Clinical trial NCT02462928: A Safety and Efficacy Study of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration
Official title: Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration (CEDAR Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Macular Degeneration
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2015-06-04
Enrollment: 939
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of age-related macular degeneration in at least 1 eye
* 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:

* History of vitrectomy, macular surgery, or glaucoma surgery in the study eye
* Cataract or refractive surgery in the study eye within the last 3 months

Primary outcomes:
measure: Percentage of Participants With Stable Vision at Week 52
timeFrame: Baseline to Week 52
Secondary outcomes:
measure: Mean Change From Baseline in BCVA in the Study Eye at Week 52
timeFrame: Baseline to Week 52
measure: Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52
timeFrame: Baseline to Week 52
measure: Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in Study Eye at Week 52
timeFrame: Baseline to Week 52
measure: Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score in Study Eye at Week 52
timeFrame: Baseline to Week 52
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Research Institute, LLC
state: Arizona
city: Phoenix
country: United States
facility: Associated Retina Consultants, Ltd.
state: Arizona
city: Phoenix
country: United States
facility: Arizona Retina and Vitreous Consultants
state: Arizona
city: Tucson
country: United States
facility: Retina Associates Southwest, P.C.
state: Arizona
city: Encino
country: United States
facility: The Retina Partners
state: California
city: Fullerton
country: United States
facility: Retina Consultants of Orange County
state: California
city: Glendora
country: United States
facility: Mark B. Kislinger MD Inc.
state: California
city: Huntington Beach
country: United States
facility: Atlantis Retina Institute (Atlantis Eyecare)
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates Medical Group, INC.
state: California
city: Palm Desert
country: United States
facility: Retina Institute of California
state: California
city: Pasadena
country: United States
facility: Doheny Vision Research
state: California
city: Santa Ana
country: United States
facility: Orange County Retina Medical Group
state: California
city: Santa Barbara
country: United States
facility: California Retina Consultants
state: California
city: South Pasadena
country: United States
facility: Retina Eye Specialists
state: California
city: Golden
country: United States
facility: Colorado Retina Associates
state: Colorado
city: Fort Myers
country: United States
facility: Retina Health Center
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Lakeland
country: United States
facility: Florida Retina Consultants
state: Florida
city: Ocala
country: United States
facility: Ocala Eye PA
state: Florida
city: Orlando
country: United States
facility: Magruder Eye Institute
state: Florida
city: Palm Beach Gardens
country: United States
facility: Retina Care Specialists
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Associates of Florida - Saint Petersburg
state: Florida
city: Tampa
country: United States
facility: USF Eye Institute
state: Florida
city: Marietta
country: United States
facility: Georgia Retina, P.C.
state: Georgia
city: Marietta
country: United States
facility: Marietta Eye Clinic - Main Office
state: Georgia
city: Sandy Springs
country: United States
facility: Thomas Eye Group, PC
state: Georgia
city: 'Aiea
country: United States
facility: Retina Consultants of Hawaii, Inc.
state: Hawaii
city: Bloomington
country: United States
facility: Gailey Eye Clinic
state: Illinois
city: Champaign
country: United States
facility: Carle at the Fields
state: Illinois
city: Lemont
country: United States
facility: University Retina and Macula Associates, PC
state: Illinois
city: Indianapolis
country: United States
facility: Raj K. Maturi, MD, PC
state: Indiana
city: New Albany
country: United States
facility: John Kenyon American Eye Institute
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Health Center
state: Louisiana
city: Baltimore
country: United States
facility: Retina Specialists
state: Maryland
city: Towson
country: United States
facility: The Bert M Glaser National Retina Institute
state: Maryland
city: Peabody
country: United States
facility: Lahey Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: Kellog Eye Center - University of Michigan Health System
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Teaneck
country: United States
facility: Retina Associates of New Jersey
state: New Jersey
city: Albany
country: United States
facility: Capital Region Retina, PLLC
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: Great Neck
country: United States
facility: Long Island Vitreoretinal Consultants
state: New York
city: Oceanside
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Rochester
country: United States
facility: Retina Associates of Western New York
state: New York
city: Shirley
country: United States
facility: Island Retina
state: New York
city: Southern Pines
country: United States
facility: Carolina Eye Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health Eye Center
state: North Carolina
city: Fairfield
country: United States
facility: Apex Eye Clinical Research
state: Ohio
city: Lancaster
country: United States
facility: Lancaster Retina Specialists
state: Pennsylvania
city: Philadelphia
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: West Mifflin
country: United States
facility: Associates in Ophthalmology, Ltd.
state: Pennsylvania
city: Greenville
country: United States
facility: Retina Consultants of Carolina
state: South Carolina
city: Ladson
country: United States
facility: Charleston Neuroscience Institute
state: South Carolina
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Arlington
country: United States
facility: Texas Retina Associates
state: Texas
city: Austin
country: United States
facility: Texan Eye
state: Texas
city: Dallas
country: United States
facility: TX Retina Associates
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates (HEA) - Gramercy Location
state: Texas
city: Houston
country: United States
facility: Retina and Vitreous of Texas
state: Texas
city: Houston
country: United States
facility: Retinal Consultants of Houston
state: Texas
city: San Antonio
country: United States
facility: San Antonio Eye Center
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: San Antonio
country: United States
facility: Retinal Consultants of San Antonio
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Houston
state: Texas
city: Salt Lake City
country: United States
facility: Retina Associates of Utah
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia - Department of Ophthalmology
state: Virginia
city: Lynchburg
country: United States
facility: Piedmont Eye Center, Inc.
state: Virginia
city: Richmond
country: United States
facility: Retina Institute of Virginia
state: Virginia
city: Martinez
country: Argentina
facility: Clinica Privada Kaufer Cataract Center
state: Buenos Aires
city: Pilar
country: Argentina
facility: Hospital Universitario Austral
state: Buenos Aires
city: Rosario
country: Argentina
facility: Centro Oftalmologico Rosario SRL
state: Santa Fe
city: Rosario
country: Argentina
facility: Grupo Laser Vision
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Organizacion Medica de Investigacion
city: Buenos Aires
country: Argentina
facility: Instituto Oftalmologico de Buenos Aires - Oftalmos
city: Cordoba
country: Argentina
facility: Centro Privado de Ojos Romagosa
city: Cordoba
country: Argentina
facility: Instituto Oftalmologico de Cordoba
city: Mendoza
country: Argentina
facility: Oftar Centro Privado de Oftalmologia
city: Graz
country: Austria
facility: Medical University Graz
city: Innsbruck
country: Austria
facility: Medizinische Universitat Innsbruck, Univ.
city: Linz
country: Austria
facility: Kepler Universitatsklinikum GmBH
city: Linz
country: Austria
facility: Konventhospital Barmherzige Brueder Linz
city: Santiago
country: Chile
facility: KYDOFT
state: Las Condes
city: Santiago
country: Chile
facility: Instituto Oftalmologica Profesor Arentsen
state: Región Metropolitana
city: Cali
country: Colombia
facility: Centro Medico Imbanaco
state: Valle Del Cauca
city: Bogota
country: Colombia
facility: Fundacion Oftalmologica Nacional - FUNDONAL
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Praha
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady Oftalmologicka klinika
city: Praha
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze Ocni Klinika
city: Bordeaux
country: France
facility: Hopital Pellegrin
city: Creteil
country: France
facility: Centre Hospitalier Intercommunal de Creteil
city: Lyon cedex 04
country: France
facility: Hopital de la Croix Rousse, Service d'Opthalmologie
city: Nantes Cedex 1
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Centre Ophtalmologique d'Imagerie et de Laser
city: Saint Cyr sur Loire
country: France
facility: Centre Ophtalmologique Saint Exupery
city: Bad Godesberg
country: Germany
facility: Dardenne Eye Hospital
city: Dresden
country: Germany
facility: Klinikum Dresden Friedrichstadt
city: Dusseldorf
country: Germany
facility: Internationale Innovative Ophthalmochirurgie Breyer & Kaymak & Klabe Augenchirurgie
city: Freiburg
country: Germany
facility: Eye Center, University of Freiburg
city: Gottingen
country: Germany
facility: Universitats-augenklinik Gottingen
city: Karlsruhe
country: Germany
facility: Stadtisches Klinikum
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Augenheilkunde
city: Marburg
country: Germany
facility: Universitätsklinikum Giessen und Marburg GmbH
city: Neubrandenburg
country: Germany
facility: Augenklinik im Dietrich-Bonhoeffer - Klinikum Neubrandenburg
city: Regensburg
country: Germany
facility: Clinic and policlinic of ophthalmology, University of Regensburg
city: Aberdeen
country: Hong Kong
facility: The University of Hong Kong
city: Kowloon
country: Hong Kong
facility: The Chinese University of Hong Kong Hongkong eye hospital
city: Haifa
country: Israel
facility: Bnai Zion Medical Center (BZMC) Technion-Israel Institute of Technology
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Haifa
country: Israel
facility: Carmel Medical Center Ophthalmology Clinic
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center Beilinson Hospital
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: TASMC (The Tel-Aviv Sourasky Medical Centre)
city: Tel Hashomer
country: Israel
facility: Chaim Sheba Medical Center Goldschleger Eye Clinic Sheba Medical Center
city: Zerifin
country: Israel
facility: Shamir Medical Centre
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Seocho
country: Korea, Republic of
facility: The Catholic Univ. Of Seoul St. Mary's Hospital
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Serverance Hospital
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital Opthalmology Clinic
state: LV
city: Remuera
country: New Zealand
facility: Auckland Eye
state: Auckland
city: Auckland
country: New Zealand
facility: University of Auckland
city: Cebu City
country: Philippines
facility: Cebu Doctors University Hospital
state: Metro Manila
city: Makati City
country: Philippines
facility: Asian Eye Institute
state: Metro Manila
city: Makati City
country: Philippines
facility: Pacific Eyecare and Laser Institute
state: Metro Manila
city: Pasig City
country: Philippines
facility: The Medical City
state: Metro Manila
city: Quezon City
country: Philippines
facility: St. Luke's Medical Center
state: Metro Manila
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore National Eye Centre- Singapore Eye Research Institute (SNECSERI)
city: Barcelona
country: Spain
facility: Centro de Oftalmologia Barraquer
city: Barcelona
country: Spain
facility: Institut Clinic d'Oftalmologia Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Instituto de Microcirugía Ocular DOS, S.L.U Area de Consultas
city: Barcelona
country: Spain
facility: Hospital Universitario de Bellvitge
city: Barcelona
country: Spain
facility: Valles Oftalmologia Research Hospital
city: Bilbao
country: Spain
facility: Instituto Clínico Quirúrgico de Oftalmología (ICQO)
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra Servicio de Oftalmologia
city: Valencia
country: Spain
facility: Hospital General de Valencia Unidad de Investigacion Clinica
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa. Unidad de Retina Médica y Quirúrgica
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
city: Bern
country: Switzerland
facility: Universitatsklinik fur Augenheilkunde, Inselspital
city: Binningen
country: Switzerland
facility: VISTA Klinik Binningen
city: Zurich
country: Switzerland
facility: Stiftung für wissenschaftliche Forschung am Stadtspital Triemli
Study officials:
affiliation: Allergan
name: Joanne Li
role: STUDY_DIRECTOR
References: