Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02247531
Other study ID # GX29185
Secondary ID 2014-000106-35
Status Terminated
Phase Phase 3
First received
Last updated
Start date October 6, 2014
Est. completion date January 23, 2018

Study information

Verified date October 2019
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


Recruitment information / eligibility

Status Terminated
Enrollment 975
Est. completion date January 23, 2018
Est. primary completion date January 23, 2018
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Lampalizumab
10 mg dose of lampalizumab administered intravitreally.
Other:
Sham Comparator
A sham injection is a procedure that mimics an intravitreal injection of lampalizumab.

Locations

Country Name City State
Argentina Instituto de la Vision Capital Federal
Argentina Oftalmos Capital Federal
Argentina Hospital El Cruce Florencio Varela
Australia Adelaide Eye and Retina Centre Adelaide South Australia
Australia Vision Eye Institute Eastern Box Hill Victoria
Australia Queensland Eye Institute Brisbane Queensland
Australia Royal Victorian Eye and Ear Hospital East Melbourne Victoria
Australia The Lions Eye Institute Nedlands Western Australia
Austria Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie Wien
Belgium CHU Brugmann (Victor Horta) Bruxelles
Belgium UZ Leuven Sint Rafael Leuven
Denmark Glostrup Hospital, Øjenafdelingen, Forskningsafsnit Ø37 Glostrup
France Hopital Pellegrin; Ophtalmologie Bordeaux
France CHU Bocage; Ophtalmologie Dijon
France Hopital de la croix rousse; Ophtalmologie Lyon cedex
France Centre Paradis Monticelli; Ophtalmologie Marseille
France Hopital Hotel Dieu Et Hme; Clinique Ophtalmologique Nantes
France CHNO des Quinze Vingts; Ophtalmologie Paris
Germany Universitätsklinikum Freiburg, Klinik für Augenheilkunde Freiburg
Germany Universitätsklinik Heidelberg; Augenklinik Heidelberg
Germany Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik Ludwigshafen
Germany Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik Mainz
Germany Klinikum rechts der Isar der TU München; Augenklinik München
Germany LMU Klinikum der Universität, Augenklinik München
Germany Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde Regensburg
Germany Universitätsklinikum Tübingen Tuebingen
Hungary Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR Budapest
Hungary Semmelweis Egyetem AOK, Szemeszeti Klinika Budapest
Hungary Ganglion Medial Center Pécs
Italy Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica Firenze Toscana
Italy UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA Genova Liguria
Italy ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco) Milano Lombardia
Italy Irccs Ospedale San Raffaele;U.O. Oculistica Milano Lombardia
Italy A.S.L. to1 Presidio Ospedaliero Sperino Oftalmico Torino Piemonte
Italy A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica Udine Veneto
Mexico Hospital Nuestra Señora de La Luz Mexico City
Mexico Hospital Universitario de Monterrey Monterrey
Mexico Instituto Mexicano de Oftalmologia I.A.P. Querétaro
Netherlands Radboud University Nijmegen Medical Centre; Ophthalmology Nijmegen
Netherlands Erasmus Medisch Centrum Rotterdam
Peru Centro de Investigacion Oftalmolaser Lima
Peru Mácula D&T Lima
Peru TG Laser Oftalmica Lima
Poland OFTALMIKA Sp. z o.o Bydgoszcz
Poland Szpital Specjalistyczny nr 1; Oddzial Okulistyki Bytom
Poland Klinika Okulistyczna Jasne Blonia Lódz
Poland Uniwersytecki Szpital Kliniczny; Klinika Okulistyki Wroclaw
Portugal AIBILI - Association for Innovation and Biomedical Research on Light Coimbra
Portugal Espaco Medico Coimbra Coimbra
Portugal Hospital de Santa Maria; Servico de Oftalmologia Lisboa
Portugal Hospital de Sao Joao; Servico de Oftalmologia Porto
Russian Federation SAHI "Republic clinical ophthalmological hospial of Ministry of Heal of Tatarstan Republic" Kazan
Russian Federation FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences Moscow
Russian Federation St. Educ.Inst. of High Prof.Education "Samara State Medical University"; Chair of ophathalmology Samara
Slovakia FNsP F. D. Roosevelta Banska Bystrica, II.Ocna klinika SZU Banska Bystrica
Slovakia Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda Ocna klinika SZU a UNB Bratislava
Spain Hospital Perpetuo Socorro; Servicio de Oftalmología Albacete
Spain Instituto de microcirugia ocular Barcelona
Spain Hospital Universitario Clínico San Carlos; Servicio de Oftalmologia Madrid
Spain VISSUM Madrid Santa Hortensia Madrid
Spain Clinica Universitaria de Navarra; Servicio de Oftalmologia Pamplona Navarra
Spain Instituto Oftalmologico Gomez Ulla Santiago de Compostela LA Coruña
Spain Hospital Universitario la Fe: Servicio de Oftalmologia Valencia
Sweden St Eriks Eye Hospital Stockholm
Switzerland Inselspital Bern, Universitätsklinik für Augenheilkunde Bern
Switzerland Vista Klinik Binningen Binningen
Turkey Ankara Baskent University Medical Faculty; Department of Ophthalmology Ankara
Turkey Ankara University Medical Faculty; Department of Ophthalmology Ankara
Turkey Hacettepe University Medical Faculty; Department of Ophthalmology Ankara
Turkey Istanbul University Istanbul Medical Faculty; Department of Ophthalmology Istanbul
Turkey Dokuz Eylul University Medical Faculty; Department of Ophthalmology Izmir
Turkey Ege University Medical Faculty; Department of Ophthalmology Izmir
United Kingdom Royal Victoria Hospital Belfast
United Kingdom Bradford Royal Infirmary Bradford
United Kingdom Bristol Eye Hospital Bristol
United Kingdom University Hospital of Wales Cardiff
United Kingdom Gloucestershire Hospitals NHS Foundation Trust Gloucestershire
United Kingdom Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre Liverpool
United Kingdom Kings College Hospital London
United Kingdom Moorfields Eye Hospital NHS Foundation Trust London
United Kingdom Macular Treatment Centre; Royal Eye Hospital Manchester
United Kingdom Hillingdon Hospital Middx
United Kingdom Royal Victoria Infirmary Newcastle upon Tyne
United Kingdom Southampton General Hospital Southampton
United Kingdom The Royal Wolverhampton Hospitals NHS Trust Wolverhampton
United Kingdom The York Hospital York
United States Retina Res Institute of Texas Abilene Texas
United States University of Michigan, Kellogg Eye Center Ann Arbor Michigan
United States Western Carolina Retinal Associate PA Asheville North Carolina
United States Retina & Vitreous Center of Southern Oregon Ashland Oregon
United States Emory University Atlanta Georgia
United States University of Colorado Aurora Colorado
United States The Retina Care Center Baltimore Maryland
United States Wilmer Eye Institute Baltimore Maryland
United States Vitreoretinal Associates of Washington Bellevue Washington
United States Mass Eye and Ear Infirmary Boston Massachusetts
United States MUSC Storm eye institute Charleston South Carolina
United States Char Eye Ear &Throat Assoc Charlotte North Carolina
United States Univ of Virginia Ophthalmology Charlottesville Virginia
United States Southeastern Retina Associates Chattanooga Chattanooga Tennessee
United States Mid Atlantic Retina - Wills Eye Hospital Cherry Hill New Jersey
United States Midwest Vision Research Foundation Chesterfield Missouri
United States Retina Group of Washington Chevy Chase Maryland
United States Cincinnati Eye Institute Cincinnati Ohio
United States Retina Consultants of Southern Colorado Springs Colorado
United States OSU Eye Physicians & Surgeons Columbus Ohio
United States Texas Retina Associates Dallas Texas
United States Kresge Eye Institute Detroit Michigan
United States Duke University Eye Center; Vitreoretinal Durham North Carolina
United States Vitreoretinal Surgery Edina Minnesota
United States Palmetto Retina Center Florence South Carolina
United States Retina Group of Florida Fort Lauderdale Florida
United States Retina Health Center Fort Myers Florida
United States Retina Consultants of Orange County Fullerton California
United States Charles Retina Institution Germantown Tennessee
United States Colorado Retina Associates, PC Golden Colorado
United States New England Retina Associates Hamden Connecticut
United States Retina Consultants of Houston Houston Texas
United States UCSD Shiley Eye Center La Jolla California
United States Charleston Neuroscience Inst Ladson South Carolina
United States Jules Stein Eye Institute/ UCLA Los Angeles California
United States N CA Retina Vitreous Assoc Mountain View California
United States Bascom Palmer Eye Institute Naples Florida
United States New York Weil Cornell Med Ctr New York New York
United States Vitreous-Retina-Macula New York New York
United States Retinal & Ophthalmic Cons PC Northfield New Jersey
United States UNMC Truhlsen Eye Institute Omaha Nebraska
United States Paducah Retinal Center Paducah Kentucky
United States Byers Eye Insitute at Stanford Palo Alto California
United States Mid Atlantic Retina Philadelphia Pennsylvania
United States Associated Retina Consultants Phoenix Arizona
United States Allegheny Ophthalmic & Orbital Pittsburgh Pennsylvania
United States Oregon HSU; Casey Eye Institute Portland Oregon
United States Retina Northwest Portland Oregon
United States Retina Consultants, San Diego Poway California
United States Black Hills Eye Institute Rapid City South Dakota
United States Sierra Eye Associates Reno Nevada
United States Retina Assoc of Western NY Rochester New York
United States Retinal Consultants Med Group Sacramento California
United States University of California, Davis, Eye Center Sacramento California
United States Retina Vitreous Assoc of FL Saint Petersburg Florida
United States California Retina Consultants Santa Barbara California
United States Southern Vitreoretinal Assoc Tallahassee Florida
United States University of South Florida Tampa Florida
United States Retina Associates of NJ Teaneck New Jersey
United States Scott and White Hospital Temple Texas
United States Retina Consultants of Houston The Woodlands Texas
United States Retina Specialists Towson Maryland
United States Retina Associates Southwest PC Tucson Arizona
United States Bay Area Retina Associates Walnut Creek California
United States Retina Group of New England Waterford Connecticut
United States Wolfe Eye Clinic West Des Moines Iowa
United States Vitreo Retinal Consultants Wichita Kansas

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Denmark,  France,  Germany,  Hungary,  Italy,  Mexico,  Netherlands,  Peru,  Poland,  Portugal,  Russian Federation,  Slovakia,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Recruiting NCT06161584 - A Prospective, Multicenter, Open-Label, Observational Phase 4 Study to Evaluate Real-World Safety, Tolerability, and Treatment Patterns of Pegcetacoplan (Syfovre) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Active, not recruiting NCT05536297 - Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy Phase 3
Completed NCT02515942 - CLG561 Proof-of-Concept Study as a Monotherapy and in Combination With LFG316 in Subjects With Geographic Atrophy (GA) Phase 2
Completed NCT02503332 - Study of Pegcetacoplan (APL-2) Therapy in Patients With Geographic Atrophy Phase 2
Recruiting NCT04339764 - Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration Phase 1/Phase 2
Completed NCT03295877 - Safety and Tolerability Study of RO7171009 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) Phase 1
Completed NCT01445548 - Sirolimus for Advanced Age-Related Macular Degeneration Phase 1/Phase 2
Completed NCT00973011 - A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of FCFD4514S in Patients With Geographic Atrophy Phase 1
Terminated NCT02247479 - A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration Phase 3
Completed NCT06006585 - A Study to Test How Well Different Doses of BI 771716 Are Tolerated by People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy Phase 1
Recruiting NCT05961332 - COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Geographic Atrophy N/A
Completed NCT02332343 - Sparing of the Fovea in Geographic Atrophy Progression N/A
Completed NCT01002950 - Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACU-4429 in Subjects With Geographic Atrophy Phase 2
Completed NCT03777332 - Study to Evaluate the Safety of Intravitreal APL-2 in Patients Diagnosed With Geographic Atrophy Phase 1
Active, not recruiting NCT04676854 - Restoration of Central Vision With the PRIMA System in Patients With Atrophic AMD N/A
Recruiting NCT02372916 - Geographic Atrophy and Intravitreal Ranibizumab Injections N/A
Active, not recruiting NCT05380492 - Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration Phase 1/Phase 2
Terminated NCT04607148 - A Study Assessing the Long-Term Safety and Tolerability of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration Phase 2
Terminated NCT02087085 - A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration Phase 2
Active, not recruiting NCT03845582 - Phase 3 Study of ALK-001 in Geographic Atrophy Phase 3