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Geographic AtrophyPhase 3SPECTRINCT02247531

A Study Investigating the Safety and Efficacy 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 153 sites in 22 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
975 participants
Where
153 sitesin 22 countries
Study dates
6 Oct 2014to 23 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

  • 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

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 (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

Trial locations and contacts

153 sites in 22 countries.

153 sites in 22 countries

United States67 sites

  • Retina Res Institute of Texas

    Abilene, Texas, 79606

  • University of Michigan, Kellogg Eye Center

    Ann Arbor, Michigan, 48105

  • Western Carolina Retinal Associate PA

    Asheville, North Carolina, 28803

  • Retina & Vitreous Center of Southern Oregon

    Ashland, Oregon, 97520

  • Emory University

    Atlanta, Georgia, 30329

  • University of Colorado

    Aurora, Colorado, 80045

  • The Retina Care Center

    Baltimore, Maryland, 21209

  • Wilmer Eye Institute

    Baltimore, Maryland, 21287

  • Vitreoretinal Associates of Washington

    Bellevue, Washington, 98004

  • Mass Eye and Ear Infirmary

    Boston, Massachusetts, 02114

  • MUSC Storm eye institute

    Charleston, South Carolina

  • Char Eye Ear &Throat Assoc

    Charlotte, North Carolina, 28210

  • Univ of Virginia Ophthalmology

    Charlottesville, Virginia, 22903

  • Southeastern Retina Associates Chattanooga

    Chattanooga, Tennessee, 37421

  • Mid Atlantic Retina - Wills Eye Hospital

    Cherry Hill, New Jersey, 08034

  • Midwest Vision Research Foundation

    Chesterfield, Missouri, 63017

  • Retina Group of Washington

    Chevy Chase, Maryland, 20815

  • Cincinnati Eye Institute

    Cincinnati, Ohio, 45242

  • Retina Consultants of Southern

    Colorado Springs, Colorado, 80909

  • OSU Eye Physicians & Surgeons

    Columbus, Ohio, 43212

  • Texas Retina Associates

    Dallas, Texas, 75231

  • Kresge Eye Institute

    Detroit, Michigan, 48201-1423

  • Duke University Eye Center; Vitreoretinal

    Durham, North Carolina, 27710

  • Vitreoretinal Surgery

    Edina, Minnesota, 55435

  • Palmetto Retina Center

    Florence, South Carolina, 29501

  • Retina Group of Florida

    Fort Lauderdale, Florida, 33308

  • Retina Health Center

    Fort Myers, Florida, 33907

  • Retina Consultants of Orange County

    Fullerton, California, 92835

  • Charles Retina Institution

    Germantown, Tennessee, 38138

  • Colorado Retina Associates, PC

    Golden, Colorado, 80401

  • New England Retina Associates

    Hamden, Connecticut, 06518

  • Retina Consultants of Houston

    Houston, Texas, 77030

  • UCSD Shiley Eye Center

    La Jolla, California, 92093-0946

  • Charleston Neuroscience Inst

    Ladson, South Carolina, 29456

  • Jules Stein Eye Institute/ UCLA

    Los Angeles, California, 90095-7000

  • N CA Retina Vitreous Assoc

    Mountain View, California, 94040

  • Bascom Palmer Eye Institute

    Naples, Florida, 34103

  • New York Weil Cornell Med Ctr

    New York, New York, 10021

  • Vitreous-Retina-Macula

    New York, New York, 10022

  • Retinal & Ophthalmic Cons PC

    Northfield, New Jersey, 08225

  • UNMC Truhlsen Eye Institute

    Omaha, Nebraska, 68105

  • Paducah Retinal Center

    Paducah, Kentucky, 42001

  • Byers Eye Insitute at Stanford

    Palo Alto, California, 94303

  • Mid Atlantic Retina

    Philadelphia, Pennsylvania, 19107

  • Associated Retina Consultants

    Phoenix, Arizona, 85020

  • Allegheny Ophthalmic & Orbital

    Pittsburgh, Pennsylvania, 15212

  • Retina Northwest

    Portland, Oregon, 97221

  • Oregon HSU; Casey Eye Institute

    Portland, Oregon, 97239

  • Retina Consultants, San Diego

    Poway, California, 92064

  • Black Hills Eye Institute

    Rapid City, South Dakota, 57701

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Retina Assoc of Western NY

    Rochester, New York, 14620

  • University of California, Davis, Eye Center

    Sacramento, California, 95817

  • Retinal Consultants Med Group

    Sacramento, California, 95841

  • California Retina Consultants

    Santa Barbara, California, 93103

  • Retina Vitreous Assoc of FL

    St. Petersburg, Florida, 33711

  • Southern Vitreoretinal Assoc

    Tallahassee, Florida, 32308

  • University of South Florida

    Tampa, Florida, 33612

  • Retina Associates of NJ

    Teaneck, New Jersey, 07666

  • Scott and White Hospital

    Temple, Texas, 76504

  • Retina Consultants of Houston

    The Woodlands, Texas, 77384

  • Retina Specialists

    Towson, Maryland, 21204

  • Retina Associates Southwest PC

    Tucson, Arizona, 85750

  • Bay Area Retina Associates

    Walnut Creek, California, 94598

  • Retina Group of New England

    Waterford, Connecticut, 06385

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266

  • Vitreo Retinal Consultants

    Wichita, Kansas, 67214

Other trials in United States

United Kingdom14 sites

  • Royal Victoria Hospital

    Belfast, BT12 6BA

  • Bradford Royal Infirmary

    Bradford, BD9 6RJ

  • Bristol Eye Hospital

    Bristol, BS1 2LX

  • University Hospital of Wales

    Cardiff, CF14 4XW

  • Gloucestershire Hospitals NHS Foundation Trust

    Gloucestershire, GL1 3NN

  • Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre

    Liverpool, L7 8XP

  • Moorfields Eye Hospital NHS Foundation Trust

    London, EC1V 2PD

  • Kings College Hospital

    London, SE5 9RS

  • Macular Treatment Centre; Royal Eye Hospital

    Manchester, M13 9WL

  • Hillingdon Hospital

    Middx, UB8 3NN

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

  • Southampton General Hospital

    Southampton, SO16 6YD

  • The Royal Wolverhampton Hospitals NHS Trust

    Wolverhampton, WV10 0QP

  • The York Hospital

    York, YO31 8HE

Other trials in United Kingdom

Germany8 sites

  • Universitätsklinikum Freiburg, Klinik für Augenheilkunde

    Freiburg im Breisgau, 79106

  • Universitätsklinik Heidelberg; Augenklinik

    Heidelberg, 69120

  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik

    Ludwigshafen, 67063

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik

    Mainz, 55131

  • LMU Klinikum der Universität, Augenklinik

    München, 80336

  • Klinikum rechts der Isar der TU München; Augenklinik

    München, 81675

  • Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde

    Regensburg, 93053

  • Universitätsklinikum Tübingen

    Tübingen, 72076

Other trials in Germany

Spain7 sites

  • Hospital Perpetuo Socorro; Servicio de Oftalmología

    Albacete, 02006

  • Instituto de microcirugia ocular

    Barcelona, 08035

  • VISSUM Madrid Santa Hortensia

    Madrid, 28002

  • Hospital Universitario Clínico San Carlos; Servicio de Oftalmologia

    Madrid, 28040

  • Clinica Universitaria de Navarra; Servicio de Oftalmologia

    Pamplona, Navarre, 31008

  • Instituto Oftalmologico Gomez Ulla

    Santiago de Compostela, LA Coruña, 15706

  • Hospital Universitario la Fe: Servicio de Oftalmologia

    Valencia, 46026

Other trials in Spain

France6 sites

  • Hopital Pellegrin; Ophtalmologie

    Bordeaux, 33000

  • CHU Bocage; Ophtalmologie

    Dijon, 21079

  • Hopital de la croix rousse; Ophtalmologie

    Lyon, 69317

  • Centre Paradis Monticelli; Ophtalmologie

    Marseille, 13008

  • Hopital Hotel Dieu Et Hme; Clinique Ophtalmologique

    Nantes, 44093

  • CHNO des Quinze Vingts; Ophtalmologie

    Paris, 75012

Other trials in France

Italy6 sites

  • Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica

    Florence, Tuscany, 50134

  • UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA

    Genoa, Liguria, 16132

  • Irccs Ospedale San Raffaele;U.O. Oculistica

    Milan, Lombardy, 20132

  • ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

    Milan, Lombardy, 20157

  • A.S.L. to1 Presidio Ospedaliero Sperino Oftalmico

    Turin, Piedmont, 10122

  • A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica

    Udine, Veneto, 33100

Other trials in Italy

Turkey (Türkiye)6 sites

  • Hacettepe University Medical Faculty; Department of Ophthalmology

    Ankara, 06100

  • Ankara University Medical Faculty; Department of Ophthalmology

    Ankara, 06340

  • Ankara Baskent University Medical Faculty; Department of Ophthalmology

    Ankara, 06490

  • Istanbul University Istanbul Medical Faculty; Department of Ophthalmology

    Istanbul, 34093

  • Ege University Medical Faculty; Department of Ophthalmology

    Izmir, 35100

  • Dokuz Eylul University Medical Faculty; Department of Ophthalmology

    Izmir, 35340

Other trials in Turkey (Türkiye)

Australia5 sites

  • Adelaide Eye and Retina Centre

    Adelaide, South Australia, 5000

  • Vision Eye Institute Eastern

    Box Hill, Victoria, 3128

  • Queensland Eye Institute

    Brisbane, Queensland, 4101

  • Royal Victorian Eye and Ear Hospital

    East Melbourne, Victoria, 3002

  • The Lions Eye Institute

    Nedlands, Western Australia, 6009

Other trials in Australia

Poland4 sites

  • OFTALMIKA Sp. z o.o

    Bydgoszcz, 85-631

  • Szpital Specjalistyczny nr 1; Oddzial Okulistyki

    Bytom, 41-902

  • Klinika Okulistyczna Jasne Błonia

    Lodz, 91-134

  • Uniwersytecki Szpital Kliniczny; Klinika Okulistyki

    Wroclaw, 50-556

Other trials in Poland

Portugal4 sites

  • AIBILI - Association for Innovation and Biomedical Research on Light

    Coimbra, 3000-548

  • Espaco Medico Coimbra

    Coimbra, 3030-163

  • Hospital de Santa Maria; Servico de Oftalmologia

    Lisbon, 1649-035

  • Hospital de Sao Joao; Servico de Oftalmologia

    Porto, 4200-319

Other trials in Portugal

Argentina3 sites

  • Oftalmos

    Capital Federal, C1120AAN

  • Instituto de la Vision

    Capital Federal, C1122AAI

  • Hospital El Cruce

    San Juan Bautista, B1888AAE

Other trials in Argentina

Hungary3 sites

  • Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR

    Budapest, 1076

  • Semmelweis Egyetem AOK, Szemeszeti Klinika

    Budapest, 1083

  • Ganglion Medial Center

    Pécs, 7621

Other trials in Hungary

Mexico3 sites

  • Hospital Nuestra Señora de La Luz

    Mexico City, 06030

  • Hospital Universitario de Monterrey

    Monterrey, 64040

  • Instituto Mexicano de Oftalmologia I.A.P.

    Querétaro, 76090

Other trials in Mexico

Peru3 sites

  • Mácula D&T

    Lima, 27

  • TG Laser Oftalmica

    Lima, 27

  • Centro de Investigacion Oftalmolaser

    Lima, 33

Other trials in Peru

Russia3 sites

  • SAHI "Republic clinical ophthalmological hospial of Ministry of Heal of Tatarstan Republic"

    Kazan', 420012

  • FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences

    Moscow, 119435

  • St. Educ.Inst. of High Prof.Education "Samara State Medical University"; Chair of ophathalmology

    Samara, 443068

Other trials in Russia

Belgium2 sites

  • CHU Brugmann (Victor Horta)

    Brussels, 1020

  • UZ Leuven Sint Rafael

    Leuven, 3000

Other trials in Belgium

Netherlands2 sites

  • Radboud University Nijmegen Medical Centre; Ophthalmology

    Nijmegen, 6525 EX

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD

Other trials in Netherlands

Slovakia2 sites

  • FNsP F. D. Roosevelta Banska Bystrica, II.Ocna klinika SZU

    Banská Bystrica, 975 17

  • Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda Ocna klinika SZU a UNB

    Bratislava, 851 07

Other trials in Slovakia

Switzerland2 sites

  • Inselspital Bern, Universitätsklinik für Augenheilkunde

    Bern, 3010

  • Vista Klinik Binningen

    Binningen, 4102

Other trials in Switzerland

Austria1 site

  • Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

    Vienna, 1090

Other trials in Austria

Denmark1 site

  • Glostrup Hospital, Øjenafdelingen, Forskningsafsnit Ø37

    Glostrup Municipality, 2600

Other trials in Denmark

Sweden1 site

  • St Eriks Eye Hospital

    Stockholm, SE-112 82

Other trials in Sweden

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 Comparator
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

    10 mg dose of lampalizumab administered intravitreally.

  • Sham ComparatorOther

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

Study groups in NCT02247531
Study groupRoleWhat they receive
Lampalizumab once in every 4 weeks (Q4W)ExperimentalParticipants will receive 10 mg (milligrams) dose of lampalizumab by intravitreal injection, Q4W, starting at the Day 1 visit for approximately 92 weeks.
Receives: Drug: Lampalizumab
Lampalizumab once in every 6 weeks (Q6W)ExperimentalParticipants will receive 10 mg dose of lampalizumab by intravitreal injection, Q6W, starting at the Day 1 visit for approximately 90 weeks.
Receives: Drug: Lampalizumab
Sham ComparatorSham comparatorParticipants 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.
Receives: Other: Sham Comparator

What is being measured

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

  1. 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).

    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 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.

    Measured: Baseline, Week 48

  2. 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.

    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). 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.

    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). Data were 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 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.

    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. Data were 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. Data were 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 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.

    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 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.

    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 start6 Oct 2014
  3. Primary completion23 Jan 2018
  4. Study completion23 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
975 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02247531
Sponsor's protocol ID
GX29185
Other IDs
2014-000106-35, 2014
Acronym
SPECTRI
Status last verified
Oct 2019
First submitted
15 Jul 2014
Last updated
15 Oct 2019

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.

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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 153 sites in 22 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 2 inclusion and 7 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 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 153 sites in United States, United Kingdom, Germany, Spain, France and 17 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 14 Mar 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 Atropy (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 NCT02247531, which also lists 8 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 15 Oct 2019.

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