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

Macular Degeneration Clinical Trial

— CEDAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02462928
• Other study ID #: 150998-005
• Secondary ID: 2014-004579-22CE
• Status: Completed
• Phase: Phase 3
• Start date: June 25, 2015
• Est. completion date: June 19, 2019

Study information

• Verified date: July 2020
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 939
• Est. completion date: June 19, 2019
• Est. primary completion date: April 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Drug:
• Abicipar Pegol
Abicipar pegol intravitreal injection.
• Ranibizumab
Ranibizumab intravitreal injection.

Other:
• Sham Procedure
Sham injection.

Locations

Country	Name	City	State
Argentina	Instituto Oftalmologico de Buenos Aires - Oftalmos	Buenos Aires
Argentina	Organizacion Medica de Investigacion	Buenos Aires
Argentina	Centro Privado de Ojos Romagosa	Cordoba
Argentina	Instituto Oftalmologico de Cordoba	Cordoba
Argentina	Clinica Privada Kaufer Cataract Center	Martinez	Buenos Aires
Argentina	Oftar Centro Privado de Oftalmologia	Mendoza
Argentina	Hospital Universitario Austral	Pilar	Buenos Aires
Argentina	Centro Oftalmologico Rosario SRL	Rosario	Santa Fe
Argentina	Grupo Laser Vision	Rosario	Santa Fe
Austria	Medical University Graz	Graz
Austria	Medizinische Universitat Innsbruck, Univ.	Innsbruck
Austria	Kepler Universitatsklinikum GmBH	Linz
Austria	Konventhospital Barmherzige Brueder Linz	Linz
Chile	Instituto Oftalmologica Profesor Arentsen	Santiago	Región Metropolitana
Chile	KYDOFT	Santiago	Las Condes
Colombia	Fundacion Oftalmologica Nacional - FUNDONAL	Bogota
Colombia	Centro Medico Imbanaco	Cali	Valle Del Cauca
Czechia	Fakultni nemocnice Brno	Brno
Czechia	Fakultni nemocnice Olomouc	Olomouc
Czechia	Fakultni nemocnice Kralovske Vinohrady Oftalmologicka klinika	Praha
Czechia	Vseobecna fakultni nemocnice v Praze Ocni Klinika	Praha
France	Hopital Pellegrin	Bordeaux
France	Centre Hospitalier Intercommunal de Creteil	Creteil
France	Hopital de la Croix Rousse, Service d'Opthalmologie	Lyon cedex 04
France	CHU de Nantes	Nantes Cedex 1
France	Centre Ophtalmologique d'Imagerie et de Laser	Paris
France	Centre Ophtalmologique Saint Exupery	Saint Cyr sur Loire
Germany	Dardenne Eye Hospital	Bad Godesberg
Germany	Klinikum Dresden Friedrichstadt	Dresden
Germany	Internationale Innovative Ophthalmochirurgie Breyer & Kaymak & Klabe Augenchirurgie	Dusseldorf
Germany	Eye Center, University of Freiburg	Freiburg
Germany	Universitats-augenklinik Gottingen	Gottingen
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
Hong Kong	The University of Hong Kong	Aberdeen
Hong Kong	The Chinese University of Hong Kong Hongkong eye hospital	Kowloon
Israel	Bnai Zion Medical Center (BZMC) Technion-Israel Institute of Technology	Haifa
Israel	Carmel Medical Center Ophthalmology Clinic	Haifa
Israel	Rambam Health Care Campus	Haifa
Israel	Edith Wolfson Medical Center	Holon
Israel	Meir Medical Center	Kfar-Saba
Israel	Rabin Medical Center Beilinson Hospital	Petach 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 Hashomer
Israel	Shamir Medical Centre	Zerifin
Korea, Republic of	The Catholic Univ. Of Seoul St. Mary's Hospital	Seocho	Seoul
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yonsei University Health System Serverance Hospital	Seoul
Latvia	Pauls Stradins Clinical University Hospital Opthalmology Clinic	Riga	LV
New Zealand	University of Auckland	Auckland
New Zealand	Auckland Eye	Remuera	Auckland
Philippines	Cebu Doctors University Hospital	Cebu City	Metro Manila
Philippines	Asian Eye Institute	Makati City	Metro Manila
Philippines	Pacific Eyecare and Laser Institute	Makati City	Metro Manila
Philippines	The Medical City	Pasig City	Metro Manila
Philippines	St. Luke's Medical Center	Quezon City	Metro Manila
Singapore	National University Hospital	Singapore
Singapore	Singapore National Eye Centre- Singapore Eye Research Institute (SNECSERI)	Singapore
Spain	Centro de Oftalmologia Barraquer	Barcelona
Spain	Hospital Universitario de Bellvitge	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	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
Switzerland	Universitatsklinik fur Augenheilkunde, Inselspital	Bern
Switzerland	VISTA Klinik Binningen	Binningen
Switzerland	Stiftung für wissenschaftliche Forschung am Stadtspital Triemli	Zurich
United States	Retina Consultants of Hawaii, Inc.	'Aiea	Hawaii
United States	Retina Research Institute of Texas	Abilene	Texas
United States	Capital Region Retina, PLLC	Albany	New York
United States	Kellog Eye Center - University of Michigan Health System	Ann Arbor	Michigan
United States	Texas Retina Associates	Arlington	Texas
United States	Texan Eye	Austin	Texas
United States	Retina Specialists	Baltimore	Maryland
United States	Gailey Eye Clinic	Bloomington	Illinois
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	Carle at the Fields	Champaign	Illinois
United States	University of Virginia - Department of Ophthalmology	Charlottesville	Virginia
United States	TX Retina Associates	Dallas	Texas
United States	The Retina Partners	Encino	California
United States	Apex Eye Clinical Research	Fairfield	Ohio
United States	Retina Health Center	Fort Myers	Florida
United States	Retina Consultants of Orange County	Fullerton	California
United States	Mark B. Kislinger MD Inc.	Glendora	California
United States	Colorado Retina Associates	Golden	Colorado
United States	Long Island Vitreoretinal Consultants	Great Neck	New York
United States	Retina Consultants of Carolina	Greenville	South Carolina
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	Atlantis Retina Institute (Atlantis Eyecare)	Huntington Beach	California
United States	Raj K. Maturi, MD, PC	Indianapolis	Indiana
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	Charleston Neuroscience Institute	Ladson	South Carolina
United States	Florida Retina Consultants	Lakeland	Florida
United States	Lancaster Retina Specialists	Lancaster	Pennsylvania
United States	University Retina and Macula Associates, PC	Lemont	Illinois
United States	Loma Linda University Medical Center	Loma Linda	California
United States	Piedmont Eye Center, Inc.	Lynchburg	Virginia
United States	Georgia Retina, P.C.	Marietta	Georgia
United States	Marietta Eye Clinic - Main Office	Marietta	Georgia
United States	University of Minnesota	Minneapolis	Minnesota
United States	Northern California Retina Vitreous Associates Medical Group, INC.	Mountain View	California
United States	John Kenyon American Eye Institute	New Albany	Indiana
United States	Ochsner Health Center	New Orleans	Louisiana
United States	Ocala Eye PA	Ocala	Florida
United States	Ophthalmic Consultants of Long Island	Oceanside	New York
United States	Magruder Eye Institute	Orlando	Florida
United States	Retina Care Specialists	Palm Beach Gardens	Florida
United States	Retina Institute of California	Palm Desert	California
United States	Doheny Vision Research	Pasadena	California
United States	Lahey Medical Center	Peabody	Massachusetts
United States	Retina Specialty Institute	Pensacola	Florida
United States	Mid Atlantic Retina	Philadelphia	Pennsylvania
United States	Arizona Retina and Vitreous Consultants	Phoenix	Arizona
United States	Associated Retina Consultants, Ltd.	Phoenix	Arizona
United States	Retinal Research Institute, LLC	Phoenix	Arizona
United States	Sierra Eye Associates	Reno	Nevada
United States	Retina Institute of Virginia	Richmond	Virginia
United States	Retina Associates of Western New York	Rochester	New York
United States	Retina Vitreous Associates of Florida - Saint Petersburg	Saint Petersburg	Florida
United States	Retina Associates of Utah	Salt Lake City	Utah
United States	Medical Center Ophthalmology Associates	San Antonio	Texas
United States	Retinal Consultants of San Antonio	San Antonio	Texas
United States	San Antonio Eye Center	San Antonio	Texas
United States	Thomas Eye Group, PC	Sandy Springs	Georgia
United States	Orange County Retina Medical Group	Santa Ana	California
United States	California Retina Consultants	Santa Barbara	California
United States	Island Retina	Shirley	New York
United States	Retina Eye Specialists	South Pasadena	California
United States	Carolina Eye Associates	Southern Pines	North Carolina
United States	USF Eye Institute	Tampa	Florida
United States	Retina Associates of New Jersey	Teaneck	New Jersey
United States	Retina Consultants of Houston	The Woodlands	Texas
United States	The Bert M Glaser National Retina Institute	Towson	Maryland
United States	Retina Associates Southwest, P.C.	Tucson	Arizona
United States	Associates in Ophthalmology, Ltd.	West Mifflin	Pennsylvania
United States	Wake Forest Baptist Health Eye Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Chile,  Colombia,  Czechia,  France,  Germany,  Hong Kong,  Israel,  Korea, Republic of,  Latvia,  New Zealand,  Philippines,  Singapore,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline to Week 52
Secondary	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.	Baseline to Week 52
Secondary	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.	Baseline to Week 52
Secondary	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.	Baseline to Week 52