Safety and Efficacy of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration
3 other identifiers
interventional
949
16 countries
187
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
187 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 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 6, 2019
CompletedResults Posted
Study results publicly available
July 30, 2020
CompletedJuly 30, 2020
July 1, 2020
2.8 years
June 2, 2015
July 17, 2020
July 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Stable Vision at Week 52
Stable vision was defined as vision loss of fewer than 15 letters in Best-corrected Visual Acuity (BCVA) from baseline. BCVA is measured using an eye chart and is 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 percentage of participants with a BCVA loss of fewer than 15 letters are reported. Study eye was defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.
Baseline to Week 52
Secondary Outcomes (4)
Mean Change From Baseline in Best-corrected Visual Acuity (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 BCVA Gain of More Than 15 Letters From Baseline in the 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 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, and Week 8, followed by injections every 8 weeks 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, and Week 12, followed by injections every 12 weeks 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 (rQ4)
ACTIVE COMPARATORRanibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks 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 (187)
Eye Foundation Hospital
Birmingham, Alabama, 35233, United States
Retinal Consultants of Arizona
Gilbert, Arizona, 85296, United States
Barnet Dulaney Perkins Eye Center - Phoenix
Phoenix, Arizona, 85016-4701, United States
Retina Centers, PC
Tucson, Arizona, 85704, United States
Northwest Arkansas Retina Associates
Springdale, Arkansas, 72762, United States
Win Retina
Arcadia, California, 91006, United States
Retina Institute of California
Arcadia, California, 91007, United States
Retinal Diagnostic Center
Campbell, California, 95008, United States
Specialty Eye Care Medical Center, Inc.
Glendale, California, 91203, United States
University of California at Irvine Gavin Herbert Eye Institute
Irvine, California, 92697-4375, United States
Retina Associates of Orange County
Laguna Hills, California, 92653, United States
South Coast Retina Center
Long Beach, California, 90807, United States
East Bay Retina Consultants, Inc.
Oakland, California, 94609, United States
San Diego Retina Associates
Oceanside, California, 92056, United States
Southern California Desert Retina Consultants
Palm Desert, California, 92211, United States
California Eye Specialist Medical Group
Pasadena, California, 91107, United States
Retina Consultants, San Diego
Poway, California, 92064, United States
Retina Consultants of Southern California
Redlands, California, 92374, United States
Kaiser Permanente Riverside Medical Center
Riverside, California, 92505, United States
UC Davis Medical Center, Department of Ophthalmology
Sacramento, California, 95817, United States
Retinal Consultants Medical Group, Inc.
Sacramento, California, 95841, United States
West Coast Retina Medical Group
San Francisco, California, 94109, United States
Pacific Eye Associates
San Francisco, California, 94115, United States
The Eye Associates
Bradenton, Florida, 34209, United States
National Ophthalmic Research Institute
Fort Myers, Florida, 33912, United States
Retina Macula Specialists of Miami
Miami, Florida, 33126, United States
MedEye Associates
Miami, Florida, 33143, United States
Fort Lauderdale Eye Institute
Plantation, Florida, 33324, United States
Sarasota Retina Institute
Sarasota, Florida, 34239, United States
East Florida Eye Institute
Stuart, Florida, 34994, United States
Retina Associate of Florida, P.A.
Tampa, Florida, 33609, United States
Retina Vitreous Associates of Florida
Tampa, Florida, 33617, United States
Center for Retina and Macular Disease
Winter Haven, Florida, 33880, United States
Southeast Retina Center
Augusta, Georgia, 30909, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
DuPage Medical Group
Downers Grove, Illinois, 60515, United States
Kovach Eye Institute
Elmhurst, Illinois, 60126, United States
University Retina and Macula Associates
Oak Forest, Illinois, 60452, United States
Wheaton Eye Clinic, Clinical Research Center, LLC
Wheaton, Illinois, 60187, United States
Sabates Eye Centers
Leawood, Kansas, 66211, United States
Paducah Retinal Center
Paducah, Kentucky, 42001, United States
The Retina Care Center
Baltimore, Maryland, 21209, United States
Cumberland Valley Retina Consultants, P.C.
Hagerstown, Maryland, 21740, United States
Vitreo-Retinal Associates, Pc
Worcester, Massachusetts, 01605, United States
Retina Specialists of Michigan
Grand Rapids, Michigan, 49546, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Retina Center of New Jersey, LLC
Bloomfield, New Jersey, 07003, United States
Delaware Valley Retina Associates
Lawrenceville, New Jersey, 08648, United States
Long Island Vitreoretinal Consultants
Hauppauge, New York, 11788, United States
Maculacare - New York
New York, New York, 10021, United States
Retina Vitreous Surgeons of Central NY, PC
Syracuse, New York, 13224, United States
Western Carolina Retinal Associates, PA
Asheville, North Carolina, 28803, United States
Charlotte Eye Ear Nose & Throat Associates, PA
Charlotte, North Carolina, 28210, United States
Retina Associates of Cleveland, Inc
Beachwood, Ohio, 44122, United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242-5664, United States
Ohio State University
Columbus, Ohio, 43212, United States
Midwest Retina, Inc.
Dublin, Ohio, 43016, United States
Retina & Vitreous Center SO, PC
Ashland, Oregon, 97520, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
Pennsylvania Retina Specialists, P.C.
Camp Hill, Pennsylvania, 17011, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701, United States
Austin Retina Associates
Austin, Texas, 78705, United States
Retina and Vitreous of Texas
Beaumont, Texas, 77707, United States
The University of Texas Medical Branch
Galveston, Texas, 77550, United States
Premiere Retina Specialists
Midland, Texas, 79706, United States
Retina Associates of South Texas, PA
San Antonio, Texas, 78240, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, 76087, United States
University of Utah, John Moran Eye Center
Salt Lake City, Utah, 84132, United States
Virginia Eye Consultants
Norfolk, Virginia, 23502, United States
Wagner Macula and Retina Center
Virginia Beach, Virginia, 23454, United States
Vitreoretinal Associates of Washington
Bellevue, Washington, 98004, United States
Spokane Eye Clinical Research
Spokane, Washington, 99204, United States
West Virginia University Eye Institute
Morgantown, West Virginia, 26506, United States
Save Sight Institute, University of Sydney Eye Hospital
Sydney, New South Wales, 2000, Australia
Sydney Retina Clinic and Day Surgery
Sydney, New South Wales, 2000, Australia
Sydney West Retina
Westmead, New South Wales, 2145, Australia
Centre for Eye Research Australia
East Melbourne, Victoria, 3002, Australia
Specialist Eye Group
Glen Waverley, Victoria, 3150, Australia
Lions Eye Institute
Nedlands, Western Australia, 6009, Australia
Centro Brasileiro de Cirurgia de Olhos - CBCO
Goiânia, Goiás, 74210-010, Brazil
Instistuto da Visao - Hospital de Olhos Ltda
Belo Horizonte, Minas Gerais, 30330-000, Brazil
Hospital Oftalmologico de Sorocaba
Sorocaba, São Paulo, 18031-060, Brazil
Clinica de Olhos Dr. Suel Abujamra
São Paulo, 01525-001, Brazil
Instituto Da Visao UNIFESP EPM (Universidade Federal de Sao Paulo - Escola Paulista de Medicina)
São Paulo, 04023-062, Brazil
Calgary Retina Consultants
Calgary, Alberta, T2H 0C8, Canada
St Joseph's Health Care London - Ivey Eye Institute
London, Ontario, N6A 4V2, Canada
Canadian Centre for Advanced Eye Therapeutics Inc
Mississauga, Ontario, L4W 1W9, Canada
University of Ottawa Eye Institute
Ottawa, Ontario, K1H 8L6, Canada
Toronto Retina Institute
Toronto, Ontario, M3C0G9, Canada
Rigshospitalet-Glostrup
Glostrup Municipality, Capital Region, 2600, Denmark
Odense University Hospital
Odense, Region Syddanmark, C 5000, Denmark
Magyar Honvedseg Egeszegugyi Kozpont
Budapest, 1068, Hungary
Semmelweis University
Budapest, 1085, Hungary
Bajcsy-Zsilinszky Hospital
Budapest, 1106, Hungary
Szent Imre Teaching Hospital
Budapest, 1115, Hungary
Budapest Retina Associates Kft.
Budapest, 1133, Hungary
University of Debrecen, Medical Center
Debrecen, 4032, Hungary
Ganglion Medical Centre
Pécs, 7621, Hungary
University of Szeged
Szeged, 6720, Hungary
Markusovszki Teaching Hospital
Szombathely, 9700, Hungary
Ospedale Clinicizzato
Chieti, Abruzzo, 66100, Italy
Clinica Oculistica, Ospedale Santa Maria della Misericordia
Udine, Friuli Venezia Giulia, 33100, Italy
Eye Clinic - Fondazione IRCCS
Milan, Lombardy, 20122, Italy
Clinica Oculistica- Dipartimento di Scienze Cliniche Universita di Milano
Milan, Lombardy, 20157, Italy
Ospedale Molinette
Turin, Piedmont, 10126, Italy
Azienda Ospedaliero-Universitaria Careggi - SOD Oculistica, Dipartimento di Chirurgia e Medicina Traslazionale
Florence, Tuscany, 50134, Italy
Azienda Universitaria Ospedaliera Pisana, Ospedale "Nuovo S.Chiara" Cisanello
Pisa, Tuscany, 56124, Italy
IRCCS - Istuto di Recovero e Cura a Carattere Scientifico
Verona, Vento, 37024, Italy
A.O.U. Policlinico Sant Orsola Malpighi Pad1, 4Piano, Studio Medici via Pelagio Palagi 9
Bologna, 40138, Italy
Clinica Oculistica DINOGMI Universita di Genova
Genova, 16132, Italy
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
Policlinico Agostino Gemelli
Roma, 00168, Italy
Fondazione G.B. Bietti-IRCCS
Roma, 00198, Italy
Aichi Medical University Hospital
Nagakute, Aichi-ken, 480-1195, Japan
Japan Community Health Care Organization Chukyo Hospital
Nagoya, Aichi-ken, 457-8510, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560, Japan
Kameda Clinic
Kamogawa, Chiba, 296-0041, Japan
Toho University Sakura Medical Center
Sakura, Chiba, 285-8741, Japan
Juntendo University Urayasu Hospital
Urayasu, Chiba, 279-0021, Japan
Ogaki Tokushukai Hospital
Ōgaki, Gifu, 503-0015, Japan
Kimura Eye And Internal Medicine Hospital
Kure, Hiroshima, 737-0029, Japan
Sapporo City General Hospital
Sapporo, Hokkaido, 060-8604, Japan
Hyogo Prefectural Amagasaki Hospital General Medical Center
Amagasaki, Hyōgo, 660-8550, Japan
Tokyo Medical University Ibaraki Medical Center
Inashiki, Ibaraki, 300-0395, Japan
Mito Kyodo General Hospital
Mito, Ibaraki, 310-0015, Japan
Otakeganka Tsukimino Clinic
Yamato, Kanagawa, 242-0001, Japan
Kikuna Yuda Eye Clinic
Kanagawa, Kanto, 222-0011, Japan
Mie University Hospital
Tsu, Mie-ken, 514-8507, Japan
Iida Municipal Hospital
Iida, Nagano, 395-8502, Japan
Shiga University of Medical Science Hospital
Ōtsu, Shiga, 520-2192, Japan
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, 430-8558, Japan
Nihon University Hospital
Chiyoda City, Tokyo, 101-8309, Japan
Chofu Eye Clinic
Chōfu, Tokyo, 182-0024, Japan
Tokyo Medical University Hachioji Medical Center
Hachiōji, Tokyo, 193-0998, Japan
Takeuchi Eye Clinic
Taitō City, Tokyo, 111-0051, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Fukushima Medical University Hospital
Fukushima, 960-1295, Japan
Kokura Kinen Hospital
Kitakyushu, 802-8555, Japan
Ideta Eye Hospital
Kumamoto, 860-0027, Japan
The Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki, 852-0851, Japan
Nara Medical University Hospital
Nara, 634-8522, Japan
Medical Corporation Jinshikai Nishi Eye Hospital
Osaka, 537-0025, Japan
Musashi Dream Clinic
Osaka, 543-0027, Japan
Tane Memorial Eye Hospital
Osaka, 550-0024, Japan
Tokyo Women's Medical University Hospital
Tokyo, 162-8666, Japan
Elisabeth Hospital
Tilburg, North Brabant, 5022 GC, Netherlands
Academic Medical Center
Amsterdam, North Holland, 1105 AZ, Netherlands
Oogziekenhuis Rotterdam
Rotterdam, North Holland, 3011 BH, Netherlands
Leiden University Medical Center
Leiden, South Holland, 2333 ZA, Netherlands
Macula D&T Eye Center
San Isidro, Lima region, 27, Peru
Optimum Profesorskie Centrum Okulistyki
Gdansk, 80-809, Poland
Klinika Okulistyczna Jasne Blonia
Lodz, 91-134, Poland
Centrum Diagnostyki i Mikrochirurgii
Olsztyn, 10-424, Poland
Retina Eye Hospital
Warsaw, 01-364, Poland
Uniwersytecki Szpital Kliniczny
Wroclaw, 50-556, Poland
Scientific Research Institute of Ocular Diseases of RAMS
Moscow, 119021, Russia
S. Fyodorov Eye Microsurgery Federal State Institution
Moscow, 127486, Russia
Pasteur Medical Centre
Bloemfontein, 9301, South Africa
Dr Actons Privat Practice
Cape Town, 7530, South Africa
Pretoria Eye Institute, Private Practice
Pretoria, 0007, South Africa
Department of Ophthalmology Kaohsiung Veterans General Hospital
Kaohsiung City, 813, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833, Taiwan
Department of Ophthalmology National Taiwan University Hospital
Taipei, 100, Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 111, Taiwan
Chang Gung Medical Foundation, Linkou Branch
Taoyuan District, 333, Taiwan
Ankara Uni Med Fac
Ankara, 06590, Turkey (Türkiye)
Dokuz Eylul Uni Med Fac
Izmir, 35340, Turkey (Türkiye)
Frimley Park Hospital
Frimley, Camberley, GU17 7UJ, United Kingdom
Royal Derby Hospital
Derby, Derbyshire, DE22 3NE, United Kingdom
ESNEFT Essex County Hospital
Colchester, Essex, CO4 5JR, United Kingdom
University Hospital Southampton
Southampton, Hampshire, SO16 6YD, United Kingdom
Oxford Eye Hospital, John Radcliffe Hospital
Oxford, Headington, OX3 9DU, United Kingdom
Royal Liverpool University Hospital
Liverpool, North West England, L7 8XP, United Kingdom
Royal Surrey Hospital
Guildford, South East, S10 2TB, United Kingdom
Heart of England NHS Foundation Trust, Good Hope Hospital
Sutton Coldfield, Staffordshire, B75 7RR, United Kingdom
University Hospital of Wales
Cardiff, Wales, CF4 4XW, United Kingdom
Bradford Royal Infirmary (BRI)
Bradford, West Yorkshire, BD18 4JN, United Kingdom
Sheffield Teaching Hospitals
Sheffield, Yorkshire, S10 2TB, United Kingdom
Barnet Hospital
Barnet, EN5 3DJ, United Kingdom
Bristol Eye Hospital
Bristol, BS1 2LX, United Kingdom
University Hospital Aintree
Liverpool, L9 7AL, United Kingdom
Moorfields Eye Hospital
London, EC1V 2PD, United Kingdom
Barnet Royal Free Hospital
London, EN53DJ, United Kingdom
King's College Hospital
London, SE5 9RJ, United Kingdom
Royal Victoria Infirmary
Newcastle, NE1 4LP, United Kingdom
Hospital of St. Cross
Rugby, CV22 5PX, United Kingdom
City Hospitals Sunderland NHS
Sunderland, SR2 9HP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trials Registry Team
- Organization
- Allergan, Inc
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
- TRIPLE
- Who Masked
- PARTICIPANT, 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 12, 2018
Study Completion
June 6, 2019
Last Updated
July 30, 2020
Results First Posted
July 30, 2020
Record last verified: 2020-07