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

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 Comparator

• Study Type: Interventional
• Enrollment (Actual): 975
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Capital Federal, Argentina, C1120AAN
    • Oftalmos
  • Capital Federal, Argentina, C1122AAI
    • Instituto de la Vision
  • Florencio Varela, Argentina, B1888AAE
    • Hospital El Cruce
• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4101
      • Queensland Eye Institute
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Adelaide Eye and Retina Centre
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Vision Eye Institute Eastern
    • East Melbourne, Victoria, Australia, 3002
      • Royal Victorian Eye and Ear Hospital
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • The Lions Eye Institute
• Austria
  • Wien, Austria, 1090
    • Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie
• Belgium
  • Bruxelles, Belgium, 1020
    • CHU Brugmann (Victor Horta)
  • Leuven, Belgium, 3000
    • UZ Leuven Sint Rafael
• Denmark
  • Glostrup, Denmark, 2600
    • Glostrup Hospital, Øjenafdelingen, Forskningsafsnit Ø37
• France
  • Bordeaux, France, 33000
    • Hopital Pellegrin; Ophtalmologie
  • Dijon, France, 21079
    • CHU Bocage; Ophtalmologie
  • Lyon cedex, France, 69317
    • Hopital de la croix rousse; Ophtalmologie
  • Marseille, France, 13008
    • Centre Paradis Monticelli; Ophtalmologie
  • Nantes, France, 44093
    • Hopital Hotel Dieu Et Hme; Clinique Ophtalmologique
  • Paris, France, 75012
    • CHNO des Quinze Vingts; Ophtalmologie
• Germany
  • Freiburg, Germany, 79106
    • Universitätsklinikum Freiburg, Klinik für Augenheilkunde
  • Heidelberg, Germany, 69120
    • Universitätsklinik Heidelberg; Augenklinik
  • Ludwigshafen, Germany, 67063
    • Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik
  • Mainz, Germany, 55131
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik
  • München, Germany, 80336
    • LMU Klinikum der Universitat, Augenklinik
  • München, Germany, 81675
    • Klinikum rechts der Isar der TU München; Augenklinik
  • Regensburg, Germany, 93053
    • Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde
  • Tuebingen, Germany, 72076
    • Universitätsklinikum Tübingen
• Hungary
  • Budapest, Hungary, 1076
    • Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem AOK, Szemeszeti Klinika
  • Pécs, Hungary, 7621
    • Ganglion Medial Center
• Italy
  • Liguria
    • Genova, Liguria, Italy, 16132
      • UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA
  • Lombardia
    • Milano, Lombardia, Italy, 20157
      • ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)
    • Milano, Lombardia, Italy, 20132
      • Irccs Ospedale San Raffaele;U.O. Oculistica
  • Piemonte
    • Torino, Piemonte, Italy, 10122
      • A.S.L. to1 Presidio Ospedaliero Sperino Oftalmico
  • Toscana
    • Firenze, Toscana, Italy, 50134
      • Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica
  • Veneto
    • Udine, Veneto, Italy, 33100
      • A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica
• Mexico
  • Mexico City, Mexico, 06030
    • Hospital Nuestra Señora de La Luz
  • Monterrey, Mexico, 64040
    • Hospital Universitario de Monterrey
  • Querétaro, Mexico, 76090
    • Instituto Mexicano de Oftalmologia I.A.P.
• Netherlands
  • Nijmegen, Netherlands, 6525 EX
    • Radboud University Nijmegen Medical Centre; Ophthalmology
  • Rotterdam, Netherlands, 3015 GD
    • Erasmus Medisch Centrum
• Peru
  • Lima, Peru, 27
    • Mácula D&T
  • Lima, Peru, 27
    • TG Laser Oftalmica
  • Lima, Peru, 33
    • Centro de Investigacion Oftalmolaser
• Poland
  • Bydgoszcz, Poland, 85-631
    • OFTALMIKA Sp. z o.o
  • Bytom, Poland, 41-902
    • Szpital Specjalistyczny nr 1; Oddzial Okulistyki
  • Wrocław, Poland, 50-556
    • Uniwersytecki Szpital Kliniczny; Klinika Okulistyki
  • Łódź, Poland, 91-134
    • Klinika Okulistyczna Jasne Błonia
• Portugal
  • Coimbra, Portugal, 3030-163
    • Espaco Medico Coimbra
  • Coimbra, Portugal, 3000-548
    • AIBILI - Association for Innovation and Biomedical Research on Light
  • Lisboa, Portugal, 1649-035
    • Hospital de Santa Maria; Servico de Oftalmologia
  • Porto, Portugal, 4200-319
    • Hospital de Sao Joao; Servico de Oftalmologia
• Russian Federation
  • Kazan, Russian Federation, 420012
    • SAHI "Republic clinical ophthalmological hospial of Ministry of Heal of Tatarstan Republic"
  • Moscow, Russian Federation, 119435
    • FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences
  • Samara, Russian Federation, 443068
    • St. Educ.Inst. of High Prof.Education "Samara State Medical University"; Chair of ophathalmology
• Slovakia
  • Banska Bystrica, Slovakia, 975 17
    • FNsP F. D. Roosevelta Banska Bystrica, II.Ocna klinika SZU
  • Bratislava, Slovakia, 851 07
    • Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda Ocna klinika SZU a UNB
• Spain
  • Albacete, Spain, 02006
    • Hospital Perpetuo Socorro; Servicio de Oftalmología
  • Barcelona, Spain, 08035
    • Instituto de Microcirugia Ocular
  • Madrid, Spain, 28002
    • VISSUM Madrid Santa Hortensia
  • Madrid, Spain, 28040
    • Hospital Universitario Clínico San Carlos; Servicio de Oftalmologia
  • Valencia, Spain, 46026
    • Hospital Universitario la Fe: Servicio de Oftalmologia
  • LA Coruña
    • Santiago de Compostela, LA Coruña, Spain, 15706
      • Instituto Oftalmologico Gomez Ulla
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universitaria de Navarra; Servicio de Oftalmologia
• Sweden
  • Stockholm, Sweden, SE-112 82
    • St Eriks Eye Hospital
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern, Universitätsklinik für Augenheilkunde
  • Binningen, Switzerland, 4102
    • Vista Klinik Binningen
• Turkey
  • Ankara, Turkey, 06340
    • Ankara University Medical Faculty; Department of Ophthalmology
  • Ankara, Turkey, 06490
    • Ankara Baskent University Medical Faculty; Department of Ophthalmology
  • Ankara, Turkey, 06100
    • Hacettepe University Medical Faculty; Department of Ophthalmology
  • Istanbul, Turkey, 34093
    • Istanbul University Istanbul Medical Faculty; Department of Ophthalmology
  • Izmir, Turkey, 35100
    • Ege University Medical Faculty; Department of Ophthalmology
  • Izmir, Turkey, 35340
    • Dokuz Eylul University Medical Faculty; Department of Ophthalmology
• United Kingdom
  • Belfast, United Kingdom, BT12 6BA
    • Royal Victoria Hospital
  • Bradford, United Kingdom, BD9 6RJ
    • Bradford Royal Infirmary
  • Bristol, United Kingdom, BS1 2LX
    • Bristol Eye Hospital
  • Cardiff, United Kingdom, CF14 4XW
    • University Hospital of Wales
  • Gloucestershire, United Kingdom, GL1 3NN
    • Gloucestershire Hospitals NHS Foundation Trust
  • Liverpool, United Kingdom, L7 8XP
    • Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre
  • London, United Kingdom, EC1V 2PD
    • Moorfields Eye Hospital NHS Foundation Trust
  • London, United Kingdom, SE5 9RS
    • Kings College Hospital
  • Manchester, United Kingdom, M13 9WL
    • Macular Treatment Centre; Royal Eye Hospital
  • Middx, United Kingdom, UB8 3NN
    • Hillingdon Hospital
  • Newcastle upon Tyne, United Kingdom, NE1 4LP
    • Royal Victoria Infirmary
  • Southampton, United Kingdom, SO16 6YD
    • Southampton General Hospital
  • Wolverhampton, United Kingdom, WV10 0QP
    • The Royal Wolverhampton Hospitals NHS Trust
  • York, United Kingdom, YO31 8HE
    • The York Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85020
      • Associated Retina Consultants
    • Tucson, Arizona, United States, 85750
      • Retina Associates Southwest PC
  • California
    • Fullerton, California, United States, 92835
      • Retina Consultants of Orange County
    • La Jolla, California, United States, 92093-0946
      • UCSD Shiley Eye Center
    • Los Angeles, California, United States, 90095-7000
      • Jules Stein Eye Institute/ UCLA
    • Mountain View, California, United States, 94040
      • N CA Retina Vitreous Assoc
    • Palo Alto, California, United States, 94303
      • Byers Eye Insitute at Stanford
    • Poway, California, United States, 92064
      • Retina Consultants, San Diego
    • Sacramento, California, United States, 95817
      • University of California, Davis, Eye Center
    • Sacramento, California, United States, 95841
      • Retinal Consultants Med Group
    • Santa Barbara, California, United States, 93103
      • California Retina Consultants
    • Walnut Creek, California, United States, 94598
      • Bay Area Retina Associates
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Retina Consultants of Southern
    • Golden, Colorado, United States, 80401
      • Colorado Retina Associates, PC
  • Connecticut
    • Hamden, Connecticut, United States, 06518
      • New England Retina Associates
    • Waterford, Connecticut, United States, 06385
      • Retina Group of New England
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Retina Group of Florida
    • Fort Myers, Florida, United States, 33907
      • Retina Health Center
    • Naples, Florida, United States, 34103
      • Bascom Palmer 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, 33612
      • University of South Florida
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory University
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Wolfe Eye Clinic
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Vitreo Retinal Consultants
  • Kentucky
    • Paducah, Kentucky, United States, 42001
      • Paducah Retinal Center
  • Maryland
    • Baltimore, Maryland, United States, 21209
      • The Retina Care Center
    • Baltimore, Maryland, United States, 21287
      • Wilmer Eye Institute
    • Chevy Chase, Maryland, United States, 20815
      • Retina Group of Washington
    • Towson, Maryland, United States, 21204
      • Retina Specialists
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Mass Eye and Ear Infirmary
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • University of Michigan, Kellogg Eye Center
    • Detroit, Michigan, United States, 48201-1423
      • Kresge Eye Institute
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Vitreoretinal Surgery
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Midwest Vision Research Foundation
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • UNMC Truhlsen Eye Institute
  • Nevada
    • Reno, Nevada, United States, 89502
      • Sierra Eye Associates
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08034
      • Mid Atlantic Retina - Wills Eye Hospital
    • Northfield, New Jersey, United States, 08225
      • Retinal & Ophthalmic Cons PC
    • Teaneck, New Jersey, United States, 07666
      • Retina Associates of NJ
  • New York
    • New York, New York, United States, 10022
      • Vitreous-Retina-Macula
    • New York, New York, United States, 10021
      • New York Weil Cornell Med Ctr
    • Rochester, New York, United States, 14620
      • Retina Assoc of Western NY
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Western Carolina Retinal Associate PA
    • Charlotte, North Carolina, United States, 28210
      • Char Eye Ear &Throat Assoc
    • Durham, North Carolina, United States, 27710
      • Duke University Eye Center; Vitreoretinal
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Cincinnati Eye Institute
    • Columbus, Ohio, United States, 43212
      • OSU Eye Physicians & Surgeons
  • Oregon
    • Ashland, Oregon, United States, 97520
      • Retina & Vitreous Center of Southern Oregon
    • Portland, Oregon, United States, 97221
      • Retina Northwest
    • Portland, Oregon, United States, 97239
      • Oregon HSU; Casey Eye Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Mid Atlantic Retina
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Ophthalmic & Orbital
  • South Carolina
    • Charleston, South Carolina, United States
      • MUSC Storm Eye Institute
    • Florence, South Carolina, United States, 29501
      • Palmetto Retina Center
    • Ladson, South Carolina, United States, 29456
      • Charleston Neuroscience Inst
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Eye Institute
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Southeastern Retina Associates Chattanooga
    • Germantown, Tennessee, United States, 38138
      • Charles Retina Institution
  • Texas
    • Abilene, Texas, United States, 79606
      • Retina Res Institute of Texas
    • Dallas, Texas, United States, 75231
      • Texas Retina Associates
    • Houston, Texas, United States, 77030
      • Retina Consultants of Houston
    • Temple, Texas, United States, 76504
      • Scott and White Hospital
    • The Woodlands, Texas, United States, 77384
      • Retina Consultants of Houston
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Univ of Virginia Ophthalmology
  • Washington
    • Bellevue, Washington, United States, 98004
      • Vitreoretinal Associates of Washington

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:

• Participants aged greater than or equal to (>/=) 50 years
• 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 (e.g., 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 mg (milligrams) dose of lampalizumab by intravitreal injection, Q4W, starting at the Day 1 visit for approximately 92 weeks.	Drug: Lampalizumab; 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 by intravitreal injection, Q6W, starting at the Day 1 visit for approximately 90 weeks.	Drug: Lampalizumab; 10 mg dose of lampalizumab administered intravitreally.; Other Names: RO5490249
Sham Comparator: Sham Comparator; Participants will receive sham comparator, Q4W, starting at the Day 1 visit for approximately 92 weeks or Q6W, starting at the Day 1 visit for approximately 90 weeks.	Other: Sham Comparator; 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 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
Change From Baseline in Geographic Atropy (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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change From Baseline in Number of Absolute Scotomatous Points Assessed by Mesopic Microperimetry 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. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.	Baseline, Week 48
Change From Baseline in 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. Data were 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). A decrease in the VA score indicates a worsening in visual acuity. BCVA score testing was performed prior to dilating the eyes. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. 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.	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). Data were 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 low luminance visual acuity 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. A negative change from baseline indicates a decrease in the visual acuity; disease worsening. Data were 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. Data were 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. Data were 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 reading acuity and reading speed of normal and low-vision participants. 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. Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. Reading test was stopped when reading time was longer than 20 seconds or when 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 or total score is the average of items contributing to the score. For each subscale and total score the score range is 0 to 100 with a higher score representing better functioning. A negative change from baseline indicates a decrease in the visual functioning; disease worsening. Data were 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

• 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): October 6, 2014
• Primary Completion (Actual): January 23, 2018
• Study Completion (Actual): January 23, 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): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 14, 2019
• Last Verified: October 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: GX29185; 2014-000106-35 (EudraCT Number)