A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
CHROMA
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
2 other identifiers
interventional
906
18 countries
144
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2014
Typical duration for phase_3
144 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2014
CompletedStudy Start
First participant enrolled
September 18, 2014
CompletedFirst Posted
Study publicly available on registry
September 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 29, 2018
CompletedResults Posted
Study results publicly available
April 23, 2019
CompletedJune 26, 2019
June 1, 2019
3.4 years
July 15, 2014
January 22, 2019
June 17, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48
The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
Baseline, Week 48
Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48
For CFI profile, positive or negative biomarker status refers to the presence (carrier) or absence of the risk allele at CFI and at least one risk allele at complement factor H (CFH) or risk locus containing both complement component 2 and complement factor B (C2/CFB).The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
Baseline, Week 48
Secondary Outcomes (12)
Change From Baseline in Number of Absolute Scotomatous Points as Assessed by Mesopic Micrometry at Week 48
Baseline, Week 48
Change From Baseline in Mean Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48
Baseline, Week 48
Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Week 48
Baseline, Week 48
Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week 48
Week 48
Change From Baseline in Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions at Week 48
Baseline, Week 48
- +7 more secondary outcomes
Study Arms (3)
Lampalizumab Once in Every 4 Weeks (Q4W)
EXPERIMENTALParticipants will receive 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections for approximately 96 weeks.
Lampalizumab Once in Every 6 Weeks (Q6W)
EXPERIMENTALParticipants will receive 10 mg dose of lampalizumab administered by intravitreal injections for approximately 96 weeks.
Sham Comparator
SHAM COMPARATORParticipants will receive sham comparator Q4W or Q6W for 96 weeks.
Interventions
Participants will receive 10 mg dose of lampalizumab administered intravitreally.
A sham injection is a procedure that mimics an intravitreal injection of lampalizumab.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- GA in either eye due to causes other than AMD
- Previous treatment with eculizumab, lampalizumab and/or fenretinide
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (145)
Uni of Alabama At Birmingham Clinical Research Unit
Birmingham, Alabama, 35233, United States
Retinal Research Institute, LLC
Phoenix, Arizona, 85014, United States
Retina Centers P.C.
Tucson, Arizona, 85704, United States
California Retina Consultants
Bakersfield, California, 93309, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211, United States
The Gavin Herbert Eye Institute - UC, Irvine
Irvine, California, 92697-4375, United States
Jules Stein Eye Institute/ UCLA
Los Angeles, California, 90095-7000, United States
East Bay Retina Consultants
Oakland, California, 94609, United States
Southern CA Desert Retina Cons
Palm Desert, California, 92211, United States
W Coast Retina Med Group Inc
San Francisco, California, 94107, United States
UCSF; Ophthalmology
San Francisco, California, 94143, United States
Orange County Retina Med Group
Santa Ana, California, 92705, United States
California Retina Consultants
Santa Barbara, California, 93103, United States
Florida Eye Microsurgical Inst
Boynton Beach, Florida, 33426, United States
National Ophthalmic Research Institute
Fort Myers, Florida, 33912, United States
Florida Eye Associates
Melbourne, Florida, 32901, United States
Retina Care Specialists
Palm Beach Gardens, Florida, 33410, United States
Bascom Palmer Eye Institute
Palm Beach Gardens, Florida, 33418, United States
Retina Specialty Institute
Pensacola, Florida, 32503, United States
Fort Lauderdale Eye Institute
Plantation, Florida, 33324, United States
Retina Vitreous Assoc of FL
St. Petersburg, Florida, 33711, United States
Southern Vitreoretinal Assoc
Tallahassee, Florida, 32308, United States
Retina Associates of Florida, LLC
Tampa, Florida, 33609, United States
Southeast Retina Center
Augusta, Georgia, 30909, United States
Georgia Retina PC
Marietta, Georgia, 30060, United States
Retina Consultants of Hawaii
‘Aiea, Hawaii, 96701, United States
Northwestern Medical Group/Northwestern University
Chicago, Illinois, 60611, United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, 60452, United States
Midwest Eye Institute Northside
Indianapolis, Indiana, 46290, United States
Wolfe Eye Clinic
West Des Moines, Iowa, 50266, United States
Retina Associates
Shawnee Mission, Kansas, 66204, United States
Lahey Clinic Med Ctr
Lexington, Kentucky, 02421, United States
Retina Associates of Kentucky
Lexington, Kentucky, 40509, United States
Maine Eye Center
Portland, Maine, 04101, United States
Retina Specialists
Towson, Maryland, 21204, United States
Tufts Medical Center Research
Boston, Massachusetts, 02111, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
Vitreo-Retinal Associates, PC
Worcester, Massachusetts, 01605, United States
Vitreo-Retinal Associates
Grand Rapids, Michigan, 49546, United States
Specialty Eye Institute
Jackson, Michigan, 49202, United States
Assoc Retinal Consultants PC
Royal Oak, Michigan, 48073, United States
Retina Consultants of Michigan
Southfield, Michigan, 48034, United States
Eye Surgical Associates
Lincoln, Nebraska, 68506, United States
Retina Consultants of Nevada
Las Vegas, Nevada, 89123, United States
Retina Center of New Jersey
Bloomfield, New Jersey, 07003, United States
New Jersey Retina Research Foundation
Edison, New Jersey, 08820, United States
Delaware Valley Retina Assoc
Lawrenceville, New Jersey, 08648, United States
Long Is. Vitreoretinal Consult
Hauppauge, New York, 11788, United States
Opthalmic Consultants of LI
Lynbrook, New York, 11563, United States
New York Eye & Ear Infirmary
New York, New York, 10003, United States
Retina Consultants of Western New York
Orchard Park, New York, 14127, United States
Retina Vit Surgeons/Central NY
Syracuse, New York, 13224, United States
Western Carolina Retinal Associate PA
Asheville, North Carolina, 28803, United States
Wake Forest Baptist Health Eye Centre
Winston-Salem, North Carolina, 27157, United States
Retina Assoc of Cleveland Inc
Beachwood, Ohio, 44122, United States
Cleveland Clinic Foundation; Cole Eye Institute
Cleveland, Ohio, 44195, United States
Retina Vitreous Consultants
Monroeville, Pennsylvania, 15146, United States
Associates in Ophthalmology
West Mifflin, Pennsylvania, 15122, United States
Charleston Neuroscience Inst
Ladson, South Carolina, 29456, United States
Tennessee Retina PC.
Nashville, Tennessee, 37203, United States
Vanderbilt
Nashville, Tennessee, 37232, United States
Retina Res Institute of Texas
Abilene, Texas, 79606, United States
Texas Retina Associates
Arlington, Texas, 76012, United States
Austin Retina Associates
Austin, Texas, 78705, United States
Retina Research Center
Austin, Texas, 78705, United States
UT Southwestern MC at Dallas
Dallas, Texas, 75390, United States
Valley Retina Institute P.A.
McAllen, Texas, 78503, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, 76087, United States
Retina Associates of Utah
Salt Lake City, Utah, 84107, United States
Eye Surgeons of Richmond Inc. dba Virginia Eye Institute
Richmond, Virginia, 23226, United States
Retina Institute of Virginia
Richmond, Virginia, 23235, United States
Virginia Retina Center
Warrenton, Virginia, 20186, United States
Retina Center Northwest
Silverdale, Washington, 98383, United States
Spokane Eye Clinical Research
Spokane, Washington, 99204, United States
West Virginia University Eye Institute
Morgantown, West Virginia, 26506, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Organizacion Medica de Investigacion
Buenos Aires, C1015ABO, Argentina
Fundacion Zambrano
CABA, 1023, Argentina
Oftar
Mendoza, M5500GGK, Argentina
Microcirugía Ocular S.A
Rosario, S2000CTC, Argentina
Grupo Laser Vision
Rosario, S2000DLA, Argentina
Eyeclinic Albury Wodonga
Albury, New South Wales, 2640, Australia
Marsden Eye Research Centre
Parramatta, New South Wales, 2150, Australia
Save Sight Institute
Sydney, New South Wales, 2000, Australia
Sydney West Retina
Westmead, New South Wales, 2145, Australia
Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde
Linz, 4021, Austria
CHU Brugmann (Victor Horta)
Brussels, 1020, Belgium
UZ Gent
Ghent, 9000, Belgium
UZ Leuven Sint Rafael
Leuven, 3000, Belgium
CHU Sart-Tilman
Liège, 4000, Belgium
Calgary Retina Consultants
Calgary, Alberta, T2J 0C8, Canada
University of British Columbia
Vancouver, British Columbia, V6T 1Z4, Canada
QEII - HSC Department of Ophthalmology
Halifax, Nova Scotia, B3H 2Y9, Canada
University of Ottawa Eye Institute
Ottawa, Ontario, K1H 8L6, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
St. Michael'S Hospital
Toronto, Ontario, M5G 2C4, Canada
University Health Network Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
Institut De L'Oeil Des Laurentides
Boisbriand, Quebec, J7H 1S6, Canada
Sjællands Universitetshospital, Roskilde; Øjenafdelingen
Roskilde, 4000, Denmark
Chi De Creteil; Ophtalmologie
Créteil, 94010, France
Centre Odeon; Exploration Ophtalmologique
Paris, 75006, France
Hopital Lariboisiere; Ophtalmologie
Paris, 75010, France
Centre Ophtalmologique; Imagerie et laser
Paris, 75015, France
Ch Pitie Salpetriere; Ophtalmologie
Paris, 75651, France
CHU Poitiers - CHR La Miletrie; Ophtalmologie
Poitiers, 86021, France
Universitäts-Augenklinik Bonn
Bonn, 53127, Germany
Universitätsklinikum Köln; Augenklinik
Cologne, 50937, Germany
Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde
Göttingen, 37075, Germany
Medizinische Hochschule Hannover, Klinik für Augenheilkunde
Hanover, 30625, Germany
Universitätskliniikum Schleswig-Holstein, Campus Lübeck, Klinik für Augenheilkunde
Lübeck, 23538, Germany
Augenabteilung am St. Franziskus-Hospital
Münster, 48145, Germany
Universitätsklinikum Münster; Augenheilkunde
Münster, 48149, Germany
Budapest Retina Associates Kft.
Budapest, 1133, Hungary
Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
Debrecem, 4032, Hungary
Ganglion Medial Center
Pécs, 7621, Hungary
Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche
Rome, Lazio, 00133, Italy
Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
Rome, Lazio, 00198, Italy
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica
Milan, Lombardy, 20100, Italy
Azienda Ospedaliero Universitaria Di Sassari;U.O. Oculistica
Sassari, Sardinia, 07100, Italy
Macula Retina Consultores
Mexico City, 01120, Mexico
Hospital de la Ceguera APEC
Mexico City, 04030, Mexico
Academisch Medisch Centrum Universiteit Amsterdam
Amsterdam, 1105 AZ, Netherlands
Leids Universitair Medisch Centrum
Leiden, 2333 ZA0, Netherlands
Radboud University Nijmegen Medical Centre; Ophthalmology
Nijmegen, 6525 EX, Netherlands
CLINICA RICARDO PALMA; Oftalmologos Contreras
Lima, 27, Peru
Clinica Anglo Americana
Lima, Lima 27, Peru
OFTALMIKA Sp. z o.o
Bydgoszcz, 85-631, Poland
Optimum Profesorskie Centrum Okulistyki
Gdansk, 80-809, Poland
Gabinet Okulistyczny Prof Edward Wylegala
Katowice, 40-594, Poland
SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej
Krakow, 31-501, Poland
Nemocnica sv. Michala, a.s.
Bratislava, 81108, Slovakia
Fakultna nemocnica Trencin Ocna klinika
Trenčín, 911 71, Slovakia
Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie
Žilina, 012 07, Slovakia
Hospital Universitari de Bellvitge; Servicio de Oftalmologia
L'Hospitalet de Llobregat, Barcelona, 8907, Spain
Hospital General de Catalunya
San Cugat Del Valles, Barcelona, 08195, Spain
Instituto Clinico Quirurgico de Oftalmologia - ICQO
Bilbao, Guipuzcoa, 48006, Spain
VISSUM Instituto Oftalmológico de Alicante
Alicante, 03016, Spain
Institut de la Macula i la retina
Barcelona, 08022, Spain
FISABIO. Fundación Oftalmologica del Mediterraneo
Valencia, 46015, Spain
Hospital Universitario Rio Hortega; Servicio de Oftalmologia
Valladolid, 47012, Spain
Stadtspital Triemli; Augenklinik
Zurich, 8063, Switzerland
Ayr Hospital
Ayr, KA6 6DX, United Kingdom
The Princess Alexandra Eye Pavilion
Edinburgh, EH3 9HA, United Kingdom
Frimley Park Hospital
Frimley, GU16 7UJ, United Kingdom
Royal Hallamshire Hospita
Sheffield, S10 2JF, United Kingdom
Related Publications (8)
Salvi A, Cluceru J, Gao SS, Rabe C, Schiffman C, Yang Q, Lee AY, Keane PA, Sadda SR, Holz FG, Ferrara D, Anegondi N. Deep Learning to Predict the Future Growth of Geographic Atrophy from Fundus Autofluorescence. Ophthalmol Sci. 2024 Oct 23;5(2):100635. doi: 10.1016/j.xops.2024.100635. eCollection 2025 Mar-Apr.
PMID: 39758130DERIVEDCluceru J, Anegondi N, Gao SS, Lee AY, Lad EM, Chakravarthy U, Yang Q, Steffen V, Friesenhahn M, Rabe C, Ferrara D. Topographic Clinical Insights From Deep Learning-Based Geographic Atrophy Progression Prediction. Transl Vis Sci Technol. 2024 Aug 1;13(8):6. doi: 10.1167/tvst.13.8.6.
PMID: 39102242DERIVEDBressler NM, Freund KB, Bakri SJ, Kim JE, Ferrara D, Brittain C, Pickthorn K, Lin H, Sun C, Martin J. Intraocular Pressure Outcomes After Lampalizumab Injections in Patients With Geographic Atrophy. JAMA Ophthalmol. 2024 Aug 1;142(8):772-776. doi: 10.1001/jamaophthalmol.2024.2061.
PMID: 38900484DERIVEDChang DS, Callaway NF, Steffen V, Csaky K, Guymer RH, Birch DG, Patel PJ, Ip M, Gao SS, Briggs J, Honigberg L, Lai P, Ferrara D, Sepah YJ. Macular Sensitivity Endpoints in Geographic Atrophy: Exploratory Analysis of Chroma and Spectri Clinical Trials. Ophthalmol Sci. 2023 Jun 12;4(1):100351. doi: 10.1016/j.xops.2023.100351. eCollection 2024 Jan-Feb.
PMID: 37869030DERIVEDTzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3.
PMID: 37314061DERIVEDMiere 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.
PMID: 33383315DERIVEDHeier 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.
PMID: 32199866DERIVEDHolz 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.
PMID: 29801123DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated early by the Sponsor because the compound had demonstrated to lack of efficacy. Thus, not all participants in this study completed the full duration of treatment.
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2014
First Posted
September 25, 2014
Study Start
September 18, 2014
Primary Completion
January 29, 2018
Study Completion
January 29, 2018
Last Updated
June 26, 2019
Results First Posted
April 23, 2019
Record last verified: 2019-06