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Macular DegenerationPhase 3CEDARNCT02462928

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

A Phase 3 study testing Abicipar Pegol and Ranibizumab in people with Macular Degeneration, run by Allergan at 151 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 50 years and older
Conditions the study is for
Macular Degeneration
What is being tested?
Abicipar Pegol and Ranibizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
939 participants
Where
151 sitesin 17 countries
Study dates
25 Jun 2015to 19 Jun 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

151 sites in 17 countries.

151 sites in 17 countries

United States71 sites

  • Retina Consultants of Hawaii, Inc.

    ‘Aiea, Hawaii, 96701

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Capital Region Retina, PLLC

    Albany, New York, 12206

  • Kellog Eye Center - University of Michigan Health System

    Ann Arbor, Michigan, 48105

  • Texas Retina Associates

    Arlington, Texas, 76012

  • Texan Eye

    Austin, Texas, 78731

  • Retina Specialists

    Baltimore, Maryland, 21204

  • Gailey Eye Clinic

    Bloomington, Illinois, 61704

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11201

  • Carle at the Fields

    Champaign, Illinois, 61822

  • University of Virginia - Department of Ophthalmology

    Charlottesville, Virginia, 22908

  • TX Retina Associates

    Dallas, Texas, 75231

  • The Retina Partners

    Encino, California, 91436

  • Apex Eye Clinical Research

    Fairfield, Ohio, 45014

  • Retina Health Center

    Fort Myers, Florida, 33907

  • Retina Consultants of Orange County

    Fullerton, California, 92835

  • Mark B. Kislinger MD Inc.

    Glendora, California, 91741

  • Colorado Retina Associates

    Golden, Colorado, 80401

  • Long Island Vitreoretinal Consultants

    Great Neck, New York, 11021

  • Retina Consultants of Carolina

    Greenville, South Carolina, 29605

  • Houston Eye Associates (HEA) - Gramercy Location

    Houston, Texas, 77025

  • Retina and Vitreous of Texas

    Houston, Texas, 77025

  • Retinal Consultants of Houston

    Houston, Texas, 77030

  • Atlantis Retina Institute (Atlantis Eyecare)

    Huntington Beach, California, 92647

  • Raj K. Maturi, MD, PC

    Indianapolis, Indiana, 46290

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

  • Charleston Neuroscience Institute

    Ladson, South Carolina, 29456

  • Florida Retina Consultants

    Lakeland, Florida, 33805

  • Lancaster Retina Specialists

    Lancaster, Pennsylvania, 17601

  • University Retina and Macula Associates, PC

    Lemont, Illinois, 60439

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Piedmont Eye Center, Inc.

    Lynchburg, Virginia, 24502

  • Georgia Retina, P.C.

    Marietta, Georgia, 30060

  • Marietta Eye Clinic - Main Office

    Marietta, Georgia, 30060

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Northern California Retina Vitreous Associates Medical Group, INC.

    Mountain View, California, 94040

  • John Kenyon American Eye Institute

    New Albany, Indiana, 47150

  • Ochsner Health Center

    New Orleans, Louisiana, 70121

  • Ocala Eye PA

    Ocala, Florida, 34474

  • Ophthalmic Consultants of Long Island

    Oceanside, New York, 11572

  • Magruder Eye Institute

    Orlando, Florida, 32803

  • Retina Care Specialists

    Palm Beach Gardens, Florida, 33410

  • Retina Institute of California

    Palm Desert, California, 92260

  • Doheny Vision Research

    Pasadena, California, 91105

  • Lahey Medical Center

    Peabody, Massachusetts, 01960

  • Retina Specialty Institute

    Pensacola, Florida, 32503

  • Mid Atlantic Retina

    Philadelphia, Pennsylvania, 19107

  • Retinal Research Institute, LLC

    Phoenix, Arizona, 85014

  • Associated Retina Consultants, Ltd.

    Phoenix, Arizona, 85020

  • Arizona Retina and Vitreous Consultants

    Phoenix, Arizona, 85021

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Retina Institute of Virginia

    Richmond, Virginia, 23235

  • Retina Associates of Western New York

    Rochester, New York, 14620

  • Retina Associates of Utah

    Salt Lake City, Utah, 84107

  • San Antonio Eye Center

    San Antonio, Texas, 78215

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240

  • Retinal Consultants of San Antonio

    San Antonio, Texas, 78240

  • Thomas Eye Group, PC

    Sandy Springs, Georgia, 30328

  • Orange County Retina Medical Group

    Santa Ana, California, 92705

  • California Retina Consultants

    Santa Barbara, California, 93103

  • Island Retina

    Shirley, New York, 11967

  • Retina Eye Specialists

    South Pasadena, California, 91030

  • Carolina Eye Associates

    Southern Pines, North Carolina, 28387

  • Retina Vitreous Associates of Florida - Saint Petersburg

    St. Petersburg, Florida, 33711

  • USF Eye Institute

    Tampa, Florida, 33612

  • Retina Associates of New Jersey

    Teaneck, New Jersey, 07666

  • Retina Consultants of Houston

    The Woodlands, Texas, 77384

  • The Bert M Glaser National Retina Institute

    Towson, Maryland, 21204

  • Retina Associates Southwest, P.C.

    Tucson, Arizona, 85710

  • Associates in Ophthalmology, Ltd.

    West Mifflin, Pennsylvania, 15122

  • Wake Forest Baptist Health Eye Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

Spain13 sites

  • Centro de Oftalmologia Barraquer

    Barcelona, 08021

  • Institut Clinic d'Oftalmologia Hospital Clinic de Barcelona

    Barcelona, 08028

  • Instituto de Microcirugía Ocular DOS, S.L.U Area de Consultas

    Barcelona, 08035

  • Hospital Universitario de Bellvitge

    Barcelona, 08907

  • Valles Oftalmologia Research Hospital

    Barcelona, 08915

  • Instituto Clínico Quirúrgico de Oftalmología (ICQO)

    Bilbao, 48006

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Clinica Universidad de Navarra Servicio de Oftalmologia

    Pamplona, 31008

  • Hospital General de Valencia Unidad de Investigacion Clinica

    Valencia, 46014

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

  • Hospital Clinico Universitario

    Valladolid, 47005

  • Hospital Clínico Universitario Lozano Blesa. Unidad de Retina Médica y Quirúrgica

    Zaragoza, 50009

  • Hospital Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Germany10 sites

  • Dardenne Eye Hospital

    Bad Godesberg, 53177

  • Klinikum Dresden Friedrichstadt

    Dresden, 01067

  • Internationale Innovative Ophthalmochirurgie Breyer & Kaymak & Klabe Augenchirurgie

    Düsseldorf, 40212

  • Eye Center, University of Freiburg

    Freiburg im Breisgau, 79106

  • Universitats-augenklinik Gottingen

    Göttingen, 37075

  • Stadtisches Klinikum

    Karlsruhe, 76133

  • Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Augenheilkunde

    Leipzig, 04103

  • Universitätsklinikum Giessen und Marburg GmbH

    Marburg, 35043

  • Augenklinik im Dietrich-Bonhoeffer - Klinikum Neubrandenburg

    Neubrandenburg, 17036

  • Clinic and policlinic of ophthalmology, University of Regensburg

    Regensburg, 93053

Other trials in Germany

Israel10 sites

  • Bnai Zion Medical Center (BZMC) Technion-Israel Institute of Technology

    Haifa, 31048

  • Rambam Health Care Campus

    Haifa, 31096

  • Carmel Medical Center Ophthalmology Clinic

    Haifa, 34362

  • Edith Wolfson Medical Center

    Holon, 58100

  • Meir Medical Center

    Kfar Saba, 44281

  • Rabin Medical Center Beilinson Hospital

    Petah Tikva, 49100

  • Kaplan Medical Center

    Rehovot, 76100

  • TASMC (The Tel-Aviv Sourasky Medical Centre)

    Tel Aviv, 64239

  • Chaim Sheba Medical Center Goldschleger Eye Clinic Sheba Medical Center

    Tel HaShomer, 52621

  • Shamir Medical Centre

    Tsrifin, 70300

Other trials in Israel

Argentina9 sites

  • Organizacion Medica de Investigacion

    Buenos Aires, C1015ABO

  • Instituto Oftalmologico de Buenos Aires - Oftalmos

    Buenos Aires, C1120AAN

  • Centro Privado de Ojos Romagosa

    Córdoba, X5000AAJ

  • Instituto Oftalmologico de Cordoba

    Córdoba, X5000IIT

  • Clinica Privada Kaufer Cataract Center

    Martínez, Buenos Aires, B1640BNT

  • Oftar Centro Privado de Oftalmologia

    Mendoza, M5500GGK

  • Hospital Universitario Austral

    Pilar, Buenos Aires, B1629ODT

  • Centro Oftalmologico Rosario SRL

    Rosario, Santa Fe Province, S2000ANJ

  • Grupo Laser Vision

    Rosario, Santa Fe Province, S2000AZH

Other trials in Argentina

France6 sites

  • Hopital Pellegrin

    Bordeaux, 33076

  • Centre Hospitalier Intercommunal de Creteil

    Créteil, 94010

  • Hopital de la Croix Rousse, Service d'Opthalmologie

    Lyon, 69417

  • CHU de Nantes

    Nantes, 44093

  • Centre Ophtalmologique d'Imagerie et de Laser

    Paris, 75015

  • Centre Ophtalmologique Saint Exupery

    Saint-Cyr-sur-Loire, 37540

Other trials in France

Philippines5 sites

  • Cebu Doctors University Hospital

    Cebu City, National Capital Region, 6000

  • Asian Eye Institute

    Makati City, National Capital Region, 1200

  • Pacific Eyecare and Laser Institute

    Makati City, National Capital Region, 1209

  • The Medical City

    Pasig, National Capital Region, 1600

  • St. Luke's Medical Center

    Quezon City, National Capital Region, 1102

Other trials in Philippines

South Korea5 sites

  • The Catholic Univ. Of Seoul St. Mary's Hospital

    Seocho, Seoul, 137-701

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 463-707

  • Asan Medical Center

    Seoul, 05505

  • Seoul National University Hospital

    Seoul, 110-744

  • Yonsei University Health System Serverance Hospital

    Seoul, 120-752

Other trials in South Korea

Austria4 sites

  • Medical University Graz

    Graz, 8036

  • Medizinische Universitat Innsbruck, Univ.

    Innsbruck, 6020

  • Kepler Universitatsklinikum GmBH

    Linz, 4020

  • Konventhospital Barmherzige Brueder Linz

    Linz, 4021

Other trials in Austria

Czechia4 sites

  • Fakultni nemocnice Brno

    Brno, 62500

  • Fakultni nemocnice Olomouc

    Olomouc, 77900

  • Fakultni nemocnice Kralovske Vinohrady Oftalmologicka klinika

    Prague, 100 34

  • Vseobecna fakultni nemocnice v Praze Ocni Klinika

    Prague, 128 00

Other trials in Czechia

Switzerland3 sites

  • Universitatsklinik fur Augenheilkunde, Inselspital

    Bern, 3010

  • VISTA Klinik Binningen

    Binningen, 4102

  • Stiftung für wissenschaftliche Forschung am Stadtspital Triemli

    Zurich, 8063

Other trials in Switzerland

Chile2 sites

  • KYDOFT

    Santiago, Las Condes, 7560994

  • Instituto Oftalmologica Profesor Arentsen

    Santiago, Santiago Metropolitan, 7510168

Other trials in Chile

Colombia2 sites

  • Fundacion Oftalmologica Nacional - FUNDONAL

    Bogotá

  • Centro Medico Imbanaco

    Cali, Valle del Cauca Department, 760042

Other trials in Colombia

Hong Kong2 sites

  • The University of Hong Kong

    Aberdeen

  • The Chinese University of Hong Kong Hongkong eye hospital

    Kowloon

Other trials in Hong Kong

New Zealand2 sites

  • University of Auckland

    Auckland, 1123

  • Auckland Eye

    Remuera, Auckland, 1051

Other trials in New Zealand

Singapore2 sites

  • National University Hospital

    Singapore, 119228

  • Singapore National Eye Centre- Singapore Eye Research Institute (SNECSERI)

    Singapore, 168751

Other trials in Singapore

Latvia1 site

  • Pauls Stradins Clinical University Hospital Opthalmology Clinic

    Riga, LV, LV-1002

Other trials in Latvia

About this study

Official title: 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.

Being tested
Abicipar Pegol, Ranibizumab, Sham Procedure
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abicipar PegolDrug

    Also called AGN-150998

    Abicipar pegol intravitreal injection.

  • RanibizumabDrug

    Also called Lucentis®

    Ranibizumab intravitreal injection.

  • Sham ProcedureOther

    Sham injection.

Study groups in NCT02462928
Study groupRoleWhat they receive
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.
Receives: Drug: Abicipar Pegol; Other: Sham Procedure
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.
Receives: Drug: Abicipar Pegol; Other: Sham Procedure
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.
Receives: Drug: Ranibizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to Week 52

Secondary outcomes (4)

  1. Mean Change From Baseline in BCVA in the Study Eye at 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.

    Measured: Baseline to Week 52

  2. Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at 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.

    Measured: Baseline to Week 52

  3. Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in Study Eye at 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.

    Measured: Baseline to Week 52

  4. Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score in Study Eye at 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.

    Measured: Baseline to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2015 (estimated)
  2. Study start25 Jun 2015
  3. Primary completion18 Apr 2018
  4. Study completion19 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
939 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02462928
Sponsor's protocol ID
150998-005
Other IDs
2014-004579-22, CEDAR, 2014
Acronym
CEDAR
Status last verified
Jul 2020
First submitted
2 Jun 2015
Last updated
28 Jul 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abicipar Pegol and Ranibizumab in people with Macular Degeneration, run by Allergan at 151 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 151 sites in United States, Spain, Germany, Israel, Argentina and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Stable Vision at Week 52 (time frame: Baseline to Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02462928.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.

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