii
Retina Consultants of Hawaii
'Aiea, Hawaii, United States, 96701
United States, Illinois
Northwestern Medical Group/Northwestern University
Chicago, Illinois, United States, 60611
University Retina and Macula Associates, PC
Oak Forest, Illinois, United States, 60452
United States, Indiana
Midwest Eye Institute Northside
Indianapolis, Indiana, United States, 46290
United States, Iowa
Wolfe Eye Clinic
West Des Moines, Iowa, United States, 50266
United States, Kansas
Retina Associates
Shawnee, Kansas, United States, 66204
United States, Kentucky
Lahey Clinic Med Ctr
Lexington, Kentucky, United States, 02421
Retina Associates of Kentucky
Lexington, Kentucky, United States, 40509
United States, Maine
Maine Eye Center
Portland, Maine, United States, 04101
United States, Maryland
Retina Specialists
Towson, Maryland, United States, 21204
United States, Massachusetts
Tufts Medical Center Research
Boston, Massachusetts, United States, 02111
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
Vitreo-Retinal Associates, PC
Worcester, Massachusetts, United States, 01605
United States, Michigan
Vitreo-Retinal Associates
Grand Rapids, Michigan, United States, 49546
Specialty Eye Institute
Jackson, Michigan, United States, 49202
Assoc Retinal Consultants PC
Royal Oak, Michigan, United States, 48073
Retina Consultants of Michigan
Southfield, Michigan, United States, 48034
United States, Nebraska
Eye Surgical Associates
Lincoln, Nebraska, United States, 68506
United States, Nevada
Retina Consultants of Nevada
Henderson, Nevada, United States, 89052
United States, New Jersey
Retina Center of New Jersey
Bloomfield, New Jersey, United States, 7003
Delaware Valley Retina Assoc
Lawrenceville, New Jersey, United States, 08648
New Jersey Retina Research Foundation
Toms River, New Jersey, United States, 08755
United States, New York
Long Is. Vitreoretinal Consult
Great Neck, New York, United States, 11021
Opthalmic Consultants of LI
Lynbrook, New York, United States, 11563
New York Eye & Ear Infirmary
New York, New York, United States, 10003
Retina Consultants of Western New York
Orchard Park, New York, United States, 14127
Retina Vit Surgeons/Central NY
Syracuse, New York, United States, 13224
United States, North Carolina
West Carolina Retinal AssocPA
Asheville, North Carolina, United States, 28803
Wake Forest Baptist Health Eye Centre
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Retina Assoc of Cleveland Inc
Beachwood, Ohio, United States, 44122
Cleveland Clinic Foundation; Cole Eye Institute
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Retina Vitreous Consultants
Monroeville, Pennsylvania, United States, 15146
Associates in Ophthalmology
West Mifflin, Pennsylvania, United States, 15122
United States, South Carolina
Charleston Neuroscience Inst
Ladson, South Carolina, United States, 29456
United States, Tennessee
Tennessee Retina PC.
Nashville, Tennessee, United States, 37203
Vanderbilt
Nashville, Tennessee, United States, 37232
United States, Texas
Retina Res Institute of Texas
Abilene, Texas, United States, 79606
Texas Retina Associates
Arlington, Texas, United States, 76012
Austin Retina Associates
Austin, Texas, United States, 78705
Retina Research Center
Austin, Texas, United States, 78705
UT Southwestern MC at Dallas
Dallas, Texas, United States, 75390
Valley Retina Institute P.A.
McAllen, Texas, United States, 78503
Strategic Clinical Research Group, LLC
Willow Park, Texas, United States, 76087
United States, Utah
Retina Associates of Utah
Salt Lake City, Utah, United States, 84107
United States, Virginia
Eye Surgeons of Richmond Inc. dba Virginia Eye Institute
Richmond, Virginia, United States, 23226
Retina Institute of Virginia
Richmond, Virginia, United States, 23235
Virginia Retina Center
Warrenton, Virginia, United States, 20186
United States, Washington
Retina Center Northwest
Silverdale, Washington, United States, 98383
Spokane Eye Clinical Research
Spokane, Washington, United States, 99204
United States, West Virginia
West Virginia University Eye Institute
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Argentina
Organizacion Medica de Investigacion
Buenos Aires, Argentina, C1015ABO
Fundacion Zambrano
Caba, Argentina, 1023
Oftar
Mendoza, Argentina, M5500GGK
Microcirugía Ocular S.A
Rosario, Argentina, S2000CTC
Grupo Laser Vision
Rosario, Argentina, S2000DLA
Australia, New South Wales
Eyeclinic Albury Wodonga
Albury, New South Wales, Australia, 2640
Marsden Eye Research Centre
Parramatta, New South Wales, Australia, 2150
Save Sight Institute
Sydney, New South Wales, Australia, 2000
Sydney West Retina
Westmead, New South Wales, Australia, 2145
Austria
Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde
Linz, Austria, 4021
Belgium
CHU Brugmann (Victor Horta)
Bruxelles, Belgium, 1020
UZ Gent
Gent, Belgium, 9000
UZ Leuven Sint Rafael
Leuven, Belgium, 3000
CHU Sart-Tilman
Liège, Belgium, 4000
Canada, Alberta
Calgary Retina Consultants
Calgary, Alberta, Canada, T2J 0C8
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V5Z 3N9
Canada, Nova Scotia
QEII - HSC Department of Ophthalmology
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
University of Ottawa Eye Institute
Ottawa, Ontario, Canada, K1H 8L6
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
St. Michael'S Hospital
Toronto, Ontario, Canada, M5G 2C4
University Health Network Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
Institut De L'Oeil Des Laurentides
Boisbriand, Quebec, Canada, J7H 1S6
Denmark
Sjællands Universitetshospital, Roskilde; Øjenafdelingen
Roskilde, Denmark, 4000
France
Chi De Creteil; Ophtalmologie
Creteil, France, 94010
Centre Odeon; Exploration Ophtalmologique
Paris, France, 75006
Hopital Lariboisiere; Ophtalmologie
Paris, France, 75010
Centre Ophtalmologique; Imagerie et laser
Paris, France, 75015
Ch Pitie Salpetriere; Ophtalmologie
Paris, France, 75651
CHU Poitiers - CHR La Miletrie; Ophtalmologie
Poitiers, France, 86021
Germany
Universitäts-Augenklinik Bonn
Bonn, Germany, 53127
Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde
Göttingen, Germany, 37075
Medizinische Hochschule Hannover, Klinik für Augenheilkunde
Hannover, Germany, 30625
Universitätsklinikum Köln; Augenklinik
Köln, Germany, 50937
Universitätskliniikum Schleswig-Holstein, Campus Lübeck, Klinik für Augenheilkunde
Lübeck, Germany, 23538
Augenabteilung am St. Franziskus-Hospital
Münster, Germany, 48145
Universitätsklinikum Münster; Augenheilkunde
Münster, Germany, 48149
Hungary
Budapest Retina Associates Kft.
Budapest, Hungary, 1133
Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
Debrecem, Hungary, 4032
Ganglion Medial Center
Pecs, Hungary, 7621
Italy
Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche
Roma, Lazio, Italy, 00133
Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
Roma, Lazio, Italy, 00198
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica
Milano, Lombardia, Italy, 20100
Azienda Ospedaliero Universitaria Di Sassari;U.O. Oculistica
Sassari, Sardegna, Italy, 07100
Mexico
Macula Retina Consultores
Mexico, D.F., Mexico, 01120
Hospital de la Ceguera APEC
Mexico, D.F., Mexico, 04030
Netherlands
Academisch Medisch Centrum Universiteit Amsterdam
Amsterdam, Netherlands, 1105 AZ
Leids Universitair Medisch Centrum
Leiden, Netherlands, 2300 RC
Radboud University Nijmegen Medical Centre; Ophthalmology
Nijmegen, Netherlands, 6525 EX
Peru
CLINICA RICARDO PALMA; Oftalmologos Contreras
Lima, Peru, 27
Clinica Anglo Americana
Lima, Peru, Lima 27
Poland
OFTALMIKA Sp. z o.o
Bydgoszcz, Poland, 85-631
Optimum Profesorskie Centrum Okulistyki
Gdańsk, Poland, 80-809
Gabinet Okulistyczny Prof Edward Wylegala
Katowice, Poland, 40-594
SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej
Krakow, Poland, 31-501
Slovakia
Nemocnica sv. Michala, a.s.
Bratislava, Slovakia, 81108
Fakultna nemocnica Trencin Ocna klinika
Trencin, Slovakia, 911 71
Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie
Zilina, Slovakia, 012 07
Spain
Hospital Universitari de Bellvitge; Servicio de Oftalmologia
Hospitalet De Llobregat, Barcelona, Spain, 8907
Hospital General de Catalunya
San Cugat del Valles, Barcelona, Spain, 08195
Instituto Clinico Quirurgico de Oftalmologia - ICQO
Bilbao, Guipuzcoa, Spain, 48006
VISSUM Instituto Oftalmológico de Alicante
Alicante, Spain, 03016
Institut de la Macula i la retina
Barcelona, Spain, 08022
FISABIO. Fundación Oftalmologica del Mediterraneo
Valencia, Spain, 46015
Hospital Universitario Rio Hortega; Servicio de Oftalmologia
Valladolid, Spain, 47012
Switzerland
Stadtspital Triemli; Augenklinik
Zürich, Switzerland, 8063
United Kingdom
Ayr Hospital
AYR, United Kingdom, KA6 6DX
The Princess Alexandra Eye Pavilion
Edinburgh, United Kingdom, EH3 9HA
Frimley Park Hospital
Frimley, United Kingdom, GU16 7UJ
Royal Hallamshire Hospita
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02247479     History of Changes
Other Study ID Numbers: GX29176
2014-000107-27 ( EudraCT Number )
Study First Received: July 15, 2014
Last Updated: September 11, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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 September 21, 2017