A Safety and Efficacy Study of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration
CEDAR
Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration (CEDAR Study)
3 other identifiers
interventional
939
17 countries
151
Brief Summary
This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2015
Typical duration for phase_3
151 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2015
CompletedFirst Posted
Study publicly available on registry
June 4, 2015
CompletedStudy Start
First participant enrolled
June 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2019
CompletedResults Posted
Study results publicly available
July 28, 2020
CompletedJuly 28, 2020
July 1, 2020
2.8 years
June 2, 2015
July 16, 2020
July 16, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Stable Vision at Week 52
Stable vision was defined as a loss of fewer than 15 letters in BCVA compared to baseline. BCVA was measured using an eye chart and reported as the number of letters read correctly using the Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (ranging 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). An increase in the number of letters read correctly means that vision has improved. The percentage of participants with a BCVA loss of fewer than 15 letters are reported. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
Baseline to Week 52
Secondary Outcomes (4)
Mean Change From Baseline in BCVA in the Study Eye at Week 52
Baseline to Week 52
Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52
Baseline to Week 52
Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in Study Eye at Week 52
Baseline to Week 52
Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score in Study Eye at Week 52
Baseline to Week 52
Study Arms (3)
Abicipar Pegol 2 mg (2Q8)
EXPERIMENTALAbicipar 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 2 mg (2Q12)
EXPERIMENTALAbicipar 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.
Ranibizumab 0.5 mg (rQ4)
ACTIVE COMPARATORRanibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
Interventions
Abicipar pegol intravitreal injection.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (151)
Retinal Research Institute, LLC
Phoenix, Arizona, 85014, United States
Associated Retina Consultants, Ltd.
Phoenix, Arizona, 85020, United States
Arizona Retina and Vitreous Consultants
Phoenix, Arizona, 85021, United States
Retina Associates Southwest, P.C.
Tucson, Arizona, 85710, United States
The Retina Partners
Encino, California, 91436, United States
Retina Consultants of Orange County
Fullerton, California, 92835, United States
Mark B. Kislinger MD Inc.
Glendora, California, 91741, United States
Atlantis Retina Institute (Atlantis Eyecare)
Huntington Beach, California, 92647, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Northern California Retina Vitreous Associates Medical Group, INC.
Mountain View, California, 94040, United States
Retina Institute of California
Palm Desert, California, 92260, United States
Doheny Vision Research
Pasadena, California, 91105, United States
Orange County Retina Medical Group
Santa Ana, California, 92705, United States
California Retina Consultants
Santa Barbara, California, 93103, United States
Retina Eye Specialists
South Pasadena, California, 91030, United States
Colorado Retina Associates
Golden, Colorado, 80401, United States
Retina Health Center
Fort Myers, Florida, 33907, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Florida Retina Consultants
Lakeland, Florida, 33805, United States
Ocala Eye PA
Ocala, Florida, 34474, United States
Magruder Eye Institute
Orlando, Florida, 32803, United States
Retina Care Specialists
Palm Beach Gardens, Florida, 33410, United States
Retina Specialty Institute
Pensacola, Florida, 32503, United States
Retina Vitreous Associates of Florida - Saint Petersburg
St. Petersburg, Florida, 33711, United States
USF Eye Institute
Tampa, Florida, 33612, United States
Georgia Retina, P.C.
Marietta, Georgia, 30060, United States
Marietta Eye Clinic - Main Office
Marietta, Georgia, 30060, United States
Thomas Eye Group, PC
Sandy Springs, Georgia, 30328, United States
Retina Consultants of Hawaii, Inc.
‘Aiea, Hawaii, 96701, United States
Gailey Eye Clinic
Bloomington, Illinois, 61704, United States
Carle at the Fields
Champaign, Illinois, 61822, United States
University Retina and Macula Associates, PC
Lemont, Illinois, 60439, United States
Raj K. Maturi, MD, PC
Indianapolis, Indiana, 46290, United States
John Kenyon American Eye Institute
New Albany, Indiana, 47150, United States
Ochsner Health Center
New Orleans, Louisiana, 70121, United States
Retina Specialists
Baltimore, Maryland, 21204, United States
The Bert M Glaser National Retina Institute
Towson, Maryland, 21204, United States
Lahey Medical Center
Peabody, Massachusetts, 01960, United States
Kellog Eye Center - University of Michigan Health System
Ann Arbor, Michigan, 48105, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Sierra Eye Associates
Reno, Nevada, 89502, United States
Retina Associates of New Jersey
Teaneck, New Jersey, 07666, United States
Capital Region Retina, PLLC
Albany, New York, 12206, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11201, United States
Long Island Vitreoretinal Consultants
Great Neck, New York, 11021, United States
Ophthalmic Consultants of Long Island
Oceanside, New York, 11572, United States
Retina Associates of Western New York
Rochester, New York, 14620, United States
Island Retina
Shirley, New York, 11967, United States
Carolina Eye Associates
Southern Pines, North Carolina, 28387, United States
Wake Forest Baptist Health Eye Center
Winston-Salem, North Carolina, 27157, United States
Apex Eye Clinical Research
Fairfield, Ohio, 45014, United States
Lancaster Retina Specialists
Lancaster, Pennsylvania, 17601, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107, United States
Associates in Ophthalmology, Ltd.
West Mifflin, Pennsylvania, 15122, United States
Retina Consultants of Carolina
Greenville, South Carolina, 29605, United States
Charleston Neuroscience Institute
Ladson, South Carolina, 29456, United States
Retina Research Institute of Texas
Abilene, Texas, 79606, United States
Texas Retina Associates
Arlington, Texas, 76012, United States
Texan Eye
Austin, Texas, 78731, United States
TX Retina Associates
Dallas, Texas, 75231, United States
Houston Eye Associates (HEA) - Gramercy Location
Houston, Texas, 77025, United States
Retina and Vitreous of Texas
Houston, Texas, 77025, United States
Retinal Consultants of Houston
Houston, Texas, 77030, United States
San Antonio Eye Center
San Antonio, Texas, 78215, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240, United States
Retinal Consultants of San Antonio
San Antonio, Texas, 78240, United States
Retina Consultants of Houston
The Woodlands, Texas, 77384, United States
Retina Associates of Utah
Salt Lake City, Utah, 84107, United States
University of Virginia - Department of Ophthalmology
Charlottesville, Virginia, 22908, United States
Piedmont Eye Center, Inc.
Lynchburg, Virginia, 24502, United States
Retina Institute of Virginia
Richmond, Virginia, 23235, United States
Clinica Privada Kaufer Cataract Center
Martínez, Buenos Aires, B1640BNT, Argentina
Hospital Universitario Austral
Pilar, Buenos Aires, B1629ODT, Argentina
Centro Oftalmologico Rosario SRL
Rosario, Santa Fe Province, S2000ANJ, Argentina
Grupo Laser Vision
Rosario, Santa Fe Province, S2000AZH, Argentina
Organizacion Medica de Investigacion
Buenos Aires, C1015ABO, Argentina
Instituto Oftalmologico de Buenos Aires - Oftalmos
Buenos Aires, C1120AAN, Argentina
Centro Privado de Ojos Romagosa
Córdoba, X5000AAJ, Argentina
Instituto Oftalmologico de Cordoba
Córdoba, X5000IIT, Argentina
Oftar Centro Privado de Oftalmologia
Mendoza, M5500GGK, Argentina
Medical University Graz
Graz, 8036, Austria
Medizinische Universitat Innsbruck, Univ.
Innsbruck, 6020, Austria
Kepler Universitatsklinikum GmBH
Linz, 4020, Austria
Konventhospital Barmherzige Brueder Linz
Linz, 4021, Austria
KYDOFT
Santiago, Las Condes, 7560994, Chile
Instituto Oftalmologica Profesor Arentsen
Santiago, Santiago Metropolitan, 7510168, Chile
Centro Medico Imbanaco
Cali, Valle del Cauca Department, 760042, Colombia
Fundacion Oftalmologica Nacional - FUNDONAL
Bogotá, Colombia
Fakultni nemocnice Brno
Brno, 62500, Czechia
Fakultni nemocnice Olomouc
Olomouc, 77900, Czechia
Fakultni nemocnice Kralovske Vinohrady Oftalmologicka klinika
Prague, 100 34, Czechia
Vseobecna fakultni nemocnice v Praze Ocni Klinika
Prague, 128 00, Czechia
Hopital Pellegrin
Bordeaux, 33076, France
Centre Hospitalier Intercommunal de Creteil
Créteil, 94010, France
Hopital de la Croix Rousse, Service d'Opthalmologie
Lyon, 69417, France
CHU de Nantes
Nantes, 44093, France
Centre Ophtalmologique d'Imagerie et de Laser
Paris, 75015, France
Centre Ophtalmologique Saint Exupery
Saint-Cyr-sur-Loire, 37540, France
Dardenne Eye Hospital
Bad Godesberg, 53177, Germany
Klinikum Dresden Friedrichstadt
Dresden, 01067, Germany
Internationale Innovative Ophthalmochirurgie Breyer & Kaymak & Klabe Augenchirurgie
Düsseldorf, 40212, Germany
Eye Center, University of Freiburg
Freiburg im Breisgau, 79106, Germany
Universitats-augenklinik Gottingen
Göttingen, 37075, Germany
Stadtisches Klinikum
Karlsruhe, 76133, Germany
Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Augenheilkunde
Leipzig, 04103, Germany
Universitätsklinikum Giessen und Marburg GmbH
Marburg, 35043, Germany
Augenklinik im Dietrich-Bonhoeffer - Klinikum Neubrandenburg
Neubrandenburg, 17036, Germany
Clinic and policlinic of ophthalmology, University of Regensburg
Regensburg, 93053, 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, 31048, Israel
Rambam Health Care Campus
Haifa, 31096, Israel
Carmel Medical Center Ophthalmology Clinic
Haifa, 34362, Israel
Edith Wolfson Medical Center
Holon, 58100, Israel
Meir Medical Center
Kfar Saba, 44281, Israel
Rabin Medical Center Beilinson Hospital
Petah Tikva, 49100, Israel
Kaplan Medical Center
Rehovot, 76100, Israel
TASMC (The Tel-Aviv Sourasky Medical Centre)
Tel Aviv, 64239, Israel
Chaim Sheba Medical Center Goldschleger Eye Clinic Sheba Medical Center
Tel Litwinsky, 52621, Israel
Shamir Medical Centre
Ẕerifin, 70300, Israel
Pauls Stradins Clinical University Hospital Opthalmology Clinic
Riga, LV, LV-1002, Latvia
Auckland Eye
Remuera, Auckland, 1051, New Zealand
University of Auckland
Auckland, 1123, New Zealand
Cebu Doctors University Hospital
Cebu City, National Capital Region, 6000, Philippines
Asian Eye Institute
Makati City, National Capital Region, 1200, Philippines
Pacific Eyecare and Laser Institute
Makati City, National Capital Region, 1209, Philippines
The Medical City
Pasig, National Capital Region, 1600, Philippines
St. Luke's Medical Center
Quezon City, National Capital Region, 1102, Philippines
National University Hospital
Singapore, 119228, Singapore
Singapore National Eye Centre- Singapore Eye Research Institute (SNECSERI)
Singapore, 168751, Singapore
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
The Catholic Univ. Of Seoul St. Mary's Hospital
Seocho, Seoul, 137-701, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Yonsei University Health System Serverance Hospital
Seoul, 120-752, South Korea
Centro de Oftalmologia Barraquer
Barcelona, 08021, Spain
Institut Clinic d'Oftalmologia Hospital Clinic de Barcelona
Barcelona, 08028, Spain
Instituto de Microcirugía Ocular DOS, S.L.U Area de Consultas
Barcelona, 08035, Spain
Hospital Universitario de Bellvitge
Barcelona, 08907, Spain
Valles Oftalmologia Research Hospital
Barcelona, 08915, Spain
Instituto Clínico Quirúrgico de Oftalmología (ICQO)
Bilbao, 48006, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Clinica Universidad de Navarra Servicio de Oftalmologia
Pamplona, 31008, Spain
Hospital General de Valencia Unidad de Investigacion Clinica
Valencia, 46014, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Hospital Clinico Universitario
Valladolid, 47005, Spain
Hospital Clínico Universitario Lozano Blesa. Unidad de Retina Médica y Quirúrgica
Zaragoza, 50009, Spain
Hospital Miguel Servet
Zaragoza, 50009, Spain
Universitatsklinik fur Augenheilkunde, Inselspital
Bern, 3010, Switzerland
VISTA Klinik Binningen
Binningen, 4102, Switzerland
Stiftung für wissenschaftliche Forschung am Stadtspital Triemli
Zurich, 8063, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Joanne Li
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2015
First Posted
June 4, 2015
Study Start
June 25, 2015
Primary Completion
April 18, 2018
Study Completion
June 19, 2019
Last Updated
July 28, 2020
Results First Posted
July 28, 2020
Record last verified: 2020-07