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Geographic AtrophyPhase 3CHROMANCT02247479

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

A Phase 3 study testing Lampalizumab in people with Geographic Atrophy, run by Hoffmann-La Roche at 145 sites in 19 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Geographic Atrophy
What is being tested?
Lampalizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
906 participants
Where
145 sitesin 19 countries
Study dates
18 Sep 2014to 29 Jan 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

145 sites in 19 countries.

145 sites in 19 countries

United States76 sites

  • Retina Consultants of Hawaii

    ‘Aiea, Hawaii, 96701

  • Retina Res Institute of Texas

    Abilene, Texas, 79606

  • Texas Retina Associates

    Arlington, Texas, 76012

  • Western Carolina Retinal Associate PA

    Asheville, North Carolina, 28803

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • Austin Retina Associates

    Austin, Texas, 78705

  • Retina Research Center

    Austin, Texas, 78705

  • California Retina Consultants

    Bakersfield, California, 93309

  • Retina Assoc of Cleveland Inc

    Beachwood, Ohio, 44122

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California, 90211

  • Uni of Alabama At Birmingham Clinical Research Unit

    Birmingham, Alabama, 35233

  • Retina Center of New Jersey

    Bloomfield, New Jersey, 07003

  • Tufts Medical Center Research

    Boston, Massachusetts, 02111

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114

  • Florida Eye Microsurgical Inst

    Boynton Beach, Florida, 33426

  • Northwestern Medical Group/Northwestern University

    Chicago, Illinois, 60611

  • Cleveland Clinic Foundation; Cole Eye Institute

    Cleveland, Ohio, 44195

  • UT Southwestern MC at Dallas

    Dallas, Texas, 75390

  • New Jersey Retina Research Foundation

    Edison, New Jersey, 08820

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912

  • Vitreo-Retinal Associates

    Grand Rapids, Michigan, 49546

  • Long Is. Vitreoretinal Consult

    Hauppauge, New York, 11788

  • Midwest Eye Institute Northside

    Indianapolis, Indiana, 46290

  • The Gavin Herbert Eye Institute - UC, Irvine

    Irvine, California, 92697-4375

  • Specialty Eye Institute

    Jackson, Michigan, 49202

  • Charleston Neuroscience Inst

    Ladson, South Carolina, 29456

  • Retina Consultants of Nevada

    Las Vegas, Nevada, 89123

  • Delaware Valley Retina Assoc

    Lawrenceville, New Jersey, 08648

  • Lahey Clinic Med Ctr

    Lexington, Kentucky, 02421

  • Retina Associates of Kentucky

    Lexington, Kentucky, 40509

  • Eye Surgical Associates

    Lincoln, Nebraska, 68506

  • Jules Stein Eye Institute/ UCLA

    Los Angeles, California, 90095-7000

  • Opthalmic Consultants of LI

    Lynbrook, New York, 11563

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Georgia Retina PC

    Marietta, Georgia, 30060

  • Valley Retina Institute P.A.

    McAllen, Texas, 78503

  • Florida Eye Associates

    Melbourne, Florida, 32901

  • Retina Vitreous Consultants

    Monroeville, Pennsylvania, 15146

  • West Virginia University Eye Institute

    Morgantown, West Virginia, 26506

  • Tennessee Retina PC.

    Nashville, Tennessee, 37203

  • Vanderbilt

    Nashville, Tennessee, 37232

  • New York Eye & Ear Infirmary

    New York, New York, 10003

  • University Retina and Macula Associates, PC

    Oak Forest, Illinois, 60452

  • East Bay Retina Consultants

    Oakland, California, 94609

  • Retina Consultants of Western New York

    Orchard Park, New York, 14127

  • Retina Care Specialists

    Palm Beach Gardens, Florida, 33410

  • Bascom Palmer Eye Institute

    Palm Beach Gardens, Florida, 33418

  • Southern CA Desert Retina Cons

    Palm Desert, California, 92211

  • Retina Specialty Institute

    Pensacola, Florida, 32503

  • Retinal Research Institute, LLC

    Phoenix, Arizona, 85014

  • Fort Lauderdale Eye Institute

    Plantation, Florida, 33324

  • Maine Eye Center

    Portland, Maine, 04101

  • Eye Surgeons of Richmond Inc. dba Virginia Eye Institute

    Richmond, Virginia, 23226

  • Retina Institute of Virginia

    Richmond, Virginia, 23235

  • Assoc Retinal Consultants PC

    Royal Oak, Michigan, 48073

  • Retina Associates of Utah

    Salt Lake City, Utah, 84107

  • W Coast Retina Med Group Inc

    San Francisco, California, 94107

  • UCSF; Ophthalmology

    San Francisco, California, 94143

  • Orange County Retina Med Group

    Santa Ana, California, 92705

  • California Retina Consultants

    Santa Barbara, California, 93103

  • Retina Associates

    Shawnee Mission, Kansas, 66204

  • Retina Center Northwest

    Silverdale, Washington, 98383

  • Retina Consultants of Michigan

    Southfield, Michigan, 48034

  • Spokane Eye Clinical Research

    Spokane, Washington, 99204

  • Retina Vitreous Assoc of FL

    St. Petersburg, Florida, 33711

  • Retina Vit Surgeons/Central NY

    Syracuse, New York, 13224

  • Southern Vitreoretinal Assoc

    Tallahassee, Florida, 32308

  • Retina Associates of Florida, LLC

    Tampa, Florida, 33609

  • Retina Specialists

    Towson, Maryland, 21204

  • Retina Centers P.C.

    Tucson, Arizona, 85704

  • Virginia Retina Center

    Warrenton, Virginia, 20186

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266

  • Associates in Ophthalmology

    West Mifflin, Pennsylvania, 15122

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087

  • Wake Forest Baptist Health Eye Centre

    Winston-Salem, North Carolina, 27157

  • Vitreo-Retinal Associates, PC

    Worcester, Massachusetts, 01605

Other trials in United States

Canada8 sites

  • Institut De L'Oeil Des Laurentides

    Boisbriand, Quebec, J7H 1S6

  • Calgary Retina Consultants

    Calgary, Alberta, T2J 0C8

  • QEII - HSC Department of Ophthalmology

    Halifax, Nova Scotia, B3H 2Y9

  • University of Ottawa Eye Institute

    Ottawa, Ontario, K1H 8L6

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • St. Michael'S Hospital

    Toronto, Ontario, M5G 2C4

  • University Health Network Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

  • University of British Columbia

    Vancouver, British Columbia, V6T 1Z4

Other trials in Canada

Germany7 sites

  • Universitäts-Augenklinik Bonn

    Bonn, 53127

  • Universitätsklinikum Köln; Augenklinik

    Cologne, 50937

  • Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde

    Göttingen, 37075

  • Medizinische Hochschule Hannover, Klinik für Augenheilkunde

    Hanover, 30625

  • Universitätskliniikum Schleswig-Holstein, Campus Lübeck, Klinik für Augenheilkunde

    Lübeck, 23538

  • Augenabteilung am St. Franziskus-Hospital

    Münster, 48145

  • Universitätsklinikum Münster; Augenheilkunde

    Münster, 48149

Other trials in Germany

Spain7 sites

  • VISSUM Instituto Oftalmológico de Alicante

    Alicante, 03016

  • Institut de la Macula i la retina

    Barcelona, 08022

  • Instituto Clinico Quirurgico de Oftalmologia - ICQO

    Bilbao, Guipuzcoa, 48006

  • Hospital Universitari de Bellvitge; Servicio de Oftalmologia

    L'Hospitalet de Llobregat, Barcelona, 8907

  • Hospital General de Catalunya

    San Cugat Del Valles, Barcelona, 08195

  • FISABIO. Fundación Oftalmologica del Mediterraneo

    Valencia, 46015

  • Hospital Universitario Rio Hortega; Servicio de Oftalmologia

    Valladolid, 47012

Other trials in Spain

France6 sites

  • Chi De Creteil; Ophtalmologie

    Créteil, 94010

  • Centre Odeon; Exploration Ophtalmologique

    Paris, 75006

  • Hopital Lariboisiere; Ophtalmologie

    Paris, 75010

  • Centre Ophtalmologique; Imagerie et laser

    Paris, 75015

  • Ch Pitie Salpetriere; Ophtalmologie

    Paris, 75651

  • CHU Poitiers - CHR La Miletrie; Ophtalmologie

    Poitiers, 86021

Other trials in France

Argentina5 sites

  • Organizacion Medica de Investigacion

    Buenos Aires, C1015ABO

  • Fundacion Zambrano

    CABA, 1023

  • Oftar

    Mendoza, M5500GGK

  • Microcirugía Ocular S.A

    Rosario, S2000CTC

  • Grupo Laser Vision

    Rosario, S2000DLA

Other trials in Argentina

Australia4 sites

  • Eyeclinic Albury Wodonga

    Albury, New South Wales, 2640

  • Marsden Eye Research Centre

    Parramatta, New South Wales, 2150

  • Save Sight Institute

    Sydney, New South Wales, 2000

  • Sydney West Retina

    Westmead, New South Wales, 2145

Other trials in Australia

Belgium4 sites

  • CHU Brugmann (Victor Horta)

    Brussels, 1020

  • UZ Gent

    Ghent, 9000

  • UZ Leuven Sint Rafael

    Leuven, 3000

  • CHU Sart-Tilman

    Liège, 4000

Other trials in Belgium

Italy4 sites

  • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica

    Milan, Lombardy, 20100

  • Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche

    Rome, Lazio, 00133

  • Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico

    Rome, Lazio, 00198

  • Azienda Ospedaliero Universitaria Di Sassari;U.O. Oculistica

    Sassari, Sardinia, 07100

Other trials in Italy

Poland4 sites

  • OFTALMIKA Sp. z o.o

    Bydgoszcz, 85-631

  • Optimum Profesorskie Centrum Okulistyki

    Gdansk, 80-809

  • Gabinet Okulistyczny Prof Edward Wylegala

    Katowice, 40-594

  • SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej

    Krakow, 31-501

Other trials in Poland

United Kingdom4 sites

  • Ayr Hospital

    Ayr, KA6 6DX

  • The Princess Alexandra Eye Pavilion

    Edinburgh, EH3 9HA

  • Frimley Park Hospital

    Frimley, GU16 7UJ

  • Royal Hallamshire Hospita

    Sheffield, S10 2JF

Other trials in United Kingdom

Hungary3 sites

  • Budapest Retina Associates Kft.

    Budapest, 1133

  • Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

    Debrecem, 4032

  • Ganglion Medial Center

    Pécs, 7621

Other trials in Hungary

Netherlands3 sites

  • Academisch Medisch Centrum Universiteit Amsterdam

    Amsterdam, 1105 AZ

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA0

  • Radboud University Nijmegen Medical Centre; Ophthalmology

    Nijmegen, 6525 EX

Other trials in Netherlands

Slovakia3 sites

  • Nemocnica sv. Michala, a.s.

    Bratislava, 81108

  • Fakultna nemocnica Trencin Ocna klinika

    Trenčín, 911 71

  • Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie

    Žilina, 012 07

Other trials in Slovakia

Mexico2 sites

  • Macula Retina Consultores

    Mexico City, 01120

  • Hospital de la Ceguera APEC

    Mexico City, 04030

Other trials in Mexico

Peru2 sites

  • CLINICA RICARDO PALMA; Oftalmologos Contreras

    Lima, 27

  • Clinica Anglo Americana

    Lima, Lima 27

Other trials in Peru

Austria1 site

  • Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde

    Linz, 4021

Other trials in Austria

Denmark1 site

  • Sjællands Universitetshospital, Roskilde; Øjenafdelingen

    Roskilde, 4000

Other trials in Denmark

Switzerland1 site

  • Stadtspital Triemli; Augenklinik

    Zurich, 8063

Other trials in Switzerland

About this study

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

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).

Being tested
Lampalizumab, Sham
Medical subject headings
Geographic Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LampalizumabDrug

    Also called RO5490249

    Participants will receive 10 mg dose of lampalizumab administered intravitreally.

  • ShamOther

    A sham injection is a procedure that mimics an intravitreal injection of lampalizumab.

Study groups in NCT02247479
Study groupRoleWhat they receive
Lampalizumab Once in Every 4 Weeks (Q4W)ExperimentalParticipants will receive 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections for approximately 96 weeks.
Receives: Drug: Lampalizumab
Lampalizumab Once in Every 6 Weeks (Q6W)ExperimentalParticipants will receive 10 mg dose of lampalizumab administered by intravitreal injections for approximately 96 weeks.
Receives: Drug: Lampalizumab
Sham ComparatorSham comparatorParticipants will receive sham comparator Q4W or Q6W for 96 weeks.
Receives: Other: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline, Week 48

  2. 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).

    Measured: Baseline, Week 48

Secondary outcomes (12)

  1. Change From Baseline in Number of Absolute Scotomatous Points as Assessed by Mesopic Micrometry at Week 48

    Scotomatous points were the testing points on microperimetry examination that were centered on the macula and reported a lack of retinal sensitivity within the range tested, a maximum of 68 points were tested within this range. Higher results indicate expansion of absolute scotoma and higher number of abolute scotomatous points. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening.

    Measured: Baseline, Week 48

  2. Change From Baseline in Mean Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48

    Mesopic microperimetry was used to assess macular sensitivity and assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A negative change from baseline indicates a decrease in the mean macular sensitivity; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.

    Measured: Baseline, Week 48

  3. Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Week 48

    BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m). BCVA score testing was performed prior to dilating the eyes. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.

    Measured: Baseline, Week 48

  4. Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week 48

    Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 meters (m). BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The data was collected up to Week 48 instead of Week 96, due to early termination of the study.

    Measured: Week 48

  5. Change From Baseline in Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions at Week 48

    The LLVA was measured by placing a 2.0-log-unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart. The assessment was performed prior to dilating the eyes. LLVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The data was collected up to Week 48 instead of Week 96, due to early termination of the study.

    Measured: Baseline, Week 48

  6. Percentage of Participants With Less Than 15 Letters Loss From Baseline in LLVA Score at Week 48

    Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 m. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.

    Measured: Week 48

  7. Change From Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Charts or Radner Reading Charts at Week 48

    MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the binocular reading speed; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.

    Measured: Baseline, Week 48

  8. Change From Baseline in Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts at Week 48

    MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the monocular reading speed; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.

    Measured: Baseline, Week 48

  9. Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score at Week 48

    NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: near activities, distance activities, general health,general vision, ocular pain, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision and peripheral vision. Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the visual functioning; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.

    Measured: Baseline, Week 48

  10. Change From Baseline in NEI VFQ-25 Near Activity Subscale Score at Week 48

    NEI-VFQ-25 questionnaire included 25 items based on which near activities were measured. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the near visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.

    Measured: Baseline, Week 48

  11. Change From Baseline in NEI VFQ-25 Distance Activity Subscale Score at Week 48

    NEI-VFQ-25 questionnaire included 25 items based on which distance activities were measured. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the distance visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.

    Measured: Baseline, Week 48

  12. Change From Baseline in Mean Functional Reading Independence (FRI) Index at Week 48

    The FRI was an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD participants. It has one total index score. For each FRI Index reading activity performed in the past 7 days, participants were asked about the extent to which they required vision aids, adjustments in the activity, or help from another participant. Mean FRI Index scores range from 1 to 4, with higher scores indicating greater independence. A negative change from baseline indicates a decrease in the FRI; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.

    Measured: Baseline, Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2014 (estimated)
  2. Study start18 Sep 2014
  3. Primary completion29 Jan 2018
  4. Study completion29 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
906 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02247479
Sponsor's protocol ID
GX29176
Other IDs
2014-000107-27, 2014
Acronym
CHROMA
Status last verified
Jun 2019
First submitted
15 Jul 2014
Last updated
26 Jun 2019
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Yoshida K, Zhang M, Pely A, Steffen V, Gao SS, Chakravarthy U, Rabe C, Fauser S, Ferrara D, Cukras C. Structure-Function Correlations Using Artificial Intelligence-Extracted Retinal Layer Attenuation Measurements in OCT in Eyes with Geographic Atrophy. Ophthalmol Sci. 2026 Jul 10;6(9):101322. doi: 10.1016/j.xops.2026.101322. eCollection 2026 Sep.

    PubMed 42668567

  • 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.

    PubMed 39758130

  • Cluceru 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.

    PubMed 39102242

  • Bressler 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.

    PubMed 38900484

  • Chang 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.

    PubMed 37869030

  • Tzoumas 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.

    PubMed 37314061

  • 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.

    PubMed 33383315

  • 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.

    PubMed 32199866

  • 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.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lampalizumab in people with Geographic Atrophy, run by Hoffmann-La Roche at 145 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 145 sites in United States, Canada, Germany, Spain, France and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48 (time frame: Baseline, Week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02247479, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2019.

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