Safety and Efficacy of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration
Macular Degeneration
About this trial
This is an interventional treatment trial for 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
Sites / Locations
- Eye Foundation Hospital
- Retinal Consultants of Arizona
- Barnet Dulaney Perkins Eye Center - Phoenix
- Retina Centers, PC
- Northwest Arkansas Retina Associates
- Win Retina
- Retina Institute of California
- Retinal Diagnostic Center
- Specialty Eye Care Medical Center, Inc.
- University of California at Irvine Gavin Herbert Eye Institute
- Retina Associates of Orange County
- South Coast Retina Center
- East Bay Retina Consultants, Inc.
- San Diego Retina Associates
- Southern California Desert Retina Consultants
- California Eye Specialist Medical Group
- Retina Consultants, San Diego
- Retina Consultants of Southern California
- Kaiser Permanente Riverside Medical Center
- UC Davis Medical Center, Department of Ophthalmology
- Retinal Consultants Medical Group, Inc.
- West Coast Retina Medical Group
- Pacific Eye Associates
- The Eye Associates
- National Ophthalmic Research Institute
- Retina Macula Specialists of Miami
- MedEye Associates
- Fort Lauderdale Eye Institute
- Sarasota Retina Institute
- East Florida Eye Institute
- Retina Associate of Florida, P.A.
- Retina Vitreous Associates of Florida
- Center for Retina and Macular Disease
- Southeast Retina Center
- Rush University Medical Center
- DuPage Medical Group
- Kovach Eye Institute
- University Retina and Macula Associates
- Wheaton Eye Clinic, Clinical Research Center, LLC
- Sabates Eye Centers
- Paducah Retinal Center
- The Retina Care Center
- Cumberland Valley Retina Consultants, P.C.
- Vitreo-Retinal Associates, Pc
- Retina Specialists of Michigan
- University of Mississippi Medical Center
- Retina Center of New Jersey, LLC
- Delaware Valley Retina Associates
- Long Island Vitreoretinal Consultants
- Maculacare - New York
- Retina Vitreous Surgeons of Central NY, PC
- Western Carolina Retinal Associates, PA
- Charlotte Eye Ear Nose & Throat Associates, PA
- Retina Associates of Cleveland, Inc
- Cincinnati Eye Institute
- Ohio State University
- Midwest Retina, Inc.
- Retina & Vitreous Center SO, PC
- Oregon Health Sciences University
- Pennsylvania Retina Specialists, P.C.
- Black Hills Regional Eye Institute
- Austin Retina Associates
- Retina and Vitreous of Texas
- The University of Texas Medical Branch
- Premiere Retina Specialists
- Retina Associates of South Texas, PA
- Strategic Clinical Research Group, LLC
- University of Utah, John Moran Eye Center
- Virginia Eye Consultants
- Wagner Macula and Retina Center
- Vitreoretinal Associates of Washington
- Spokane Eye Clinical Research
- West Virginia University Eye Institute
- Save Sight Institute, University of Sydney Eye Hospital
- Sydney Retina Clinic and Day Surgery
- Sydney West Retina
- Centre for Eye Research Australia
- Specialist Eye Group
- Lions Eye Institute
- Centro Brasileiro de Cirurgia de Olhos - CBCO
- Instistuto da Visao - Hospital de Olhos Ltda
- Hospital Oftalmologico de Sorocaba
- Clinica de Olhos Dr. Suel Abujamra
- Instituto Da Visao UNIFESP EPM (Universidade Federal de Sao Paulo - Escola Paulista de Medicina)
- Calgary Retina Consultants
- St Joseph's Health Care London - Ivey Eye Institute
- Canadian Centre for Advanced Eye Therapeutics Inc
- University of Ottawa Eye Institute
- Toronto Retina Institute
- Rigshospitalet-Glostrup
- Odense University Hospital
- Magyar Honvedseg Egeszegugyi Kozpont
- Semmelweis University
- Bajcsy-Zsilinszky Hospital
- Szent Imre Teaching Hospital
- Budapest Retina Associates Kft.
- University of Debrecen, Medical Center
- Ganglion Medical Centre
- University of Szeged
- Markusovszki Teaching Hospital
- Ospedale Clinicizzato
- Clinica Oculistica, Ospedale Santa Maria della Misericordia
- Eye Clinic - Fondazione IRCCS
- Clinica Oculistica- Dipartimento di Scienze Cliniche Universita di Milano
- Ospedale Molinette
- Azienda Ospedaliero-Universitaria Careggi - SOD Oculistica, Dipartimento di Chirurgia e Medicina Traslazionale
- Azienda Universitaria Ospedaliera Pisana, Ospedale "Nuovo S.Chiara" Cisanello
- IRCCS - Istuto di Recovero e Cura a Carattere Scientifico
- A.O.U. Policlinico Sant Orsola Malpighi Pad1, 4Piano, Studio Medici via Pelagio Palagi 9
- Clinica Oculistica DINOGMI Universita di Genova
- IRCCS Ospedale San Raffaele
- Policlinico Agostino Gemelli
- Fondazione G.B. Bietti-IRCCS
- Aichi Medical University Hospital
- Japan Community Health Care Organization Chukyo Hospital
- Nagoya University Hospital
- Kameda Clinic
- Toho University Sakura Medical Center
- Juntendo University Urayasu Hospital
- Ogaki Tokushukai Hospital
- Kimura Eye And Internal Medicine Hospital
- Sapporo City General Hospital
- Hyogo Prefectural Amagasaki Hospital General Medical Center
- Tokyo Medical University Ibaraki Medical Center
- Mito Kyodo General Hospital
- Otakeganka Tsukimino Clinic
- Kikuna Yuda Eye Clinic
- Mie University Hospital
- Iida Municipal Hospital
- Shiga University of Medical Science Hospital
- Seirei Hamamatsu General Hospital
- Nihon University Hospital
- Chofu Eye Clinic
- Tokyo Medical University Hachioji Medical Center
- Takeuchi Eye Clinic
- Kyushu University Hospital
- Fukushima Medical University Hospital
- Kokura Kinen Hospital
- Ideta Eye Hospital
- The Japanese Red Cross Nagasaki Genbaku Hospital
- Nara Medical University Hospital
- Medical Corporation Jinshikai Nishi Eye Hospital
- Musashi Dream Clinic
- Tane Memorial Eye Hospital
- Tokyo Women's Medical University Hospital
- Elisabeth Hospital
- Academic Medical Center
- Oogziekenhuis Rotterdam
- Leiden University Medical Center
- Macula D&T Eye Center
- Optimum Profesorskie Centrum Okulistyki
- Klinika Okulistyczna Jasne Blonia
- Centrum Diagnostyki i Mikrochirurgii
- Retina Eye Hospital
- Uniwersytecki Szpital Kliniczny
- Scientific Research Institute of Ocular Diseases of RAMS
- S. Fyodorov Eye Microsurgery Federal State Institution
- Pasteur Medical Centre
- Dr Actons Privat Practice
- Pretoria Eye Institute, Private Practice
- Department of Ophthalmology Kaohsiung Veterans General Hospital
- Kaohsiung Chang Gung Memorial Hospital
- Department of Ophthalmology National Taiwan University Hospital
- Shin Kong Wu Ho-Su Memorial Hospital
- Chang Gung Medical Foundation, Linkou Branch
- Ankara Uni Med Fac
- Dokuz Eylul Uni Med Fac
- Frimley Park Hospital
- Royal Derby Hospital
- ESNEFT Essex County Hospital
- University Hospital Southampton
- Oxford Eye Hospital, John Radcliffe Hospital
- Royal Liverpool University Hospital
- Royal Surrey Hospital
- Heart of England NHS Foundation Trust, Good Hope Hospital
- University Hospital of Wales
- Bradford Royal Infirmary (BRI)
- Sheffield Teaching Hospitals
- Barnet Hospital
- Bristol Eye Hospital
- University Hospital Aintree
- Moorfields Eye Hospital
- Barnet Royal Free Hospital
- King's College Hospital
- Royal Victoria Infirmary
- Hospital of St. Cross
- City Hospitals Sunderland NHS
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Abicipar Pegol 2 mg (2Q8)
Abicipar Pegol 2 mg (2Q12)
Ranibizumab (rQ4)
Abicipar 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 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 (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.