A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
- Registration Number
- NCT02247479
- 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
- 906
- 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 (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 Lampalizumab Once in Every 4 Weeks (Q4W) Lampalizumab Participants will receive 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections for approximately 96 weeks. Lampalizumab Once in Every 6 Weeks (Q6W) Lampalizumab Participants will receive 10 mg dose of lampalizumab administered by intravitreal injections for approximately 96 weeks. Sham Comparator Sham Participants will receive sham comparator Q4W or Q6W for 96 weeks.
- Primary Outcome Measures
Name Time Method 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).
Change From Baseline in Geographic Atrophy (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).
- Secondary Outcome Measures
Name Time Method 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). BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The data was 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 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 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 Number of Absolute Scotomatous Points as Assessed by Mesopic Micrometry 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, a maximum of 68 points were tested within this range. Higher results indicate expansion of absolute scotoma and higher number of abolute scotomatous points. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening.
Change From Baseline in Mean 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. The data was 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). BCVA score testing was performed prior to dilating the eyes. 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. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
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 LLVA 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. LLVA 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). The data was 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. 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. The data was 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, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the visual functioning; 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.
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 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.
Trial Locations
- Locations (144)
Texas Retina Associates
🇺🇸Arlington, Texas, United States
Orange County Retina Med Group
🇺🇸Santa Ana, California, United States
Maine Eye Center
🇺🇸Portland, Maine, United States
Assoc Retinal Consultants PC
🇺🇸Royal Oak, Michigan, United States
Retina Consultants of Western New York
🇺🇸Orchard Park, New York, United States
Retina Consultants of Michigan
🇺🇸Southfield, Michigan, United States
Western Carolina Retinal Associate PA
🇺🇸Asheville, North Carolina, United States
West Virginia University Eye Institute
🇺🇸Morgantown, West Virginia, United States
Retina Specialists
🇺🇸Towson, Maryland, United States
Cleveland Clinic Foundation; Cole Eye Institute
🇺🇸Cleveland, Ohio, United States
Tufts Medical Center Research
🇺🇸Boston, Massachusetts, United States
Ophthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
Retina Consultants of Nevada
🇺🇸Las Vegas, Nevada, United States
Retina Associates
🇺🇸Shawnee Mission, Kansas, United States
CHU Sart-Tilman
🇧🇪Liège, Belgium
Sjællands Universitetshospital, Roskilde; Øjenafdelingen
🇩🇰Roskilde, Denmark
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Optimum Profesorskie Centrum Okulistyki
🇵🇱Gdańsk, Poland
Gabinet Okulistyczny Prof Edward Wylegala
🇵🇱Katowice, Poland
Retinal Research Institute, LLC
🇺🇸Phoenix, Arizona, United States
W Coast Retina Med Group Inc
🇺🇸San Francisco, California, United States
UCSF; Ophthalmology
🇺🇸San Francisco, California, United States
Tennessee Retina PC.
🇺🇸Nashville, Tennessee, United States
Retina Associates of Utah
🇺🇸Salt Lake City, Utah, United States
Uni of Alabama At Birmingham Clinical Research Unit
🇺🇸Birmingham, Alabama, United States
Retina Centers P.C.
🇺🇸Tucson, Arizona, United States
California Retina Consultants
🇺🇸Santa Barbara, California, United States
The Gavin Herbert Eye Institute - UC, Irvine
🇺🇸Irvine, California, United States
Retina-Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
Jules Stein Eye Institute/ UCLA
🇺🇸Los Angeles, California, United States
Florida Eye Microsurgical Inst
🇺🇸Boynton Beach, Florida, United States
Retina Care Specialists
🇺🇸Palm Beach Gardens, Florida, United States
Florida Eye Associates
🇺🇸Melbourne, Florida, United States
Fort Lauderdale Eye Institute
🇺🇸Plantation, Florida, United States
Retina Specialty Institute
🇺🇸Pensacola, Florida, United States
Bascom Palmer Eye Institute
🇺🇸Palm Beach Gardens, Florida, United States
Retina Vitreous Assoc of FL
🇺🇸Saint Petersburg, Florida, United States
Southern Vitreoretinal Assoc
🇺🇸Tallahassee, Florida, United States
Retina Associates of Florida, LLC
🇺🇸Tampa, Florida, United States
Southeast Retina Center
🇺🇸Augusta, Georgia, United States
Georgia Retina PC
🇺🇸Marietta, Georgia, United States
University Retina and Macula Associates, PC
🇺🇸Oak Forest, Illinois, United States
Northwestern Medical Group/Northwestern University
🇺🇸Chicago, Illinois, United States
Retina Consultants of Hawaii
🇺🇸'Aiea, Hawaii, United States
Midwest Eye Institute Northside
🇺🇸Indianapolis, Indiana, United States
Wolfe Eye Clinic
🇺🇸West Des Moines, Iowa, United States
Retina Associates of Kentucky
🇺🇸Lexington, Kentucky, United States
Lahey Clinic Med Ctr
🇺🇸Lexington, Kentucky, United States
Vitreo-Retinal Associates, PC
🇺🇸Worcester, Massachusetts, United States
Specialty Eye Institute
🇺🇸Jackson, Michigan, United States
Vitreo-Retinal Associates
🇺🇸Grand Rapids, Michigan, United States
Retina Center of New Jersey
🇺🇸Bloomfield, New Jersey, United States
New Jersey Retina Research Foundation
🇺🇸Edison, New Jersey, United States
Delaware Valley Retina Assoc
🇺🇸Lawrenceville, New Jersey, United States
Long Is. Vitreoretinal Consult
🇺🇸Hauppauge, New York, United States
Opthalmic Consultants of LI
🇺🇸Lynbrook, New York, United States
New York Eye & Ear Infirmary
🇺🇸New York, New York, United States
Retina Vit Surgeons/Central NY
🇺🇸Syracuse, New York, United States
Retina Assoc of Cleveland Inc
🇺🇸Beachwood, Ohio, United States
Retina Vitreous Consultants
🇺🇸Monroeville, Pennsylvania, United States
Associates in Ophthalmology
🇺🇸West Mifflin, Pennsylvania, United States
Retina Res Institute of Texas
🇺🇸Abilene, Texas, United States
UT Southwestern MC at Dallas
🇺🇸Dallas, Texas, United States
Valley Retina Institute P.A.
🇺🇸McAllen, Texas, United States
Strategic Clinical Research Group, LLC
🇺🇸Willow Park, Texas, United States
Virginia Retina Center
🇺🇸Warrenton, Virginia, United States
Retina Center Northwest
🇺🇸Silverdale, Washington, United States
Spokane Eye Clinical Research
🇺🇸Spokane, Washington, United States
MicrocirugÃa Ocular S.A
🇦🇷Rosario, Argentina
Organizacion Medica de Investigacion
🇦🇷Buenos Aires, Argentina
Oftar
🇦🇷Mendoza, Argentina
Fundacion Zambrano
🇦🇷Caba, Argentina
Eyeclinic Albury Wodonga
🇦🇺Albury, New South Wales, Australia
Marsden Eye Research Centre
🇦🇺Parramatta, New South Wales, Australia
Save Sight Institute
🇦🇺Sydney, New South Wales, Australia
UZ Gent
🇧🇪Gent, Belgium
Sydney West Retina
🇦🇺Westmead, New South Wales, Australia
Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde
🇦🇹Linz, Austria
UZ Leuven Sint Rafael
🇧🇪Leuven, Belgium
QEII - HSC Department of Ophthalmology
🇨🇦Halifax, Nova Scotia, Canada
Calgary Retina Consultants
🇨🇦Calgary, Alberta, Canada
University of Ottawa Eye Institute
🇨🇦Ottawa, Ontario, Canada
University Health Network Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Institut De L'Oeil Des Laurentides
🇨🇦Boisbriand, Quebec, Canada
Centre Odeon; Exploration Ophtalmologique
🇫🇷Paris, France
Chi De Creteil; Ophtalmologie
🇫🇷Creteil, France
Hopital Lariboisiere; Ophtalmologie
🇫🇷Paris, France
Centre Ophtalmologique; Imagerie et laser
🇫🇷Paris, France
CHU Poitiers - CHR La Miletrie; Ophtalmologie
🇫🇷Poitiers, France
Universitäts-Augenklinik Bonn
🇩🇪Bonn, Germany
Ch Pitie Salpetriere; Ophtalmologie
🇫🇷Paris, France
Medizinische Hochschule Hannover, Klinik für Augenheilkunde
🇩🇪Hannover, Germany
Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde
🇩🇪Göttingen, Germany
Universitätskliniikum Schleswig-Holstein, Campus Lübeck, Klinik für Augenheilkunde
🇩🇪Lübeck, Germany
Universitätsklinikum Köln; Augenklinik
🇩🇪Köln, Germany
Augenabteilung am St. Franziskus-Hospital
🇩🇪Münster, Germany
Universitätsklinikum Münster; Augenheilkunde
🇩🇪Münster, Germany
Budapest Retina Associates Kft.
ðŸ‡ðŸ‡ºBudapest, Hungary
Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
ðŸ‡ðŸ‡ºDebrecem, Hungary
Ganglion Medial Center
ðŸ‡ðŸ‡ºPecs, Hungary
Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
🇮🇹Roma, Lazio, Italy
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica
🇮🇹Milano, Lombardia, Italy
Macula Retina Consultores
🇲🇽Mexico, D.F., Mexico
Academisch Medisch Centrum Universiteit Amsterdam
🇳🇱Amsterdam, Netherlands
Azienda Ospedaliero Universitaria Di Sassari;U.O. Oculistica
🇮🇹Sassari, Sardegna, Italy
Hospital de la Ceguera APEC
🇲🇽Mexico, D.F., Mexico
Radboud University Nijmegen Medical Centre; Ophthalmology
🇳🇱Nijmegen, Netherlands
Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie
🇸🇰Zilina, Slovakia
Hospital Universitari de Bellvitge; Servicio de Oftalmologia
🇪🇸Hospitalet De Llobregat, Barcelona, Spain
Hospital General de Catalunya
🇪🇸San Cugat Del Valles, Barcelona, Spain
Institut de la Macula i la retina
🇪🇸Barcelona, Spain
Ayr Hospital
🇬🇧AYR, United Kingdom
Stadtspital Triemli; Augenklinik
🇨ðŸ‡Zürich, Switzerland
Hospital Universitario Rio Hortega; Servicio de Oftalmologia
🇪🇸Valladolid, Spain
The Princess Alexandra Eye Pavilion
🇬🇧Edinburgh, United Kingdom
Frimley Park Hospital
🇬🇧Frimley, United Kingdom
Royal Hallamshire Hospita
🇬🇧Sheffield, United Kingdom
Eye Surgical Associates
🇺🇸Lincoln, Nebraska, United States
National Ophthalmic Research Institute
🇺🇸Fort Myers, Florida, United States
Charleston Neuroscience Inst
🇺🇸Ladson, South Carolina, United States
East Bay Retina Consultants
🇺🇸Oakland, California, United States
VISSUM Instituto Oftalmológico de Alicante
🇪🇸Alicante, Spain
Southern CA Desert Retina Cons
🇺🇸Palm Desert, California, United States
Grupo Laser Vision
🇦🇷Rosario, Argentina
Vanderbilt
🇺🇸Nashville, Tennessee, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Instituto Clinico Quirurgico de Oftalmologia - ICQO
🇪🇸Bilbao, Guipuzcoa, Spain
St. Michael'S Hospital
🇨🇦Toronto, Ontario, Canada
FISABIO. Fundación Oftalmologica del Mediterraneo
🇪🇸Valencia, Spain
Nemocnica sv. Michala, a.s.
🇸🇰Bratislava, Slovakia
Clinica Anglo Americana
🇵🇪Lima, Peru
OFTALMIKA Sp. z o.o
🇵🇱Bydgoszcz, Poland
CHU Brugmann (Victor Horta)
🇧🇪Bruxelles, Belgium
Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche
🇮🇹Roma, Lazio, Italy
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Leids Universitair Medisch Centrum
🇳🇱Leiden, Netherlands
CLINICA RICARDO PALMA; Oftalmologos Contreras
🇵🇪Lima, Peru
SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej
🇵🇱Krakow, Poland
Fakultna nemocnica Trencin Ocna klinika
🇸🇰Trencin, Slovakia
Wake Forest Baptist Health Eye Centre
🇺🇸Winston-Salem, North Carolina, United States
Austin Retina Associates
🇺🇸Austin, Texas, United States
Retina Research Center
🇺🇸Austin, Texas, United States
Eye Surgeons of Richmond Inc. dba Virginia Eye Institute
🇺🇸Richmond, Virginia, United States
Retina Institute of Virginia
🇺🇸Richmond, Virginia, United States