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

NCT02247531 | Terminated Phase 3 Results

• 2 other identifiers: GX291852014-000106-35
• Study Type: interventional
• Target: 975
• Locations: 21 countries
• Sites: 148

Brief Summary

This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Conditions

Geographic Atrophy

Outcome Measures

Primary Outcomes (2)

• 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

• Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48

  For CFI profile, positive or negative biomarker status refers to the presence (carrier) or absence of the risk allele at CFI and at least one risk allele at complement factor H (CFH) or risk locus containing both complement component 2 and complement factor B (C2/CFB).The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).

  Baseline, Week 48

Secondary Outcomes (12)

• Change From Baseline in Number of Absolute Scotomatous Points Assessed by Mesopic Microperimetry at Week 48

  Baseline, Week 48

• Change From Baseline in Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48

  Baseline, Week 48

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

  Baseline, Week 48

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

  Week 48

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

  Baseline, Week 48

Study Arms (3)

Lampalizumab once in every 4 weeks (Q4W)

EXPERIMENTAL

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

Lampalizumab once in every 6 weeks (Q6W)

EXPERIMENTAL

Participants will receive 10 mg dose of lampalizumab by intravitreal injection, Q6W, starting at the Day 1 visit for approximately 90 weeks.

Drug: Lampalizumab

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

Interventions

Lampalizumab DRUG

10 mg dose of lampalizumab administered intravitreally.

Also known as: RO5490249

Lampalizumab once in every 4 weeks (Q4W); Lampalizumab once in every 6 weeks (Q6W)

Sham Comparator OTHER

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

Sham Comparator

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
• Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy
• Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation)
• GA in either eye due to causes other than AMD
• Previous treatment with eculizumab, lampalizumab, and/or fenretinide

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (153)

Associated Retina Consultants

Phoenix, Arizona, 85020, United States

Location

Retina Associates Southwest PC

Tucson, Arizona, 85750, United States

Location

Retina Consultants of Orange County

Fullerton, California, 92835, United States

Location

UCSD Shiley Eye Center

La Jolla, California, 92093-0946, United States

Location

Jules Stein Eye Institute/ UCLA

Los Angeles, California, 90095-7000, United States

Location

N CA Retina Vitreous Assoc

Mountain View, California, 94040, United States

Location

Byers Eye Insitute at Stanford

Palo Alto, California, 94303, United States

Location

Retina Consultants, San Diego

Poway, California, 92064, United States

Location

University of California, Davis, Eye Center

Sacramento, California, 95817, United States

Location

Retinal Consultants Med Group

Sacramento, California, 95841, United States

Location

California Retina Consultants

Santa Barbara, California, 93103, United States

Location

Bay Area Retina Associates

Walnut Creek, California, 94598, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Retina Consultants of Southern

Colorado Springs, Colorado, 80909, United States

Location

Colorado Retina Associates, PC

Golden, Colorado, 80401, United States

Location

New England Retina Associates

Hamden, Connecticut, 06518, United States

Location

Retina Group of New England

Waterford, Connecticut, 06385, United States

Location

Retina Group of Florida

Fort Lauderdale, Florida, 33308, United States

Location

Retina Health Center

Fort Myers, Florida, 33907, United States

Location

Bascom Palmer Eye Institute

Naples, Florida, 34103, United States

Location

Retina Vitreous Assoc of FL

St. Petersburg, Florida, 33711, United States

Location

Southern Vitreoretinal Assoc

Tallahassee, Florida, 32308, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Wolfe Eye Clinic

West Des Moines, Iowa, 50266, United States

Location

Vitreo Retinal Consultants

Wichita, Kansas, 67214, United States

Location

Paducah Retinal Center

Paducah, Kentucky, 42001, United States

Location

The Retina Care Center

Baltimore, Maryland, 21209, United States

Location

Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Location

Retina Group of Washington

Chevy Chase, Maryland, 20815, United States

Location

Retina Specialists

Towson, Maryland, 21204, United States

Location

Mass Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

University of Michigan, Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

Location

Kresge Eye Institute

Detroit, Michigan, 48201-1423, United States

Location

Vitreoretinal Surgery

Edina, Minnesota, 55435, United States

Location

Midwest Vision Research Foundation

Chesterfield, Missouri, 63017, United States

Location

UNMC Truhlsen Eye Institute

Omaha, Nebraska, 68105, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

Mid Atlantic Retina - Wills Eye Hospital

Cherry Hill, New Jersey, 08034, United States

Location

Retinal & Ophthalmic Cons PC

Northfield, New Jersey, 08225, United States

Location

Retina Associates of NJ

Teaneck, New Jersey, 07666, United States

Location

New York Weil Cornell Med Ctr

New York, New York, 10021, United States

Location

Vitreous-Retina-Macula

New York, New York, 10022, United States

Location

Retina Assoc of Western NY

Rochester, New York, 14620, United States

Location

Western Carolina Retinal Associate PA

Asheville, North Carolina, 28803, United States

Location

Char Eye Ear &Throat Assoc

Charlotte, North Carolina, 28210, United States

Location

Duke University Eye Center; Vitreoretinal

Durham, North Carolina, 27710, United States

Location

Cincinnati Eye Institute

Cincinnati, Ohio, 45242, United States

Location

OSU Eye Physicians & Surgeons

Columbus, Ohio, 43212, United States

Location

Retina & Vitreous Center of Southern Oregon

Ashland, Oregon, 97520, United States

Location

Retina Northwest

Portland, Oregon, 97221, United States

Location

Oregon HSU; Casey Eye Institute

Portland, Oregon, 97239, United States

Location

Mid Atlantic Retina

Philadelphia, Pennsylvania, 19107, United States

Location

Allegheny Ophthalmic & Orbital

Pittsburgh, Pennsylvania, 15212, United States

Location

MUSC Storm eye institute

Charleston, South Carolina, United States

Location

Palmetto Retina Center

Florence, South Carolina, 29501, United States

Location

Charleston Neuroscience Inst

Ladson, South Carolina, 29456, United States

Location

Black Hills Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Southeastern Retina Associates Chattanooga

Chattanooga, Tennessee, 37421, United States

Location

Charles Retina Institution

Germantown, Tennessee, 38138, United States

Location

Retina Res Institute of Texas

Abilene, Texas, 79606, United States

Location

Texas Retina Associates

Dallas, Texas, 75231, United States

Location

Retina Consultants of Houston

Houston, Texas, 77030, United States

Location

Scott and White Hospital

Temple, Texas, 76504, United States

Location

Retina Consultants of Houston

The Woodlands, Texas, 77384, United States

Location

Univ of Virginia Ophthalmology

Charlottesville, Virginia, 22903, United States

Location

Vitreoretinal Associates of Washington

Bellevue, Washington, 98004, United States

Location

Oftalmos

Capital Federal, C1120AAN, Argentina

Location

Instituto de la Vision

Capital Federal, C1122AAI, Argentina

Location

Hospital El Cruce

San Juan Bautista, B1888AAE, Argentina

Location

Queensland Eye Institute

Brisbane, Queensland, 4101, Australia

Location

Adelaide Eye and Retina Centre

Adelaide, South Australia, 5000, Australia

Location

Vision Eye Institute Eastern

Box Hill, Victoria, 3128, Australia

Location

Royal Victorian Eye and Ear Hospital

East Melbourne, Victoria, 3002, Australia

Location

The Lions Eye Institute

Nedlands, Western Australia, 6009, Australia

Location

Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

Vienna, 1090, Austria

Location

CHU Brugmann (Victor Horta)

Brussels, 1020, Belgium

Location

UZ Leuven Sint Rafael

Leuven, 3000, Belgium

Location

Glostrup Hospital, Øjenafdelingen, Forskningsafsnit Ø37

Glostrup Municipality, 2600, Denmark

Location

Hopital Pellegrin; Ophtalmologie

Bordeaux, 33000, France

Location

CHU Bocage; Ophtalmologie

Dijon, 21079, France

Location

Hopital de la croix rousse; Ophtalmologie

Lyon, 69317, France

Location

Centre Paradis Monticelli; Ophtalmologie

Marseille, 13008, France

Location

Hopital Hotel Dieu Et Hme; Clinique Ophtalmologique

Nantes, 44093, France

Location

CHNO des Quinze Vingts; Ophtalmologie

Paris, 75012, France

Location

Universitätsklinikum Freiburg, Klinik für Augenheilkunde

Freiburg im Breisgau, 79106, Germany

Location

Universitätsklinik Heidelberg; Augenklinik

Heidelberg, 69120, Germany

Location

Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik

Ludwigshafen, 67063, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik

Mainz, 55131, Germany

Location

LMU Klinikum der Universität, Augenklinik

München, 80336, Germany

Location

Klinikum rechts der Isar der TU München; Augenklinik

München, 81675, Germany

Location

Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde

Regensburg, 93053, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

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

Budapest, 1076, Hungary

Location

Semmelweis Egyetem AOK, Szemeszeti Klinika

Budapest, 1083, Hungary

Location

Ganglion Medial Center

Pécs, 7621, Hungary

Location

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

Genoa, Liguria, 16132, Italy

Location

Irccs Ospedale San Raffaele;U.O. Oculistica

Milan, Lombardy, 20132, Italy

Location

ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

Milan, Lombardy, 20157, Italy

Location

A.S.L. to1 Presidio Ospedaliero Sperino Oftalmico

Turin, Piedmont, 10122, Italy

Location

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

Florence, Tuscany, 50134, Italy

Location

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

Udine, Veneto, 33100, Italy

Location

Hospital Nuestra Señora de La Luz

Mexico City, 06030, Mexico

Location

Hospital Universitario de Monterrey

Monterrey, 64040, Mexico

Location

Instituto Mexicano de Oftalmologia I.A.P.

Querétaro, 76090, Mexico

Location

Radboud University Nijmegen Medical Centre; Ophthalmology

Nijmegen, 6525 EX, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, 3015 GD, Netherlands

Location

Mácula D&T

Lima, 27, Peru

Location

TG Laser Oftalmica

Lima, 27, Peru

Location

Centro de Investigacion Oftalmolaser

Lima, 33, Peru

Location

OFTALMIKA Sp. z o.o

Bydgoszcz, 85-631, Poland

Location

Szpital Specjalistyczny nr 1; Oddzial Okulistyki

Bytom, 41-902, Poland

Location

Klinika Okulistyczna Jasne Błonia

Lodz, 91-134, Poland

Location

Uniwersytecki Szpital Kliniczny; Klinika Okulistyki

Wroclaw, 50-556, Poland

Location

AIBILI - Association for Innovation and Biomedical Research on Light

Coimbra, 3000-548, Portugal

Location

Espaco Medico Coimbra

Coimbra, 3030-163, Portugal

Location

Hospital de Santa Maria; Servico de Oftalmologia

Lisbon, 1649-035, Portugal

Location

Hospital de Sao Joao; Servico de Oftalmologia

Porto, 4200-319, Portugal

Location

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

Kazan', 420012, Russia

Location

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

Moscow, 119435, Russia

Location

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

Samara, 443068, Russia

Location

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

Banská Bystrica, 975 17, Slovakia

Location

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

Bratislava, 851 07, Slovakia

Location

Instituto Oftalmologico Gomez Ulla

Santiago de Compostela, LA Coruña, 15706, Spain

Location

Clinica Universitaria de Navarra; Servicio de Oftalmologia

Pamplona, Navarre, 31008, Spain

Location

Hospital Perpetuo Socorro; Servicio de Oftalmología

Albacete, 02006, Spain

Location

Instituto de microcirugia ocular

Barcelona, 08035, Spain

Location

VISSUM Madrid Santa Hortensia

Madrid, 28002, Spain

Location

Hospital Universitario Clínico San Carlos; Servicio de Oftalmologia

Madrid, 28040, Spain

Location

Hospital Universitario la Fe: Servicio de Oftalmologia

Valencia, 46026, Spain

Location

St Eriks Eye Hospital

Stockholm, SE-112 82, Sweden

Location

Inselspital Bern, Universitätsklinik für Augenheilkunde

Bern, 3010, Switzerland

Location

Vista Klinik Binningen

Binningen, 4102, Switzerland

Location

Hacettepe University Medical Faculty; Department of Ophthalmology

Ankara, 06100, Turkey (Türkiye)

Location

Ankara University Medical Faculty; Department of Ophthalmology

Ankara, 06340, Turkey (Türkiye)

Location

Ankara Baskent University Medical Faculty; Department of Ophthalmology

Ankara, 06490, Turkey (Türkiye)

Location

Istanbul University Istanbul Medical Faculty; Department of Ophthalmology

Istanbul, 34093, Turkey (Türkiye)

Location

Ege University Medical Faculty; Department of Ophthalmology

Izmir, 35100, Turkey (Türkiye)

Location

Dokuz Eylul University Medical Faculty; Department of Ophthalmology

Izmir, 35340, Turkey (Türkiye)

Location

Royal Victoria Hospital

Belfast, BT12 6BA, United Kingdom

Location

Bradford Royal Infirmary

Bradford, BD9 6RJ, United Kingdom

Location

Bristol Eye Hospital

Bristol, BS1 2LX, United Kingdom

Location

University Hospital of Wales

Cardiff, CF14 4XW, United Kingdom

Location

Gloucestershire Hospitals NHS Foundation Trust

Gloucestershire, GL1 3NN, United Kingdom

Location

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

Liverpool, L7 8XP, United Kingdom

Location

Moorfields Eye Hospital NHS Foundation Trust

London, EC1V 2PD, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

Macular Treatment Centre; Royal Eye Hospital

Manchester, M13 9WL, United Kingdom

Location

Hillingdon Hospital

Middx, UB8 3NN, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

The Royal Wolverhampton Hospitals NHS Trust

Wolverhampton, WV10 0QP, United Kingdom

Location

The York Hospital

York, YO31 8HE, United Kingdom

Location

Related Publications (7)

• Salvi A, Cluceru J, Gao SS, Rabe C, Schiffman C, Yang Q, Lee AY, Keane PA, Sadda SR, Holz FG, Ferrara D, Anegondi N. Deep Learning to Predict the Future Growth of Geographic Atrophy from Fundus Autofluorescence. Ophthalmol Sci. 2024 Oct 23;5(2):100635. doi: 10.1016/j.xops.2024.100635. eCollection 2025 Mar-Apr.

  PMID: 39758130 DERIVED

• 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.

  PMID: 39102242 DERIVED

• 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.

  PMID: 38900484 DERIVED

• 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.

  PMID: 37869030 DERIVED

• 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.

  PMID: 37314061 DERIVED

• 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.

  PMID: 32199866 DERIVED

• 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.

  PMID: 29801123 DERIVED

MeSH Terms

Conditions

Geographic Atrophy

Interventions

lampalizumab

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Limitations and Caveats

This study was terminated early by the Sponsor because the compound had demonstrated lack of efficacy. Thus, not all participants in this study completed the full duration of treatment.

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: September 25, 2014
• Study Start: October 6, 2014
• Primary Completion: January 23, 2018
• Study Completion: January 23, 2018
• Last Updated: October 15, 2019
• Results First Posted: March 14, 2019

Record last verified: 2019-10

Locations

SE (1); NL (2); CH (2); GB (14); ES (7); US (67); DE (8); PE (3); TU (6); BE (2); FR (6); IT (6); PT (4); RU (3); SL (2); AU (1); HU (3); ME (3); AR (3); PL (4); DK (1)