A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
- Registration Number
- NCT02247531
- Lead Sponsor
- Hoffmann-La Roche
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 975
- 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
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 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. Lampalizumab once in every 4 weeks (Q4W) Lampalizumab Participants will receive 10 mg (milligrams) dose of lampalizumab by intravitreal injection, Q4W, starting at the Day 1 visit for approximately 92 weeks. Lampalizumab once in every 6 weeks (Q6W) Lampalizumab Participants will receive 10 mg dose of lampalizumab by intravitreal injection, Q6W, starting at the Day 1 visit for approximately 90 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in Geographic Atropy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48 Baseline, 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).
Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48 Baseline, 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).
- Secondary Outcome Measures
Name Time Method Change From Baseline in Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48 Baseline, 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.
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score at Week 48 Baseline, 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.
Change From Baseline in NEI VFQ-25 Distance Activity Subscale Score at Week 48 Baseline, 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.
Change From Baseline in Number of Absolute Scotomatous Points Assessed by Mesopic Microperimetry at Week 48 Baseline, 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.
Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week 48 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.
Percentage of Participants With Less Than 15 Letters Loss From Baseline in LLVA Score at Week 48 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.
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 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.
Change From Baseline in Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions at Week 48 Baseline, 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.
Change From Baseline in Mean Functional Reading Independence (FRI) Index at Week 48 Baseline, 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.
Change From Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Charts or Radner Reading Charts at Week 48 Baseline, 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.
Change From Baseline in Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts at Week 48 Baseline, 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.
Change From Baseline in NEI VFQ-25 Near Activity Subscale Score at Week 48 Baseline, 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.
Trial Locations
- Locations (152)
Southern Vitreoretinal Assoc
🇺🇸Tallahassee, Florida, United States
Retina Health Center
🇺🇸Fort Myers, Florida, United States
Retina Consultants of Orange County
🇺🇸Fullerton, California, United States
UCSD Shiley Eye Center
🇺🇸La Jolla, California, United States
Byers Eye Insitute at Stanford
🇺🇸Palo Alto, California, United States
Jules Stein Eye Institute/ UCLA
🇺🇸Los Angeles, California, United States
N CA Retina Vitreous Assoc
🇺🇸Mountain View, California, United States
Retina Consultants, San Diego
🇺🇸Poway, California, United States
Bay Area Retina Associates
🇺🇸Walnut Creek, California, United States
California Retina Consultants
🇺🇸Santa Barbara, California, United States
Colorado Retina Associates, PC
🇺🇸Golden, Colorado, United States
Retina Consultants of Southern
🇺🇸Colorado Springs, Colorado, United States
Retina Group of Florida
🇺🇸Fort Lauderdale, Florida, United States
Retina Vitreous Assoc of FL
🇺🇸Saint Petersburg, Florida, United States
Retina Group of New England
🇺🇸Waterford, Connecticut, United States
Bascom Palmer Eye Institute
🇺🇸Naples, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Wolfe Eye Clinic
🇺🇸West Des Moines, Iowa, United States
Paducah Retinal Center
🇺🇸Paducah, Kentucky, United States
Wilmer Eye Institute
🇺🇸Baltimore, Maryland, United States
The Retina Care Center
🇺🇸Baltimore, Maryland, United States
Retina Group of Washington
🇺🇸Chevy Chase, Maryland, United States
Mass Eye and Ear Infirmary
🇺🇸Boston, Massachusetts, United States
Retina Specialists
🇺🇸Towson, Maryland, United States
Vitreoretinal Surgery
🇺🇸Edina, Minnesota, United States
Midwest Vision Research Foundation
🇺🇸Chesterfield, Missouri, United States
Retinal & Ophthalmic Cons PC
🇺🇸Northfield, New Jersey, United States
Vitreous-Retina-Macula
🇺🇸New York, New York, United States
New York Weil Cornell Med Ctr
🇺🇸New York, New York, United States
Western Carolina Retinal Associate PA
🇺🇸Asheville, North Carolina, United States
Retina Assoc of Western NY
🇺🇸Rochester, New York, United States
Cincinnati Eye Institute
🇺🇸Cincinnati, Ohio, United States
Retina & Vitreous Center of Southern Oregon
🇺🇸Ashland, Oregon, United States
OSU Eye Physicians & Surgeons
🇺🇸Columbus, Ohio, United States
Mid Atlantic Retina
🇺🇸Philadelphia, Pennsylvania, United States
Allegheny Ophthalmic & Orbital
🇺🇸Pittsburgh, Pennsylvania, United States
Southeastern Retina Associates Chattanooga
🇺🇸Chattanooga, Tennessee, United States
Charles Retina Institution
🇺🇸Germantown, Tennessee, United States
Retina Res Institute of Texas
🇺🇸Abilene, Texas, United States
Texas Retina Associates
🇺🇸Dallas, Texas, United States
Retina Consultants of Houston
🇺🇸The Woodlands, Texas, United States
Scott and White Hospital
🇺🇸Temple, Texas, United States
Univ of Virginia Ophthalmology
🇺🇸Charlottesville, Virginia, United States
Vitreoretinal Associates of Washington
🇺🇸Bellevue, Washington, United States
Instituto de la Vision
🇦🇷Capital Federal, Argentina
Queensland Eye Institute
🇦🇺Brisbane, Queensland, Australia
Adelaide Eye and Retina Centre
🇦🇺Adelaide, South Australia, Australia
Royal Victorian Eye and Ear Hospital
🇦🇺East Melbourne, Victoria, Australia
CHU Brugmann (Victor Horta)
🇧🇪Bruxelles, Belgium
Hopital de la croix rousse; Ophtalmologie
🇫🇷Lyon cedex, France
Hopital Pellegrin; Ophtalmologie
🇫🇷Bordeaux, France
CHU Bocage; Ophtalmologie
🇫🇷Dijon, France
Centre Paradis Monticelli; Ophtalmologie
🇫🇷Marseille, France
Hopital Hotel Dieu Et Hme; Clinique Ophtalmologique
🇫🇷Nantes, France
Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik
🇩🇪Ludwigshafen, Germany
CHNO des Quinze Vingts; Ophtalmologie
🇫🇷Paris, France
Universitätsklinik Heidelberg; Augenklinik
🇩🇪Heidelberg, Germany
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
🇩🇪Freiburg, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik
🇩🇪Mainz, Germany
Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR
🇭🇺Budapest, Hungary
Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde
🇩🇪Regensburg, Germany
Klinikum rechts der Isar der TU München; Augenklinik
🇩🇪München, Germany
LMU Klinikum der Universität, Augenklinik
🇩🇪München, Germany
Universitätsklinikum Tübingen
🇩🇪Tuebingen, Germany
Semmelweis Egyetem AOK, Szemeszeti Klinika
🇭🇺Budapest, Hungary
Ganglion Medial Center
🇭🇺Pécs, Hungary
Irccs Ospedale San Raffaele;U.O. Oculistica
🇮🇹Milano, Lombardia, Italy
A.S.L. to1 Presidio Ospedaliero Sperino Oftalmico
🇮🇹Torino, Piemonte, Italy
Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica
🇮🇹Firenze, Toscana, Italy
ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)
🇮🇹Milano, Lombardia, Italy
Hospital Nuestra Señora de La Luz
🇲🇽Mexico City, Mexico
A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica
🇮🇹Udine, Veneto, Italy
Erasmus Medisch Centrum
🇳🇱Rotterdam, Netherlands
Mácula D&T
🇵🇪Lima, Peru
Szpital Specjalistyczny nr 1; Oddzial Okulistyki
🇵🇱Bytom, Poland
TG Laser Oftalmica
🇵🇪Lima, Peru
OFTALMIKA Sp. z o.o
🇵🇱Bydgoszcz, Poland
Centro de Investigacion Oftalmolaser
🇵🇪Lima, Peru
Uniwersytecki Szpital Kliniczny; Klinika Okulistyki
🇵🇱Wrocław, Poland
Klinika Okulistyczna Jasne Błonia
🇵🇱Łódź, Poland
Espaco Medico Coimbra
🇵🇹Coimbra, Portugal
AIBILI - Association for Innovation and Biomedical Research on Light
🇵🇹Coimbra, Portugal
Hospital de Santa Maria; Servico de Oftalmologia
🇵🇹Lisboa, Portugal
SAHI "Republic clinical ophthalmological hospial of Ministry of Heal of Tatarstan Republic"
🇷🇺Kazan, Russian Federation
St. Educ.Inst. of High Prof.Education "Samara State Medical University"; Chair of ophathalmology
🇷🇺Samara, Russian Federation
FNsP F. D. Roosevelta Banska Bystrica, II.Ocna klinika SZU
🇸🇰Banska Bystrica, Slovakia
Hospital Perpetuo Socorro; Servicio de Oftalmología
🇪🇸Albacete, Spain
Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda Ocna klinika SZU a UNB
🇸🇰Bratislava, Slovakia
Instituto Oftalmologico Gomez Ulla
🇪🇸Santiago de Compostela, LA Coruña, Spain
Clinica Universitaria de Navarra; Servicio de Oftalmologia
🇪🇸Pamplona, Navarra, Spain
VISSUM Madrid Santa Hortensia
🇪🇸Madrid, Spain
Instituto de microcirugia ocular
🇪🇸Barcelona, Spain
Hospital Universitario Clínico San Carlos; Servicio de Oftalmologia
🇪🇸Madrid, Spain
Hospital Universitario la Fe: Servicio de Oftalmologia
🇪🇸Valencia, Spain
St Eriks Eye Hospital
🇸🇪Stockholm, Sweden
Vista Klinik Binningen
🇨🇭Binningen, Switzerland
Inselspital Bern, Universitätsklinik für Augenheilkunde
🇨🇭Bern, Switzerland
Ankara Baskent University Medical Faculty; Department of Ophthalmology
🇹🇷Ankara, Turkey
Ege University Medical Faculty; Department of Ophthalmology
🇹🇷Izmir, Turkey
Dokuz Eylul University Medical Faculty; Department of Ophthalmology
🇹🇷Izmir, Turkey
Istanbul University Istanbul Medical Faculty; Department of Ophthalmology
🇹🇷Istanbul, Turkey
Bradford Royal Infirmary
🇬🇧Bradford, United Kingdom
Bristol Eye Hospital
🇬🇧Bristol, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, United Kingdom
Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre
🇬🇧Liverpool, United Kingdom
Gloucestershire Hospitals NHS Foundation Trust
🇬🇧Gloucestershire, United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
Kings College Hospital
🇬🇧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
The York Hospital
🇬🇧York, United Kingdom
The Royal Wolverhampton Hospitals NHS Trust
🇬🇧Wolverhampton, United Kingdom
The Lions Eye Institute
🇦🇺Nedlands, Western Australia, Australia
Vitreo Retinal Consultants
🇺🇸Wichita, Kansas, United States
Kresge Eye Institute
🇺🇸Detroit, Michigan, United States
Duke University Eye Center; Vitreoretinal
🇺🇸Durham, North Carolina, United States
Glostrup Hospital, Øjenafdelingen, Forskningsafsnit Ø37
🇩🇰Glostrup, Denmark
Retina Northwest
🇺🇸Portland, Oregon, United States
Oregon HSU; Casey Eye Institute
🇺🇸Portland, Oregon, United States
Royal Victoria Hospital
🇬🇧Belfast, United Kingdom
Southampton General Hospital
🇬🇧Southampton, United Kingdom
Hacettepe University Medical Faculty; Department of Ophthalmology
🇹🇷Ankara, Turkey
Ankara University Medical Faculty; Department of Ophthalmology
🇹🇷Ankara, Turkey
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
Retina Associates of NJ
🇺🇸Teaneck, New Jersey, United States
Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie
🇦🇹Wien, Austria
Mid Atlantic Retina - Wills Eye Hospital
🇺🇸Cherry Hill, New Jersey, United States
Hospital El Cruce
🇦🇷Florencio Varela, Argentina
Hospital de Sao Joao; Servico de Oftalmologia
🇵🇹Porto, Portugal
Associated Retina Consultants
🇺🇸Phoenix, Arizona, United States
Palmetto Retina Center
🇺🇸Florence, South Carolina, United States
UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA
🇮🇹Genova, Liguria, Italy
Radboud University Nijmegen Medical Centre; Ophthalmology
🇳🇱Nijmegen, Netherlands
Retina Associates Southwest PC
🇺🇸Tucson, Arizona, United States
New England Retina Associates
🇺🇸Hamden, Connecticut, United States
Black Hills Eye Institute
🇺🇸Rapid City, South Dakota, United States
UZ Leuven Sint Rafael
🇧🇪Leuven, Belgium
Instituto Mexicano de Oftalmologia I.A.P.
🇲🇽Querétaro, Mexico
FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences
🇷🇺Moscow, Russian Federation
Oftalmos
🇦🇷Capital Federal, Argentina
Hospital Universitario de Monterrey
🇲🇽Monterrey, Mexico
Charleston Neuroscience Inst
🇺🇸Ladson, South Carolina, United States
Vision Eye Institute Eastern
🇦🇺Box Hill, Victoria, Australia
University of California, Davis, Eye Center
🇺🇸Sacramento, California, United States
Retinal Consultants Med Group
🇺🇸Sacramento, California, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
University of South Florida
🇺🇸Tampa, Florida, United States
University of Michigan, Kellogg Eye Center
🇺🇸Ann Arbor, Michigan, United States
MUSC Storm eye institute
🇺🇸Charleston, South Carolina, United States
UNMC Truhlsen Eye Institute
🇺🇸Omaha, Nebraska, United States
Char Eye Ear &Throat Assoc
🇺🇸Charlotte, North Carolina, United States