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

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).

Study Overview

• Status: Terminated
• Conditions: Geographic Atrophy
• Intervention / Treatment: Drug: Lampalizumab; Other: Sham

• Study Type: Interventional
• Enrollment (Actual): 906
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1015ABO
    • Organización Médica de Investigación
  • Caba, Argentina, 1023
    • Fundacion Zambrano
  • Mendoza, Argentina, M5500GGK
    • Oftar
  • Rosario, Argentina, S2000CTC
    • Microcirugía Ocular S.A
  • Rosario, Argentina, S2000DLA
    • Grupo Laser Vision
• Australia
  • New South Wales
    • Albury, New South Wales, Australia, 2640
      • Eyeclinic Albury Wodonga
    • Parramatta, New South Wales, Australia, 2150
      • Marsden Eye Research Centre
    • Sydney, New South Wales, Australia, 2000
      • Save Sight Institute
    • Westmead, New South Wales, Australia, 2145
      • Sydney West Retina
• Austria
  • Linz, Austria, 4021
    • Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde
• Belgium
  • Bruxelles, Belgium, 1020
    • CHU Brugmann (Victor Horta)
  • Gent, Belgium, 9000
    • UZ Gent
  • Leuven, Belgium, 3000
    • UZ Leuven Sint Rafael
  • Liège, Belgium, 4000
    • CHU Sart-Tilman
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 0C8
      • Calgary Retina Consultants
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 1Z4
      • University of British Columbia
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • QEII - HSC Department of Ophthalmology
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • University of Ottawa Eye Institute
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M5G 2C4
      • St. Michael's Hospital
    • Toronto, Ontario, Canada, M5T 2S8
      • University Health Network Toronto Western Hospital
  • Quebec
    • Boisbriand, Quebec, Canada, J7H 1S6
      • Institut De L'Oeil Des Laurentides
• Denmark
  • Roskilde, Denmark, 4000
    • Sjællands Universitetshospital, Roskilde; Øjenafdelingen
• France
  • Creteil, France, 94010
    • Chi De Creteil; Ophtalmologie
  • Paris, France, 75006
    • Centre Odeon; Exploration Ophtalmologique
  • Paris, France, 75010
    • Hopital Lariboisiere; Ophtalmologie
  • Paris, France, 75015
    • Centre Ophtalmologique; Imagerie et laser
  • Paris, France, 75651
    • Ch Pitie Salpetriere; Ophtalmologie
  • Poitiers, France, 86021
    • CHU Poitiers - CHR La Miletrie; Ophtalmologie
• Germany
  • Bonn, Germany, 53127
    • Universitäts-Augenklinik Bonn
  • Göttingen, Germany, 37075
    • Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover, Klinik für Augenheilkunde
  • Köln, Germany, 50937
    • Universitätsklinikum Köln; Augenklinik
  • Lübeck, Germany, 23538
    • Universitätskliniikum Schleswig-Holstein, Campus Lübeck, Klinik für Augenheilkunde
  • Münster, Germany, 48145
    • Augenabteilung am St. Franziskus-Hospital
  • Münster, Germany, 48149
    • Universitätsklinikum Münster; Augenheilkunde
• Hungary
  • Budapest, Hungary, 1133
    • Budapest Retina Associates Kft.
  • Debrecem, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
  • Pecs, Hungary, 7621
    • Ganglion Medial Center
• Italy
  • Lazio
    • Roma, Lazio, Italy, 00133
      • Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche
    • Roma, Lazio, Italy, 00198
      • Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
  • Lombardia
    • Milano, Lombardia, Italy, 20100
      • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica
  • Sardegna
    • Sassari, Sardegna, Italy, 07100
      • Azienda Ospedaliero Universitaria Di Sassari;U.O. Oculistica
• Mexico
  • Mexico, D.F., Mexico, 01120
    • Macula Retina Consultores
  • Mexico, D.F., Mexico, 04030
    • Hospital de la Ceguera APEC
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Academisch Medisch Centrum Universiteit Amsterdam
  • Leiden, Netherlands, 2333 ZA0
    • Leids Universitair Medisch Centrum
  • Nijmegen, Netherlands, 6525 EX
    • Radboud University Nijmegen Medical Centre; Ophthalmology
• Peru
  • Lima, Peru, Lima 27
    • Clínica Anglo Americana
  • Lima, Peru, 27
    • CLINICA RICARDO PALMA; Oftalmologos Contreras
• Poland
  • Bydgoszcz, Poland, 85-631
    • OFTALMIKA Sp. z o.o
  • Gdańsk, Poland, 80-809
    • Optimum Profesorskie Centrum Okulistyki
  • Katowice, Poland, 40-594
    • Gabinet Okulistyczny Prof Edward Wylegala
  • Krakow, Poland, 31-501
    • SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej
• Slovakia
  • Bratislava, Slovakia, 81108
    • Nemocnica sv. Michala, a.s.
  • Trencin, Slovakia, 911 71
    • Fakultna nemocnica Trencin Ocna klinika
  • Zilina, Slovakia, 012 07
    • Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie
• Spain
  • Alicante, Spain, 03016
    • VISSUM Instituto Oftalmológico de Alicante
  • Barcelona, Spain, 08022
    • Institut de la Macula i la retina
  • Valencia, Spain, 46015
    • FISABIO. Fundación Oftalmologica del Mediterraneo
  • Valladolid, Spain, 47012
    • Hospital Universitario Rio Hortega; Servicio de Oftalmologia
  • Barcelona
    • Hospitalet De Llobregat, Barcelona, Spain, 8907
      • Hospital Universitari de Bellvitge; Servicio de Oftalmologia
    • San Cugat Del Valles, Barcelona, Spain, 08195
      • Hospital General de Catalunya
  • Guipuzcoa
    • Bilbao, Guipuzcoa, Spain, 48006
      • Instituto Clinico Quirurgico de Oftalmologia - ICQO
• Switzerland
  • Zürich, Switzerland, 8063
    • Stadtspital Triemli; Augenklinik
• United Kingdom
  • AYR, United Kingdom, KA6 6DX
    • Ayr Hospital
  • Edinburgh, United Kingdom, EH3 9HA
    • The Princess Alexandra Eye Pavilion
  • Frimley, United Kingdom, GU16 7UJ
    • Frimley Park Hospital
  • Sheffield, United Kingdom, S10 2JF
    • Royal Hallamshire Hospita
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Uni of Alabama At Birmingham Clinical Research Unit
  • Arizona
    • Phoenix, Arizona, United States, 85014
      • Retinal Research Institute, LLC
    • Tucson, Arizona, United States, 85704
      • Retina Centers P.C.
  • California
    • Bakersfield, California, United States, 93309
      • California Retina Consultants
    • Beverly Hills, California, United States, 90211
      • Retina-Vitreous Associates Medical Group
    • Irvine, California, United States, 92697-4375
      • The Gavin Herbert Eye Institute - UC, Irvine
    • Los Angeles, California, United States, 90095-7000
      • Jules Stein Eye Institute/ UCLA
    • Oakland, California, United States, 94609
      • East Bay Retina Consultants
    • Palm Desert, California, United States, 92211
      • Southern CA Desert Retina Cons
    • San Francisco, California, United States, 94107
      • W Coast Retina Med Group Inc
    • San Francisco, California, United States, 94143
      • UCSF; Ophthalmology
    • Santa Ana, California, United States, 92705
      • Orange County Retina Med Group
    • Santa Barbara, California, United States, 93103
      • California Retina Consultants
  • Florida
    • Boynton Beach, Florida, United States, 33426
      • Florida Eye Microsurgical Inst
    • Fort Myers, Florida, United States, 33912
      • National Ophthalmic Research Institute
    • Melbourne, Florida, United States, 32901
      • Florida Eye Associates
    • Palm Beach Gardens, Florida, United States, 33410
      • Retina Care Specialists
    • Palm Beach Gardens, Florida, United States, 33418
      • Bascom Palmer Eye Institute
    • Pensacola, Florida, United States, 32503
      • Retina Specialty Institute
    • Plantation, Florida, United States, 33324
      • Fort Lauderdale Eye Institute
    • Saint Petersburg, Florida, United States, 33711
      • Retina Vitreous Assoc of FL
    • Tallahassee, Florida, United States, 32308
      • Southern Vitreoretinal Assoc
    • Tampa, Florida, United States, 33609
      • Retina Associates of Florida, LLC
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Southeast Retina Center
    • Marietta, Georgia, United States, 30060
      • Georgia Retina PC
  • Hawaii
    • 'Aiea, Hawaii, United States, 96701
      • Retina Consultants Of Hawaii
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medical Group/Northwestern University
    • Oak Forest, Illinois, United States, 60452
      • University Retina and Macula Associates, PC
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • Midwest Eye Institute Northside
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Wolfe Eye Clinic
  • Kansas
    • Shawnee Mission, Kansas, United States, 66204
      • Retina Associates
  • Kentucky
    • Lexington, Kentucky, United States, 02421
      • Lahey Clinic Med Ctr
    • Lexington, Kentucky, United States, 40509
      • Retina Associates of Kentucky
  • Maine
    • Portland, Maine, United States, 04101
      • Maine Eye Center
  • Maryland
    • Towson, Maryland, United States, 21204
      • Retina Specialists
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Ophthalmic Consultants of Boston
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center Research
    • Worcester, Massachusetts, United States, 01605
      • Vitreo-Retinal Associates, PC
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Vitreo-Retinal Associates
    • Jackson, Michigan, United States, 49202
      • Specialty Eye Institute
    • Royal Oak, Michigan, United States, 48073
      • Assoc Retinal Consultants PC
    • Southfield, Michigan, United States, 48034
      • Retina Consultants of Michigan
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Eye Surgical Associates
  • Nevada
    • Las Vegas, Nevada, United States, 89123
      • Retina Consultants of Nevada
  • New Jersey
    • Bloomfield, New Jersey, United States, 07003
      • Retina Center of New Jersey
    • Edison, New Jersey, United States, 08820
      • New Jersey Retina Research Foundation
    • Lawrenceville, New Jersey, United States, 08648
      • Delaware Valley Retina Assoc
  • New York
    • Hauppauge, New York, United States, 11788
      • Long Is. Vitreoretinal Consult
    • Lynbrook, New York, United States, 11563
      • Opthalmic Consultants of LI
    • New York, New York, United States, 10003
      • New York Eye & Ear Infirmary
    • Orchard Park, New York, United States, 14127
      • Retina Consultants of Western New York
    • Syracuse, New York, United States, 13224
      • Retina Vit Surgeons/Central NY
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Western Carolina Retinal Associate PA
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health Eye Centre
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Retina Assoc of Cleveland Inc
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation; Cole Eye Institute
  • Pennsylvania
    • Monroeville, Pennsylvania, United States, 15146
      • Retina Vitreous Consultants
    • West Mifflin, Pennsylvania, United States, 15122
      • Associates in Ophthalmology
  • South Carolina
    • Ladson, South Carolina, United States, 29456
      • Charleston Neuroscience Inst
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt
    • Nashville, Tennessee, United States, 37203
      • Tennessee Retina PC.
  • Texas
    • Abilene, Texas, United States, 79606
      • Retina Res Institute of Texas
    • Arlington, Texas, United States, 76012
      • Texas Retina Associates
    • Austin, Texas, United States, 78705
      • Austin Retina Associates
    • Austin, Texas, United States, 78705
      • Retina Research Center
    • Dallas, Texas, United States, 75390
      • UT Southwestern MC at Dallas
    • McAllen, Texas, United States, 78503
      • Valley Retina Institute P.A.
    • Willow Park, Texas, United States, 76087
      • Strategic Clinical Research Group, LLC
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Retina Associates of Utah
  • Virginia
    • Richmond, Virginia, United States, 23226
      • Eye Surgeons of Richmond Inc. dba Virginia Eye Institute
    • Richmond, Virginia, United States, 23235
      • Retina Institute of Virginia
    • Warrenton, Virginia, United States, 20186
      • Virginia Retina Center
  • Washington
    • Silverdale, Washington, United States, 98383
      • Retina Center Northwest
    • Spokane, Washington, United States, 99204
      • Spokane Eye Clinical Research
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Eye Institute
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lampalizumab Once in Every 4 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 Names: 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 48
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.	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	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.	Baseline, Week 48
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.	Week 48
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.	Baseline, Week 48
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.	Week 48
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.	Baseline, Week 48
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.	Baseline, Week 48
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.	Baseline, Week 48
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.	Baseline, Week 48
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.	Baseline, Week 48
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.	Baseline, Week 48

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2014
• Primary Completion (Actual): January 29, 2018
• Study Completion (Actual): January 29, 2018

Study Registration Dates

• First Submitted: July 15, 2014
• First Submitted That Met QC Criteria: September 19, 2014
• First Posted (Estimate): September 25, 2014

Study Record Updates

• Last Update Posted (Actual): June 26, 2019
• Last Update Submitted That Met QC Criteria: June 17, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Pathological Conditions, Anatomical; Macular Degeneration; Geographic Atrophy; Atrophy
• Other Study ID Numbers: GX29176; 2014-000107-27 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No