A Safety and Efficacy Study of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration (CEDAR)

July 16, 2020 updated by: Allergan

Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration (CEDAR Study)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

939

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1015ABO
        • Organizacion Medica de Investigacion
      • Buenos Aires, Argentina, C1120AAN
        • Instituto Oftalmologico de Buenos Aires - Oftalmos
      • Cordoba, Argentina, X5000AAJ
        • Centro Privado de Ojos Romagosa
      • Cordoba, Argentina, X5000IIT
        • Instituto Oftalmologico de Cordoba
      • Mendoza, Argentina, M5500GGK
        • Oftar Centro Privado de Oftalmologia
    • Buenos Aires
      • Martinez, Buenos Aires, Argentina, B1640BNT
        • Clinica Privada Kaufer Cataract Center
      • Pilar, Buenos Aires, Argentina, B1629ODT
        • Hospital Universitario Austral
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000ANJ
        • Centro Oftalmologico Rosario SRL
      • Rosario, Santa Fe, Argentina, S2000AZH
        • Grupo Laser Vision
  • Austria
      • Graz, Austria, 8036
        • Medical University Graz
      • Innsbruck, Austria, 6020
        • Medizinische Universitat Innsbruck, Univ.
      • Linz, Austria, 4020
        • Kepler Universitätsklinikum GmbH
      • Linz, Austria, 4021
        • Konventhospital Barmherzige Brueder Linz
  • Chile
    • Las Condes
      • Santiago, Las Condes, Chile, 7560994
        • KYDOFT
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile, 7510168
        • Instituto Oftalmologica Profesor Arentsen
  • Colombia
      • Bogota, Colombia
        • Fundacion Oftalmologica Nacional - FUNDONAL
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760042
        • Centro Médico Imbanaco
  • Czechia
      • Brno, Czechia, 62500
        • Fakultni Nemocnice Brno
      • Olomouc, Czechia, 77900
        • Fakultni nemocnice Olomouc
      • Praha, Czechia, 100 34
        • Fakultni nemocnice Kralovske Vinohrady Oftalmologicka klinika
      • Praha, Czechia, 128 00
        • Vseobecna fakultni nemocnice v Praze Ocni Klinika
  • France
      • Bordeaux, France, 33076
        • Hopital Pellegrin
      • Creteil, France, 94010
        • Centre Hospitalier Intercommunal de Créteil
      • Lyon cedex 04, France, 69417
        • Hopital de la Croix Rousse, Service d'Opthalmologie
      • Nantes Cedex 1, France, 44093
        • CHU de Nantes
      • Paris, France, 75015
        • Centre Ophtalmologique d'Imagerie et de Laser
      • Saint Cyr sur Loire, France, 37540
        • Centre Ophtalmologique Saint Exupéry
  • Germany
      • Bad Godesberg, Germany, 53177
        • Dardenne Eye Hospital
      • Dresden, Germany, 01067
        • Klinikum Dresden Friedrichstadt
      • Dusseldorf, Germany, 40212
        • Internationale Innovative Ophthalmochirurgie Breyer & Kaymak & Klabe Augenchirurgie
      • Freiburg, Germany, 79106
        • Eye Center, University of Freiburg
      • Gottingen, Germany, 37075
        • Universitats-augenklinik Gottingen
      • Karlsruhe, Germany, 76133
        • Städtisches Klinikum
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Augenheilkunde
      • Marburg, Germany, 35043
        • Universitätsklinikum Gießen und Marburg GmbH
      • Neubrandenburg, Germany, 17036
        • Augenklinik im Dietrich-Bonhoeffer - Klinikum Neubrandenburg
      • Regensburg, Germany, 93053
        • Clinic and policlinic of ophthalmology, University of Regensburg
  • Hong Kong
      • Aberdeen, Hong Kong
        • The University of Hong Kong
      • Kowloon, Hong Kong
        • The Chinese University of Hong Kong Hongkong eye hospital
  • Israel
      • Haifa, Israel, 31096
        • Rambam Health Care Campus
      • Haifa, Israel, 31048
        • Bnai Zion Medical Center (BZMC) Technion-Israel Institute of Technology
      • Haifa, Israel, 34362
        • Carmel Medical Center Ophthalmology Clinic
      • Holon, Israel, 58100
        • Edith Wolfson Medical Center
      • Kfar-Saba, Israel, 44281
        • Meir Medical Center
      • Petach Tikva, Israel, 49100
        • Rabin Medical Center Beilinson Hospital
      • Rehovot, Israel, 76100
        • Kaplan Medical Center
      • Tel Aviv, Israel, 64239
        • TASMC (The Tel-Aviv Sourasky Medical Centre)
      • Tel Hashomer, Israel, 52621
        • Chaim Sheba Medical Center Goldschleger Eye Clinic Sheba Medical Center
      • Zerifin, Israel, 70300
        • Shamir Medical Centre
  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 120-752
        • Yonsei University Health System Serverance Hospital
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital
    • Seoul
      • Seocho, Seoul, Korea, Republic of, 137-701
        • The Catholic Univ. Of Seoul St. Mary's Hospital
  • Latvia
    • LV
      • Riga, LV, Latvia, LV-1002
        • Pauls Stradins Clinical University Hospital Opthalmology Clinic
  • New Zealand
      • Auckland, New Zealand, 1123
        • University of Auckland
    • Auckland
      • Remuera, Auckland, New Zealand, 1051
        • Auckland Eye
  • Philippines
    • Metro Manila
      • Cebu City, Metro Manila, Philippines, 6000
        • Cebu Doctors University Hospital
      • Makati City, Metro Manila, Philippines, 1200
        • Asian Eye Institute
      • Makati City, Metro Manila, Philippines, 1209
        • Pacific Eyecare and Laser Institute
      • Pasig City, Metro Manila, Philippines, 1600
        • The Medical City
      • Quezon City, Metro Manila, Philippines, 1102
        • St. Luke's Medical Center
  • Singapore
      • Singapore, Singapore, 119228
        • National University Hospital
      • Singapore, Singapore, 168751
        • Singapore National Eye Centre- Singapore Eye Research Institute (SNECSERI)
  • Spain
      • Barcelona, Spain, 08907
        • Hospital Universitario de Bellvitge
      • Barcelona, Spain, 08021
        • Centro de Oftalmologia Barraquer
      • Barcelona, Spain, 08028
        • Institut Clinic d'Oftalmologia Hospital Clinic de Barcelona
      • Barcelona, Spain, 08035
        • Instituto de Microcirugía Ocular DOS, S.L.U Area de Consultas
      • Barcelona, Spain, 08915
        • Valles Oftalmologia Research Hospital
      • Bilbao, Spain, 48006
        • Instituto Clínico Quirúrgico de Oftalmología (ICQO)
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Pamplona, Spain, 31008
        • Clinica Universidad de Navarra Servicio de Oftalmologia
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
      • Valencia, Spain, 46014
        • Hospital General de Valencia Unidad de Investigacion Clinica
      • Valladolid, Spain, 47005
        • Hospital Clínico Universitario
      • Zaragoza, Spain, 50009
        • Hospital Miguel Servet
      • Zaragoza, Spain, 50009
        • Hospital Clínico Universitario Lozano Blesa. Unidad de Retina Médica y Quirúrgica
  • Switzerland
      • Bern, Switzerland, 3010
        • Universitatsklinik fur Augenheilkunde, Inselspital
      • Binningen, Switzerland, 4102
        • Vista Klinik Binningen
      • Zurich, Switzerland, 8063
        • Stiftung für wissenschaftliche Forschung am Stadtspital Triemli
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Retinal Research Institute, LLC
      • Phoenix, Arizona, United States, 85021
        • Arizona Retina and Vitreous Consultants
      • Phoenix, Arizona, United States, 85020
        • Associated Retina Consultants, Ltd.
      • Tucson, Arizona, United States, 85710
        • Retina Associates Southwest, P.C.
    • California
      • Encino, California, United States, 91436
        • The Retina Partners
      • Fullerton, California, United States, 92835
        • Retina Consultants of Orange County
      • Glendora, California, United States, 91741
        • Mark B. Kislinger MD Inc.
      • Huntington Beach, California, United States, 92647
        • Atlantis Retina Institute (Atlantis Eyecare)
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center
      • Mountain View, California, United States, 94040
        • Northern California Retina Vitreous Associates Medical Group, Inc.
      • Palm Desert, California, United States, 92260
        • Retina Institute of California
      • Pasadena, California, United States, 91105
        • Doheny Vision Research
      • Santa Ana, California, United States, 92705
        • Orange County Retina Medical Group
      • Santa Barbara, California, United States, 93103
        • California Retina Consultants
      • South Pasadena, California, United States, 91030
        • Retina Eye Specialists
    • Colorado
      • Golden, Colorado, United States, 80401
        • Colorado Retina Associates
    • Florida
      • Fort Myers, Florida, United States, 33907
        • Retina Health Center
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida
      • Lakeland, Florida, United States, 33805
        • Florida Retina Consultants
      • Ocala, Florida, United States, 34474
        • Ocala Eye PA
      • Orlando, Florida, United States, 32803
        • Magruder Eye Institute
      • Palm Beach Gardens, Florida, United States, 33410
        • Retina Care Specialists
      • Pensacola, Florida, United States, 32503
        • Retina Specialty Institute
      • Saint Petersburg, Florida, United States, 33711
        • Retina Vitreous Associates of Florida - Saint Petersburg
      • Tampa, Florida, United States, 33612
        • USF Eye Institute
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Georgia Retina, P.C.
      • Marietta, Georgia, United States, 30060
        • Marietta Eye Clinic - Main Office
      • Sandy Springs, Georgia, United States, 30328
        • Thomas Eye Group, PC
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • Retina Consultants of Hawaii, Inc.
    • Illinois
      • Bloomington, Illinois, United States, 61704
        • Gailey Eye Clinic
      • Champaign, Illinois, United States, 61822
        • Carle at the Fields
      • Lemont, Illinois, United States, 60439
        • University Retina and Macula Associates, PC
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Raj K. Maturi, MD, PC
      • New Albany, Indiana, United States, 47150
        • John Kenyon American Eye Institute
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Health Center
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Retina Specialists
      • Towson, Maryland, United States, 21204
        • The Bert M Glaser National Retina Institute
    • Massachusetts
      • Peabody, Massachusetts, United States, 01960
        • Lahey Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Kellog Eye Center - University of Michigan Health System
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Eye Associates
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Retina Associates of New Jersey
    • New York
      • Albany, New York, United States, 12206
        • Capital Region Retina, PLLC
      • Brooklyn, New York, United States, 11201
        • SUNY Downstate Medical Center
      • Great Neck, New York, United States, 11021
        • Long Island Vitreoretinal Consultants
      • Oceanside, New York, United States, 11572
        • Ophthalmic Consultants of Long Island
      • Rochester, New York, United States, 14620
        • Retina Associates of Western New York
      • Shirley, New York, United States, 11967
        • Island Retina
    • North Carolina
      • Southern Pines, North Carolina, United States, 28387
        • Carolina Eye Associates
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health Eye Center
    • Ohio
      • Fairfield, Ohio, United States, 45014
        • Apex Eye Clinical Research
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17601
        • Lancaster Retina Specialists
      • Philadelphia, Pennsylvania, United States, 19107
        • Mid Atlantic Retina
      • West Mifflin, Pennsylvania, United States, 15122
        • Associates in Ophthalmology, Ltd.
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Retina Consultants of Carolina
      • Ladson, South Carolina, United States, 29456
        • Charleston Neuroscience Institute
    • Texas
      • Abilene, Texas, United States, 79606
        • Retina Research Institute of Texas
      • Arlington, Texas, United States, 76012
        • Texas Retina Associates
      • Austin, Texas, United States, 78731
        • Texan Eye
      • Dallas, Texas, United States, 75231
        • TX Retina Associates
      • Houston, Texas, United States, 77025
        • Retina and Vitreous of Texas
      • Houston, Texas, United States, 77030
        • Retinal Consultants of Houston
      • Houston, Texas, United States, 77025
        • Houston Eye Associates (HEA) - Gramercy Location
      • San Antonio, Texas, United States, 78240
        • Medical Center Ophthalmology Associates
      • San Antonio, Texas, United States, 78240
        • Retinal Consultants of San Antonio
      • San Antonio, Texas, United States, 78215
        • San Antonio Eye Center
      • The Woodlands, Texas, United States, 77384
        • Retina Consultants of Houston
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Retina Associates of Utah
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia - Department of Ophthalmology
      • Lynchburg, Virginia, United States, 24502
        • Piedmont Eye Center, Inc.
      • Richmond, Virginia, United States, 23235
        • Retina Institute of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Abicipar Pegol
Abicipar pegol intravitreal injection.
Other Names:
  • AGN-150998
Other: Sham Procedure
Sham injection.
Experimental: 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.
Drug: Abicipar Pegol
Abicipar pegol intravitreal injection.
Other Names:
  • AGN-150998
Other: Sham Procedure
Sham injection.
Active Comparator: 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.
Drug: Ranibizumab
Ranibizumab intravitreal injection.
Other Names:
  • Lucentis®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Stable Vision at Week 52
Time Frame: Baseline to 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in BCVA in the Study Eye at Week 52
Time Frame: Baseline to Week 52
BCVA was measured using an eye chart and was reported as the number of letters read correctly using the 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 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 nondominant eye for treatment, or else the right eye was selected as the study eye. Mixed model for repeated measures (MMRM) analysis was used.
Baseline to Week 52
Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52
Time Frame: Baseline to Week 52
CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement. 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. MMRM analysis was used.
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
Time Frame: Baseline to Week 52
BCVA was measured using an eye chart and reported as the number of letters read correctly using the 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 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
Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score in Study Eye at Week 52
Time Frame: Baseline to Week 52
NEI-VFQ-25 consists of 25 vision-targeted questions that represent 11 vision-related quality of life subscales and one general health item. Responses of individual participants were recorded as scores that ranged between 0 (worst) to 100 (best vision related function) with higher scale indicating better vision related function. The overall composite score is then calculated by averaging over all 11 vision-targeted subscale scores, excluding the general health score. Overall composite score was calculated based on mean of non-missing subscales. Study eye was defined as eye that meets entry criteria. If both eyes met all of entry criteria, eye with worse BCVA at baseline (day 1) was selected. If BCVA values for both eyes were identical then participant had to select non-dominant eye, or else right eye was selected as study eye. A positive change from baseline indicates improvement. MMRM analysis was used.
Baseline to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Investigators

  • Study Director: Joanne Li, Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2015

Primary Completion (Actual)

April 18, 2018

Study Completion (Actual)

June 19, 2019

Study Registration Dates

First Submitted

June 2, 2015

First Submitted That Met QC Criteria

June 2, 2015

First Posted (Estimate)

June 4, 2015

Study Record Updates

Last Update Posted (Actual)

July 28, 2020

Last Update Submitted That Met QC Criteria

July 16, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 150998-005
  • CEDAR (Other Identifier: Allergan)
  • 2014-004579-22 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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