Clinical trial NCT02462486: Safety and Efficacy 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 (SEQUOIA Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Macular Degeneration
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2015-06-04
Enrollment: 949
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 Best-corrected Visual Acuity (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 BCVA Gain of More Than 15 Letters From Baseline in the 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 at Week 52
timeFrame: Baseline to Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Eye Foundation Hospital
state: Alabama
city: Gilbert
country: United States
facility: Retinal Consultants of Arizona
state: Arizona
city: Phoenix
country: United States
facility: Barnet Dulaney Perkins Eye Center - Phoenix
state: Arizona
city: Tucson
country: United States
facility: Retina Centers, PC
state: Arizona
city: Springdale
country: United States
facility: Northwest Arkansas Retina Associates
state: Arkansas
city: Arcadia
country: United States
facility: Win Retina
state: California
city: Arcadia
country: United States
facility: Retina Institute of California
state: California
city: Campbell
country: United States
facility: Retinal Diagnostic Center
state: California
city: Glendale
country: United States
facility: Specialty Eye Care Medical Center, Inc.
state: California
city: Irvine
country: United States
facility: University of California at Irvine Gavin Herbert Eye Institute
state: California
city: Laguna Hills
country: United States
facility: Retina Associates of Orange County
state: California
city: Long Beach
country: United States
facility: South Coast Retina Center
state: California
city: Oakland
country: United States
facility: East Bay Retina Consultants, Inc.
state: California
city: Oceanside
country: United States
facility: San Diego Retina Associates
state: California
city: Palm Desert
country: United States
facility: Southern California Desert Retina Consultants
state: California
city: Pasadena
country: United States
facility: California Eye Specialist Medical Group
state: California
city: Poway
country: United States
facility: Retina Consultants, San Diego
state: California
city: Redlands
country: United States
facility: Retina Consultants of Southern California
state: California
city: Riverside
country: United States
facility: Kaiser Permanente Riverside Medical Center
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center, Department of Ophthalmology
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group, Inc.
state: California
city: San Francisco
country: United States
facility: West Coast Retina Medical Group
state: California
city: San Francisco
country: United States
facility: Pacific Eye Associates
state: California
city: Bradenton
country: United States
facility: The Eye Associates
state: Florida
city: Fort Myers
country: United States
facility: National Ophthalmic Research Institute
state: Florida
city: Miami
country: United States
facility: Retina Macula Specialists of Miami
state: Florida
city: Miami
country: United States
facility: MedEye Associates
state: Florida
city: Plantation
country: United States
facility: Fort Lauderdale Eye Institute
state: Florida
city: Sarasota
country: United States
facility: Sarasota Retina Institute
state: Florida
city: Stuart
country: United States
facility: East Florida Eye Institute
state: Florida
city: Tampa
country: United States
facility: Retina Associate of Florida, P.A.
state: Florida
city: Tampa
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina and Macular Disease
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Downers Grove
country: United States
facility: DuPage Medical Group
state: Illinois
city: Elmhurst
country: United States
facility: Kovach Eye Institute
state: Illinois
city: Oak Forest
country: United States
facility: University Retina and Macula Associates
state: Illinois
city: Wheaton
country: United States
facility: Wheaton Eye Clinic, Clinical Research Center, LLC
state: Illinois
city: Leawood
country: United States
facility: Sabates Eye Centers
state: Kansas
city: Paducah
country: United States
facility: Paducah Retinal Center
state: Kentucky
city: Baltimore
country: United States
facility: The Retina Care Center
state: Maryland
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants, P.C.
state: Maryland
city: Worcester
country: United States
facility: Vitreo-Retinal Associates, Pc
state: Massachusetts
city: Grand Rapids
country: United States
facility: Retina Specialists of Michigan
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Bloomfield
country: United States
facility: Retina Center of New Jersey, LLC
state: New Jersey
city: Lawrenceville
country: United States
facility: Delaware Valley Retina Associates
state: New Jersey
city: Hauppauge
country: United States
facility: Long Island Vitreoretinal Consultants
state: New York
city: New York
country: United States
facility: Maculacare - New York
state: New York
city: Syracuse
country: United States
facility: Retina Vitreous Surgeons of Central NY, PC
state: New York
city: Asheville
country: United States
facility: Western Carolina Retinal Associates, PA
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Eye Ear Nose & Throat Associates, PA
state: North Carolina
city: Beachwood
country: United States
facility: Retina Associates of Cleveland, Inc
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Dublin
country: United States
facility: Midwest Retina, Inc.
state: Ohio
city: Ashland
country: United States
facility: Retina & Vitreous Center SO, PC
state: Oregon
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Camp Hill
country: United States
facility: Pennsylvania Retina Specialists, P.C.
state: Pennsylvania
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Beaumont
country: United States
facility: Retina and Vitreous of Texas
state: Texas
city: Galveston
country: United States
facility: The University of Texas Medical Branch
state: Texas
city: Midland
country: United States
facility: Premiere Retina Specialists
state: Texas
city: San Antonio
country: United States
facility: Retina Associates of South Texas, PA
state: Texas
city: Willow Park
country: United States
facility: Strategic Clinical Research Group, LLC
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah, John Moran Eye Center
state: Utah
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
city: Virginia Beach
country: United States
facility: Wagner Macula and Retina Center
state: Virginia
city: Bellevue
country: United States
facility: Vitreoretinal Associates of Washington
state: Washington
city: Spokane
country: United States
facility: Spokane Eye Clinical Research
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Eye Institute
state: West Virginia
city: Sydney
country: Australia
facility: Save Sight Institute, University of Sydney Eye Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Retina Clinic and Day Surgery
state: New South Wales
city: Westmead
country: Australia
facility: Sydney West Retina
state: New South Wales
city: East Melbourne
country: Australia
facility: Centre for Eye Research Australia
state: Victoria
city: Glen Waverley
country: Australia
facility: Specialist Eye Group
state: Victoria
city: Nedlands
country: Australia
facility: Lions Eye Institute
state: Western Australia
city: Goiania
country: Brazil
facility: Centro Brasileiro de Cirurgia de Olhos - CBCO
state: Goias
city: Belo Horizonte
country: Brazil
facility: Instistuto da Visao - Hospital de Olhos Ltda
state: Minas Gerais
city: Sorocaba
country: Brazil
facility: Hospital Oftalmologico de Sorocaba
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Clinica de Olhos Dr. Suel Abujamra
city: Sao Paulo
country: Brazil
facility: Instituto Da Visao UNIFESP EPM (Universidade Federal de Sao Paulo - Escola Paulista de Medicina)
city: Calgary
country: Canada
facility: Calgary Retina Consultants
state: Alberta
city: London
country: Canada
facility: St Joseph's Health Care London - Ivey Eye Institute
state: Ontario
city: Mississauga
country: Canada
facility: Canadian Centre for Advanced Eye Therapeutics Inc
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Eye Institute
state: Ontario
city: Toronto
country: Canada
facility: Toronto Retina Institute
state: Ontario
city: Glostrup
country: Denmark
facility: Rigshospitalet-Glostrup
state: Hovedstaden
city: Odense
country: Denmark
facility: Odense University Hospital
state: Syddanmark
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszegugyi Kozpont
city: Budapest
country: Hungary
facility: Semmelweis University
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Hospital
city: Budapest
country: Hungary
facility: Szent Imre Teaching Hospital
city: Budapest
country: Hungary
facility: Budapest Retina Associates Kft.
city: Debrecen
country: Hungary
facility: University of Debrecen, Medical Center
city: Pecs
country: Hungary
facility: Ganglion Medical Centre
city: Szeged
country: Hungary
facility: University of Szeged
city: Szombathely
country: Hungary
facility: Markusovszki Teaching Hospital
city: Chieti
country: Italy
facility: Ospedale Clinicizzato
state: Abruzzi
city: Udine
country: Italy
facility: Clinica Oculistica, Ospedale Santa Maria della Misericordia
state: Friuli-Venezia Giulia
city: Milan
country: Italy
facility: Eye Clinic - Fondazione IRCCS
state: Lombardy
city: Milan
country: Italy
facility: Clinica Oculistica- Dipartimento di Scienze Cliniche Universita di Milano
state: Lombardy
city: Torino
country: Italy
facility: Ospedale Molinette
state: Piedmont
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi - SOD Oculistica, Dipartimento di Chirurgia e Medicina Traslazionale
state: Tuscany
city: Pisa
country: Italy
facility: Azienda Universitaria Ospedaliera Pisana, Ospedale "Nuovo S.Chiara" Cisanello
state: Tuscany
city: Verona
country: Italy
facility: IRCCS - Istuto di Recovero e Cura a Carattere Scientifico
state: Vento
city: Bologna
country: Italy
facility: A.O.U. Policlinico Sant Orsola Malpighi Pad1, 4Piano, Studio Medici via Pelagio Palagi 9
city: Genova
country: Italy
facility: Clinica Oculistica DINOGMI Universita di Genova
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Roma
country: Italy
facility: Policlinico Agostino Gemelli
city: Roma
country: Italy
facility: Fondazione G.B. Bietti-IRCCS
city: Nagakute
country: Japan
facility: Aichi Medical University Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Japan Community Health Care Organization Chukyo Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Kamogawa
country: Japan
facility: Kameda Clinic
state: Chiba
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center
state: Chiba
city: Urayasu
country: Japan
facility: Juntendo University Urayasu Hospital
state: Chiba
city: Ogaki
country: Japan
facility: Ogaki Tokushukai Hospital
state: Gifu
city: Kure
country: Japan
facility: Kimura Eye And Internal Medicine Hospital
state: Hiroshima
city: Sapporo
country: Japan
facility: Sapporo City General Hospital
state: Hokkaido
city: Amagasaki
country: Japan
facility: Hyogo Prefectural Amagasaki Hospital General Medical Center
state: Hyogo
city: Inashiki
country: Japan
facility: Tokyo Medical University Ibaraki Medical Center
state: Ibaraki
city: Mito
country: Japan
facility: Mito Kyodo General Hospital
state: Ibaraki
city: Yamato
country: Japan
facility: Otakeganka Tsukimino Clinic
state: Kanagawa
city: Kanagawa
country: Japan
facility: Kikuna Yuda Eye Clinic
state: Kanto
city: Tsu
country: Japan
facility: Mie University Hospital
state: Mie
city: Iida
country: Japan
facility: Iida Municipal Hospital
state: Nagano
city: Otsu
country: Japan
facility: Shiga University of Medical Science Hospital
state: Shiga
city: Hamamatsu
country: Japan
facility: Seirei Hamamatsu General Hospital
state: Shizuoka
city: Chiyoda
country: Japan
facility: Nihon University Hospital
state: Tokyo
city: Chofu
country: Japan
facility: Chofu Eye Clinic
state: Tokyo
city: Hachioji
country: Japan
facility: Tokyo Medical University Hachioji Medical Center
state: Tokyo
city: Taito
country: Japan
facility: Takeuchi Eye Clinic
state: Tokyo
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Kitakyushu
country: Japan
facility: Kokura Kinen Hospital
city: Kumamoto
country: Japan
facility: Ideta Eye Hospital
city: Nagasaki
country: Japan
facility: The Japanese Red Cross Nagasaki Genbaku Hospital
city: Nara
country: Japan
facility: Nara Medical University Hospital
city: Osaka
country: Japan
facility: Medical Corporation Jinshikai Nishi Eye Hospital
city: Osaka
country: Japan
facility: Musashi Dream Clinic
city: Osaka
country: Japan
facility: Tane Memorial Eye Hospital
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University Hospital
city: Tilburg
country: Netherlands
facility: Elisabeth Hospital
state: North Brabant
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: North Holland
city: Rotterdam
country: Netherlands
facility: Oogziekenhuis Rotterdam
state: North Holland
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: South Holland
city: San Isidro
country: Peru
facility: Macula D&T Eye Center
state: Lima
city: Gdansk
country: Poland
facility: Optimum Profesorskie Centrum Okulistyki
city: Lodz
country: Poland
facility: Klinika Okulistyczna Jasne Blonia
city: Olsztyn
country: Poland
facility: Centrum Diagnostyki i Mikrochirurgii
city: Warsaw
country: Poland
facility: Retina Eye Hospital
city: Wrocław
country: Poland
facility: Uniwersytecki Szpital Kliniczny
city: Moscow
country: Russian Federation
facility: Scientific Research Institute of Ocular Diseases of RAMS
city: Moscow
country: Russian Federation
facility: S. Fyodorov Eye Microsurgery Federal State Institution
city: Bloemfontein
country: South Africa
facility: Pasteur Medical Centre
city: Cape Town
country: South Africa
facility: Dr Actons Privat Practice
city: Pretoria
country: South Africa
facility: Pretoria Eye Institute, Private Practice
city: Kaohsiung
country: Taiwan
facility: Department of Ophthalmology Kaohsiung Veterans General Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taipei
country: Taiwan
facility: Department of Ophthalmology National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation, Linkou Branch
city: Ankara
country: Turkey
facility: Ankara Uni Med Fac
city: Izmir
country: Turkey
facility: Dokuz Eylul Uni Med Fac
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital
state: Camberley
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
state: Derbyshire
city: Colchester
country: United Kingdom
facility: ESNEFT Essex County Hospital
state: Essex
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
state: Hampshire
city: Oxford
country: United Kingdom
facility: Oxford Eye Hospital, John Radcliffe Hospital
state: Headington
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
state: North West England
city: Guildford
country: United Kingdom
facility: Royal Surrey Hospital
state: South East
city: Sutton Coldfield
country: United Kingdom
facility: Heart of England NHS Foundation Trust, Good Hope Hospital
state: Staffordshire
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
state: Wales
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary (BRI)
state: West Yorkshire
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals
state: Yorkshire
city: Barnet
country: United Kingdom
facility: Barnet Hospital
city: Bristol
country: United Kingdom
facility: Bristol Eye Hospital
city: Liverpool
country: United Kingdom
facility: University Hospital Aintree
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
city: London
country: United Kingdom
facility: Barnet Royal Free Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: Newcastle
country: United Kingdom
facility: Royal Victoria Infirmary
city: Rugby
country: United Kingdom
facility: Hospital of St. Cross
city: Sunderland
country: United Kingdom
facility: City Hospitals Sunderland NHS
Study officials:
affiliation: Allergan
name: Joanne Li
role: STUDY_DIRECTOR
References: