A Safety and Efficacy Study of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration
- Conditions
- Macular Degeneration
- Interventions
- Registration Number
- NCT02462928
- Lead Sponsor
- Allergan
- Brief Summary
This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 939
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Abicipar Pegol 2 mg (2Q8) Abicipar Pegol Abicipar 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. Abicipar Pegol 2 mg (2Q12) Sham Procedure Abicipar 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. Abicipar Pegol 2 mg (2Q8) Sham Procedure Abicipar 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. Ranibizumab 0.5 mg (rQ4) Ranibizumab Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96. Abicipar Pegol 2 mg (2Q12) Abicipar Pegol Abicipar 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Stable Vision at Week 52 Baseline to 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.
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline in BCVA in the Study Eye at Week 52 Baseline to 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.
Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in Study Eye at Week 52 Baseline to 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.
Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52 Baseline to 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.
Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score in Study Eye at Week 52 Baseline to 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.
Trial Locations
- Locations (151)
Instituto Oftalmologica Profesor Arentsen
🇨🇱Santiago, Región Metropolitana, Chile
Asian Eye Institute
🇵🇭Makati City, Metro Manila, Philippines
St. Luke's Medical Center
🇵🇭Quezon City, Metro Manila, Philippines
Long Island Vitreoretinal Consultants
🇺🇸Great Neck, New York, United States
The Bert M Glaser National Retina Institute
🇺🇸Towson, Maryland, United States
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 Clinico San Carlos
🇪🇸Madrid, Spain
Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Augenheilkunde
🇩🇪Leipzig, Germany
Doheny Vision Research
🇺🇸Pasadena, California, United States
Retina Consultants of Orange County
🇺🇸Fullerton, California, United States
Retina Institute of California
🇺🇸Palm Desert, California, United States
Retina Vitreous Associates of Florida - Saint Petersburg
🇺🇸Saint Petersburg, Florida, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
Carolina Eye Associates
🇺🇸Southern Pines, North Carolina, United States
Fakultni nemocnice Olomouc
🇨🇿Olomouc, Czechia
Clinica Privada Kaufer Cataract Center
🇦🇷Martinez, Buenos Aires, Argentina
Medical University Graz
🇦🇹Graz, Austria
Hopital Pellegrin
🇫🇷Bordeaux, France
Dardenne Eye Hospital
🇩🇪Bad Godesberg, Germany
Augenklinik im Dietrich-Bonhoeffer - Klinikum Neubrandenburg
🇩🇪Neubrandenburg, Germany
Rambam Health Care Campus
🇮🇱Haifa, Israel
Clinic and policlinic of ophthalmology, University of Regensburg
🇩🇪Regensburg, Germany
Bnai Zion Medical Center (BZMC) Technion-Israel Institute of Technology
🇮🇱Haifa, Israel
Edith Wolfson Medical Center
🇮🇱Holon, Israel
Carmel Medical Center Ophthalmology Clinic
🇮🇱Haifa, Israel
Kaplan Medical Center
🇮🇱Rehovot, Israel
Shamir Medical Centre
🇮🇱Zerifin, Israel
TASMC (The Tel-Aviv Sourasky Medical Centre)
🇮🇱Tel Aviv, Israel
Chaim Sheba Medical Center Goldschleger Eye Clinic Sheba Medical Center
🇮🇱Tel Hashomer, Israel
The Catholic Univ. Of Seoul St. Mary's Hospital
🇰🇷Seocho, Seoul, Korea, Republic of
University of Auckland
🇳🇿Auckland, New Zealand
National University Hospital
🇸🇬Singapore, Singapore
Singapore National Eye Centre- Singapore Eye Research Institute (SNECSERI)
🇸🇬Singapore, Singapore
Instituto Clínico Quirúrgico de Oftalmología (ICQO)
🇪🇸Bilbao, Spain
Clinica Universidad de Navarra Servicio de Oftalmologia
🇪🇸Pamplona, Spain
Universitatsklinik fur Augenheilkunde, Inselspital
🇨🇭Bern, Switzerland
VISTA Klinik Binningen
🇨🇭Binningen, Switzerland
Hospital General de Valencia Unidad de Investigacion Clinica
🇪🇸Valencia, Spain
Stiftung für wissenschaftliche Forschung am Stadtspital Triemli
🇨🇭Zurich, Switzerland
Centro Privado de Ojos Romagosa
🇦🇷Cordoba, Argentina
Colorado Retina Associates
🇺🇸Golden, Colorado, United States
Mark B. Kislinger MD Inc.
🇺🇸Glendora, California, United States
Hospital Miguel Servet
🇪🇸Zaragoza, Spain
Retina Associates Southwest, P.C.
🇺🇸Tucson, Arizona, United States
The Retina Partners
🇺🇸Encino, California, United States
Atlantis Retina Institute (Atlantis Eyecare)
🇺🇸Huntington Beach, California, United States
Northern California Retina Vitreous Associates Medical Group, INC.
🇺🇸Mountain View, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
California Retina Consultants
🇺🇸Santa Barbara, California, United States
Orange County Retina Medical Group
🇺🇸Santa Ana, California, United States
Retina Eye Specialists
🇺🇸South Pasadena, California, United States
Retina Health Center
🇺🇸Fort Myers, Florida, United States
Florida Retina Consultants
🇺🇸Lakeland, Florida, United States
Mayo Clinic Florida
🇺🇸Jacksonville, Florida, United States
Ocala Eye PA
🇺🇸Ocala, Florida, United States
Retina Care Specialists
🇺🇸Palm Beach Gardens, Florida, United States
Retina Specialty Institute
🇺🇸Pensacola, Florida, United States
Georgia Retina, P.C.
🇺🇸Marietta, Georgia, United States
Gailey Eye Clinic
🇺🇸Bloomington, Illinois, United States
Retina Consultants of Hawaii, Inc.
🇺🇸'Aiea, Hawaii, United States
Marietta Eye Clinic - Main Office
🇺🇸Marietta, Georgia, United States
University Retina and Macula Associates, PC
🇺🇸Lemont, Illinois, United States
Carle at the Fields
🇺🇸Champaign, Illinois, United States
John Kenyon American Eye Institute
🇺🇸New Albany, Indiana, United States
Retina Specialists
🇺🇸Baltimore, Maryland, United States
Capital Region Retina, PLLC
🇺🇸Albany, New York, United States
Retina Associates of New Jersey
🇺🇸Teaneck, New Jersey, United States
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States
Island Retina
🇺🇸Shirley, New York, United States
Ophthalmic Consultants of Long Island
🇺🇸Oceanside, New York, United States
Apex Eye Clinical Research
🇺🇸Fairfield, Ohio, United States
Lancaster Retina Specialists
🇺🇸Lancaster, Pennsylvania, United States
Associates in Ophthalmology, Ltd.
🇺🇸West Mifflin, Pennsylvania, United States
Retina Consultants of Carolina
🇺🇸Greenville, South Carolina, United States
Charleston Neuroscience Institute
🇺🇸Ladson, South Carolina, United States
Retina Research Institute of Texas
🇺🇸Abilene, Texas, United States
TX Retina Associates
🇺🇸Dallas, Texas, United States
Retina Consultants of Houston
🇺🇸The Woodlands, Texas, United States
University of Virginia - Department of Ophthalmology
🇺🇸Charlottesville, Virginia, United States
Hospital Universitario Austral
🇦🇷Pilar, Buenos Aires, Argentina
Piedmont Eye Center, Inc.
🇺🇸Lynchburg, Virginia, United States
Centro Oftalmologico Rosario SRL
🇦🇷Rosario, Santa Fe, Argentina
Grupo Laser Vision
🇦🇷Rosario, Santa Fe, Argentina
Organizacion Medica de Investigacion
🇦🇷Buenos Aires, Argentina
Instituto Oftalmologico de Buenos Aires - Oftalmos
🇦🇷Buenos Aires, Argentina
Medizinische Universitat Innsbruck, Univ.
🇦🇹Innsbruck, Austria
Oftar Centro Privado de Oftalmologia
🇦🇷Mendoza, Argentina
Instituto Oftalmologico de Cordoba
🇦🇷Cordoba, Argentina
Kepler Universitatsklinikum GmBH
🇦🇹Linz, Austria
Konventhospital Barmherzige Brueder Linz
🇦🇹Linz, Austria
KYDOFT
🇨🇱Santiago, Las Condes, Chile
Fundacion Oftalmologica Nacional - FUNDONAL
🇨🇴Bogota, Colombia
Fakultni nemocnice Brno
🇨🇿Brno, Czechia
Centre Hospitalier Intercommunal de Creteil
🇫🇷Creteil, France
Fakultni nemocnice Kralovske Vinohrady Oftalmologicka klinika
🇨🇿Praha, Czechia
Vseobecna fakultni nemocnice v Praze Ocni Klinika
🇨🇿Praha, Czechia
CHU de Nantes
🇫🇷Nantes Cedex 1, France
Centre Ophtalmologique d'Imagerie et de Laser
🇫🇷Paris, France
Hopital de la Croix Rousse, Service d'Opthalmologie
🇫🇷Lyon cedex 04, France
Centre Ophtalmologique Saint Exupery
🇫🇷Saint Cyr sur Loire, France
Klinikum Dresden Friedrichstadt
🇩🇪Dresden, Germany
Internationale Innovative Ophthalmochirurgie Breyer & Kaymak & Klabe Augenchirurgie
🇩🇪Dusseldorf, Germany
Universitats-augenklinik Gottingen
🇩🇪Gottingen, Germany
Eye Center, University of Freiburg
🇩🇪Freiburg, Germany
Stadtisches Klinikum
🇩🇪Karlsruhe, Germany
Universitätsklinikum Giessen und Marburg GmbH
🇩🇪Marburg, Germany
The Chinese University of Hong Kong Hongkong eye hospital
🇭🇰Kowloon, Hong Kong
Rabin Medical Center Beilinson Hospital
🇮🇱Petach Tikva, Israel
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Auckland Eye
🇳🇿Remuera, Auckland, New Zealand
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Yonsei University Health System Serverance Hospital
🇰🇷Seoul, Korea, Republic of
Pauls Stradins Clinical University Hospital Opthalmology Clinic
🇱🇻Riga, LV, Latvia
Cebu Doctors University Hospital
🇵🇭Cebu City, Metro Manila, Philippines
Pacific Eyecare and Laser Institute
🇵🇭Makati City, Metro Manila, Philippines
The Medical City
🇵🇭Pasig City, Metro Manila, Philippines
Centro de Oftalmologia Barraquer
🇪🇸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
Hospital Universitario de Bellvitge
🇪🇸Barcelona, Spain
Valles Oftalmologia Research Hospital
🇪🇸Barcelona, Spain
Lahey Medical Center
🇺🇸Peabody, Massachusetts, United States
Texas Retina Associates
🇺🇸Arlington, Texas, United States
Thomas Eye Group, PC
🇺🇸Sandy Springs, Georgia, United States
Retina Associates of Western New York
🇺🇸Rochester, New York, United States
Mid Atlantic Retina
🇺🇸Philadelphia, Pennsylvania, United States
Texan Eye
🇺🇸Austin, Texas, United States
Meir Medical Center
🇮🇱Kfar-Saba, Israel
Magruder Eye Institute
🇺🇸Orlando, Florida, United States
USF Eye Institute
🇺🇸Tampa, Florida, United States
Raj K. Maturi, MD, PC
🇺🇸Indianapolis, Indiana, United States
Retina and Vitreous of Texas
🇺🇸Houston, Texas, United States
Retinal Consultants of Houston
🇺🇸Houston, Texas, United States
San Antonio Eye Center
🇺🇸San Antonio, Texas, United States
Retinal Research Institute, LLC
🇺🇸Phoenix, Arizona, United States
Associated Retina Consultants, Ltd.
🇺🇸Phoenix, Arizona, United States
Arizona Retina and Vitreous Consultants
🇺🇸Phoenix, Arizona, United States
Kellog Eye Center - University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Ochsner Health Center
🇺🇸New Orleans, Louisiana, United States
Wake Forest Baptist Health Eye Center
🇺🇸Winston-Salem, North Carolina, United States
Houston Eye Associates (HEA) - Gramercy Location
🇺🇸Houston, Texas, United States
Retinal Consultants of San Antonio
🇺🇸San Antonio, Texas, United States
Retina Associates of Utah
🇺🇸Salt Lake City, Utah, United States
Retina Institute of Virginia
🇺🇸Richmond, Virginia, United States
Medical Center Ophthalmology Associates
🇺🇸San Antonio, Texas, United States
Centro Medico Imbanaco
🇨🇴Cali, Valle Del Cauca, Colombia
The University of Hong Kong
🇭🇰Aberdeen, Hong Kong