A Safety and Efficacy Study of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration
NCT ID: NCT02462928
Last Updated: 2020-07-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
939 participants
INTERVENTIONAL
2015-06-25
2019-06-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Abicipar Pegol 2 mg (2Q8)
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
Abicipar Pegol
Abicipar pegol intravitreal injection.
Sham Procedure
Sham injection.
Abicipar Pegol 2 mg (2Q12)
Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter through week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
Abicipar Pegol
Abicipar pegol intravitreal injection.
Sham Procedure
Sham injection.
Ranibizumab 0.5 mg (rQ4)
Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
Ranibizumab
Ranibizumab intravitreal injection.
Interventions
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Abicipar Pegol
Abicipar pegol intravitreal injection.
Ranibizumab
Ranibizumab intravitreal injection.
Sham Procedure
Sham injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Best corrected visual acuity of 20/40 to 20/320 in the study eye
* Best corrected visual acuity of 20/200 or better in the non-study eye
Exclusion Criteria
* Cataract or refractive surgery in the study eye within the last 3 months
50 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Joanne Li
Role: STUDY_DIRECTOR
Allergan
Locations
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Retinal Research Institute, LLC
Phoenix, Arizona, United States
Associated Retina Consultants, Ltd.
Phoenix, Arizona, United States
Arizona Retina and Vitreous Consultants
Phoenix, Arizona, United States
Retina Associates Southwest, P.C.
Tucson, Arizona, United States
The Retina Partners
Encino, California, United States
Retina Consultants of Orange County
Fullerton, California, United States
Mark B. Kislinger MD Inc.
Glendora, California, United States
Atlantis Retina Institute (Atlantis Eyecare)
Huntington Beach, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Northern California Retina Vitreous Associates Medical Group, INC.
Mountain View, California, United States
Retina Institute of California
Palm Desert, California, United States
Doheny Vision Research
Pasadena, California, United States
Orange County Retina Medical Group
Santa Ana, California, United States
California Retina Consultants
Santa Barbara, California, United States
Retina Eye Specialists
South Pasadena, California, United States
Colorado Retina Associates
Golden, Colorado, United States
Retina Health Center
Fort Myers, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Florida Retina Consultants
Lakeland, Florida, United States
Ocala Eye PA
Ocala, Florida, United States
Magruder Eye Institute
Orlando, Florida, United States
Retina Care Specialists
Palm Beach Gardens, Florida, United States
Retina Specialty Institute
Pensacola, Florida, United States
Retina Vitreous Associates of Florida - Saint Petersburg
St. Petersburg, Florida, United States
USF Eye Institute
Tampa, Florida, United States
Georgia Retina, P.C.
Marietta, Georgia, United States
Marietta Eye Clinic - Main Office
Marietta, Georgia, United States
Thomas Eye Group, PC
Sandy Springs, Georgia, United States
Retina Consultants of Hawaii, Inc.
‘Aiea, Hawaii, United States
Gailey Eye Clinic
Bloomington, Illinois, United States
Carle at the Fields
Champaign, Illinois, United States
University Retina and Macula Associates, PC
Lemont, Illinois, United States
Raj K. Maturi, MD, PC
Indianapolis, Indiana, United States
John Kenyon American Eye Institute
New Albany, Indiana, United States
Ochsner Health Center
New Orleans, Louisiana, United States
Retina Specialists
Baltimore, Maryland, United States
The Bert M Glaser National Retina Institute
Towson, Maryland, United States
Lahey Medical Center
Peabody, Massachusetts, United States
Kellog Eye Center - University of Michigan Health System
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Sierra Eye Associates
Reno, Nevada, United States
Retina Associates of New Jersey
Teaneck, New Jersey, United States
Capital Region Retina, PLLC
Albany, New York, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
Long Island Vitreoretinal Consultants
Great Neck, New York, United States
Ophthalmic Consultants of Long Island
Oceanside, New York, United States
Retina Associates of Western New York
Rochester, New York, United States
Island Retina
Shirley, New York, United States
Carolina Eye Associates
Southern Pines, North Carolina, United States
Wake Forest Baptist Health Eye Center
Winston-Salem, North Carolina, United States
Apex Eye Clinical Research
Fairfield, Ohio, United States
Lancaster Retina Specialists
Lancaster, Pennsylvania, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, United States
Associates in Ophthalmology, Ltd.
West Mifflin, Pennsylvania, United States
Retina Consultants of Carolina
Greenville, South Carolina, United States
Charleston Neuroscience Institute
Ladson, South Carolina, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Texas Retina Associates
Arlington, Texas, United States
Texan Eye
Austin, Texas, United States
TX Retina Associates
Dallas, Texas, United States
Houston Eye Associates (HEA) - Gramercy Location
Houston, Texas, United States
Retina and Vitreous of Texas
Houston, Texas, United States
Retinal Consultants of Houston
Houston, Texas, United States
San Antonio Eye Center
San Antonio, Texas, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Retinal Consultants of San Antonio
San Antonio, Texas, United States
Retina Consultants of Houston
The Woodlands, Texas, United States
Retina Associates of Utah
Salt Lake City, Utah, United States
University of Virginia - Department of Ophthalmology
Charlottesville, Virginia, United States
Piedmont Eye Center, Inc.
Lynchburg, Virginia, United States
Retina Institute of Virginia
Richmond, Virginia, United States
Clinica Privada Kaufer Cataract Center
Martínez, Buenos Aires, Argentina
Hospital Universitario Austral
Pilar, Buenos Aires, Argentina
Centro Oftalmologico Rosario SRL
Rosario, Santa Fe Province, Argentina
Grupo Laser Vision
Rosario, Santa Fe Province, Argentina
Organizacion Medica de Investigacion
Buenos Aires, , Argentina
Instituto Oftalmologico de Buenos Aires - Oftalmos
Buenos Aires, , Argentina
Centro Privado de Ojos Romagosa
Córdoba, , Argentina
Instituto Oftalmologico de Cordoba
Córdoba, , Argentina
Oftar Centro Privado de Oftalmologia
Mendoza, , Argentina
Medical University Graz
Graz, , Austria
Medizinische Universitat Innsbruck, Univ.
Innsbruck, , Austria
Kepler Universitatsklinikum GmBH
Linz, , Austria
Konventhospital Barmherzige Brueder Linz
Linz, , Austria
KYDOFT
Santiago, Las Condes, Chile
Instituto Oftalmologica Profesor Arentsen
Santiago, Santiago Metropolitan, Chile
Centro Medico Imbanaco
Cali, Valle del Cauca Department, Colombia
Fundacion Oftalmologica Nacional - FUNDONAL
Bogotá, , Colombia
Fakultni nemocnice Brno
Brno, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Fakultni nemocnice Kralovske Vinohrady Oftalmologicka klinika
Prague, , Czechia
Vseobecna fakultni nemocnice v Praze Ocni Klinika
Prague, , Czechia
Hopital Pellegrin
Bordeaux, , France
Centre Hospitalier Intercommunal de Creteil
Créteil, , France
Hopital de la Croix Rousse, Service d'Opthalmologie
Lyon, , France
CHU de Nantes
Nantes, , France
Centre Ophtalmologique d'Imagerie et de Laser
Paris, , France
Centre Ophtalmologique Saint Exupery
Saint-Cyr-sur-Loire, , France
Dardenne Eye Hospital
Bad Godesberg, , Germany
Klinikum Dresden Friedrichstadt
Dresden, , Germany
Internationale Innovative Ophthalmochirurgie Breyer & Kaymak & Klabe Augenchirurgie
Düsseldorf, , Germany
Eye Center, University of Freiburg
Freiburg im Breisgau, , Germany
Universitats-augenklinik Gottingen
Göttingen, , Germany
Stadtisches Klinikum
Karlsruhe, , Germany
Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Augenheilkunde
Leipzig, , Germany
Universitätsklinikum Giessen und Marburg GmbH
Marburg, , Germany
Augenklinik im Dietrich-Bonhoeffer - Klinikum Neubrandenburg
Neubrandenburg, , Germany
Clinic and policlinic of ophthalmology, University of Regensburg
Regensburg, , Germany
The University of Hong Kong
Aberdeen, , Hong Kong
The Chinese University of Hong Kong Hongkong eye hospital
Kowloon, , Hong Kong
Bnai Zion Medical Center (BZMC) Technion-Israel Institute of Technology
Haifa, , Israel
Rambam Health Care Campus
Haifa, , Israel
Carmel Medical Center Ophthalmology Clinic
Haifa, , Israel
Edith Wolfson Medical Center
Holon, , Israel
Meir Medical Center
Kfar Saba, , Israel
Rabin Medical Center Beilinson Hospital
Petah Tikva, , Israel
Kaplan Medical Center
Rehovot, , Israel
TASMC (The Tel-Aviv Sourasky Medical Centre)
Tel Aviv, , Israel
Chaim Sheba Medical Center Goldschleger Eye Clinic Sheba Medical Center
Tel Litwinsky, , Israel
Shamir Medical Centre
Ẕerifin, , Israel
Pauls Stradins Clinical University Hospital Opthalmology Clinic
Riga, LV, Latvia
Auckland Eye
Remuera, Auckland, New Zealand
University of Auckland
Auckland, , New Zealand
Cebu Doctors University Hospital
Cebu City, National Capital Region, Philippines
Asian Eye Institute
Makati City, National Capital Region, Philippines
Pacific Eyecare and Laser Institute
Makati City, National Capital Region, Philippines
The Medical City
Pasig, National Capital Region, Philippines
St. Luke's Medical Center
Quezon City, National Capital Region, Philippines
National University Hospital
Singapore, , Singapore
Singapore National Eye Centre- Singapore Eye Research Institute (SNECSERI)
Singapore, , Singapore
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
The Catholic Univ. Of Seoul St. Mary's Hospital
Seocho, Seoul, South Korea
Asan Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Yonsei University Health System Serverance Hospital
Seoul, , South Korea
Centro de Oftalmologia Barraquer
Barcelona, , Spain
Institut Clinic d'Oftalmologia Hospital Clinic de Barcelona
Barcelona, , Spain
Instituto de Microcirugía Ocular DOS, S.L.U Area de Consultas
Barcelona, , Spain
Hospital Universitario de Bellvitge
Barcelona, , Spain
Valles Oftalmologia Research Hospital
Barcelona, , Spain
Instituto Clínico Quirúrgico de Oftalmología (ICQO)
Bilbao, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Clinica Universidad de Navarra Servicio de Oftalmologia
Pamplona, , Spain
Hospital General de Valencia Unidad de Investigacion Clinica
Valencia, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Hospital Clinico Universitario
Valladolid, , Spain
Hospital Clínico Universitario Lozano Blesa. Unidad de Retina Médica y Quirúrgica
Zaragoza, , Spain
Hospital Miguel Servet
Zaragoza, , Spain
Universitatsklinik fur Augenheilkunde, Inselspital
Bern, , Switzerland
VISTA Klinik Binningen
Binningen, , Switzerland
Stiftung für wissenschaftliche Forschung am Stadtspital Triemli
Zurich, , Switzerland
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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2014-004579-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CEDAR
Identifier Type: OTHER
Identifier Source: secondary_id
150998-005
Identifier Type: -
Identifier Source: org_study_id
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