Safety and Efficacy of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration
- Conditions
- Macular Degeneration
- Interventions
- Registration Number
- NCT02462486
- 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
- 949
- 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 (2Q12) Sham Procedure 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. 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, 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) Abicipar Pegol 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 (rQ4) Ranibizumab Ranibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96. 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, 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Stable Vision at Week 52 Baseline to 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.
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 52 Baseline to Week 52 BCVA was 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. Mixed-effect model for repeated measures (MMRM) analysis was used. Study eye is 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.
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 that provides high-resolution imaging sections of the retina. SD-OCT is performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement and a positive change from baseline indicates worsening. Study eye is 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. MMRM analysis was used.
Percentage of Participants With BCVA Gain of More Than 15 Letters From Baseline in the Study Eye at Week 52 Baseline to Week 52 BCVA is measured using an eye chart and is 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 gain of more than 15 letters are noted. Study eye is 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.
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 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. Overall composite score is then calculated by averaging over all 11 vision-targeted subscale scores, excluding general health score. Overall composite score was calculated based on mean of non-missing subscales. Study eye: 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 (187)
Paducah Retinal Center
🇺🇸Paducah, Kentucky, United States
Maculacare - New York
🇺🇸New York, New York, United States
Retina Vitreous Surgeons of Central NY, PC
🇺🇸Syracuse, New York, United States
Long Island Vitreoretinal Consultants
🇺🇸Hauppauge, New York, United States
Charlotte Eye Ear Nose & Throat Associates, PA
🇺🇸Charlotte, North Carolina, United States
Win Retina
🇺🇸Arcadia, California, United States
Northwest Arkansas Retina Associates
🇺🇸Springdale, Arkansas, United States
Retina Institute of California
🇺🇸Arcadia, California, United States
Specialty Eye Care Medical Center, Inc.
🇺🇸Glendale, California, United States
Retinal Diagnostic Center
🇺🇸Campbell, California, United States
University of California at Irvine Gavin Herbert Eye Institute
🇺🇸Irvine, California, United States
Retina Associates of Orange County
🇺🇸Laguna Hills, California, United States
South Coast Retina Center
🇺🇸Long Beach, California, United States
San Diego Retina Associates
🇺🇸Oceanside, California, United States
California Eye Specialist Medical Group
🇺🇸Pasadena, California, United States
Southern California Desert Retina Consultants
🇺🇸Palm Desert, California, United States
Retina Consultants of Southern California
🇺🇸Redlands, California, United States
Retina Consultants, San Diego
🇺🇸Poway, California, United States
Kaiser Permanente Riverside Medical Center
🇺🇸Riverside, California, United States
The Eye Associates
🇺🇸Bradenton, Florida, United States
National Ophthalmic Research Institute
🇺🇸Fort Myers, Florida, United States
Fort Lauderdale Eye Institute
🇺🇸Plantation, Florida, United States
East Florida Eye Institute
🇺🇸Stuart, Florida, United States
Sarasota Retina Institute
🇺🇸Sarasota, Florida, United States
Center for Retina and Macular Disease
🇺🇸Winter Haven, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Southeast Retina Center
🇺🇸Augusta, Georgia, United States
Kovach Eye Institute
🇺🇸Elmhurst, Illinois, United States
DuPage Medical Group
🇺🇸Downers Grove, Illinois, United States
University Retina and Macula Associates
🇺🇸Oak Forest, Illinois, United States
Wheaton Eye Clinic, Clinical Research Center, LLC
🇺🇸Wheaton, Illinois, United States
Sabates Eye Centers
🇺🇸Leawood, Kansas, United States
The Retina Care Center
🇺🇸Baltimore, Maryland, United States
Cumberland Valley Retina Consultants, P.C.
🇺🇸Hagerstown, Maryland, United States
Retina Specialists of Michigan
🇺🇸Grand Rapids, Michigan, United States
Vitreo-Retinal Associates, Pc
🇺🇸Worcester, Massachusetts, United States
Delaware Valley Retina Associates
🇺🇸Lawrenceville, New Jersey, United States
Western Carolina Retinal Associates, PA
🇺🇸Asheville, North Carolina, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Retina Associates of Cleveland, Inc
🇺🇸Beachwood, Ohio, United States
Pennsylvania Retina Specialists, P.C.
🇺🇸Camp Hill, Pennsylvania, United States
Retina & Vitreous Center SO, PC
🇺🇸Ashland, Oregon, United States
Midwest Retina, Inc.
🇺🇸Dublin, Ohio, United States
The University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Strategic Clinical Research Group, LLC
🇺🇸Willow Park, Texas, United States
Retina and Vitreous of Texas
🇺🇸Beaumont, Texas, United States
Premiere Retina Specialists
🇺🇸Midland, Texas, United States
Retina Associates of South Texas, PA
🇺🇸San Antonio, Texas, United States
Virginia Eye Consultants
🇺🇸Norfolk, Virginia, United States
Wagner Macula and Retina Center
🇺🇸Virginia Beach, Virginia, United States
Vitreoretinal Associates of Washington
🇺🇸Bellevue, Washington, United States
Spokane Eye Clinical Research
🇺🇸Spokane, Washington, United States
West Virginia University Eye Institute
🇺🇸Morgantown, West Virginia, United States
Save Sight Institute, University of Sydney Eye Hospital
🇦🇺Sydney, New South Wales, Australia
Sydney Retina Clinic and Day Surgery
🇦🇺Sydney, New South Wales, Australia
Sydney West Retina
🇦🇺Westmead, New South Wales, Australia
Centre for Eye Research Australia
🇦🇺East Melbourne, Victoria, Australia
Specialist Eye Group
🇦🇺Glen Waverley, Victoria, Australia
Lions Eye Institute
🇦🇺Nedlands, Western Australia, Australia
Centro Brasileiro de Cirurgia de Olhos - CBCO
🇧🇷Goiania, Goias, Brazil
Clinica de Olhos Dr. Suel Abujamra
🇧🇷Sao Paulo, Brazil
Instistuto da Visao - Hospital de Olhos Ltda
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Canadian Centre for Advanced Eye Therapeutics Inc
🇨🇦Mississauga, Ontario, Canada
Hospital Oftalmologico de Sorocaba
🇧🇷Sorocaba, Sao Paulo, Brazil
Calgary Retina Consultants
🇨🇦Calgary, Alberta, Canada
St Joseph's Health Care London - Ivey Eye Institute
🇨🇦London, Ontario, Canada
University of Ottawa Eye Institute
🇨🇦Ottawa, Ontario, Canada
Toronto Retina Institute
🇨🇦Toronto, Ontario, Canada
Ganglion Medical Centre
🇭🇺Pecs, Hungary
Budapest Retina Associates Kft.
🇭🇺Budapest, Hungary
Clinica Oculistica- Dipartimento di Scienze Cliniche Universita di Milano
🇮🇹Milan, Lombardy, Italy
Markusovszki Teaching Hospital
🇭🇺Szombathely, Hungary
Eye Clinic - Fondazione IRCCS
🇮🇹Milan, Lombardy, Italy
Azienda Ospedaliero-Universitaria Careggi - SOD Oculistica, Dipartimento di Chirurgia e Medicina Traslazionale
🇮🇹Firenze, Tuscany, Italy
Ospedale Molinette
🇮🇹Torino, Piedmont, Italy
Azienda Universitaria Ospedaliera Pisana, Ospedale "Nuovo S.Chiara" Cisanello
🇮🇹Pisa, Tuscany, Italy
Japan Community Health Care Organization Chukyo Hospital
🇯🇵Nagoya, Aichi, Japan
Nagoya University Hospital
🇯🇵Nagoya, Aichi, Japan
Ogaki Tokushukai Hospital
🇯🇵Ogaki, Gifu, Japan
Kameda Clinic
🇯🇵Kamogawa, Chiba, Japan
Juntendo University Urayasu Hospital
🇯🇵Urayasu, Chiba, Japan
Toho University Sakura Medical Center
🇯🇵Sakura, Chiba, Japan
Kimura Eye And Internal Medicine Hospital
🇯🇵Kure, Hiroshima, Japan
Hyogo Prefectural Amagasaki Hospital General Medical Center
🇯🇵Amagasaki, Hyogo, Japan
Sapporo City General Hospital
🇯🇵Sapporo, Hokkaido, Japan
Tokyo Medical University Ibaraki Medical Center
🇯🇵Inashiki, Ibaraki, Japan
Mito Kyodo General Hospital
🇯🇵Mito, Ibaraki, Japan
Otakeganka Tsukimino Clinic
🇯🇵Yamato, Kanagawa, Japan
Kikuna Yuda Eye Clinic
🇯🇵Kanagawa, Kanto, Japan
Mie University Hospital
🇯🇵Tsu, Mie, Japan
Iida Municipal Hospital
🇯🇵Iida, Nagano, Japan
Seirei Hamamatsu General Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
Takeuchi Eye Clinic
🇯🇵Taito, Tokyo, Japan
Nihon University Hospital
🇯🇵Chiyoda, Tokyo, Japan
Chofu Eye Clinic
🇯🇵Chofu, Tokyo, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Fukushima Medical University Hospital
🇯🇵Fukushima, Japan
Kokura Kinen Hospital
🇯🇵Kitakyushu, Japan
Ideta Eye Hospital
🇯🇵Kumamoto, Japan
The Japanese Red Cross Nagasaki Genbaku Hospital
🇯🇵Nagasaki, Japan
Nara Medical University Hospital
🇯🇵Nara, Japan
Medical Corporation Jinshikai Nishi Eye Hospital
🇯🇵Osaka, Japan
Tane Memorial Eye Hospital
🇯🇵Osaka, Japan
Tokyo Women's Medical University Hospital
🇯🇵Tokyo, Japan
Elisabeth Hospital
🇳🇱Tilburg, North Brabant, Netherlands
Leiden University Medical Center
🇳🇱Leiden, South Holland, Netherlands
Macula D&T Eye Center
🇵🇪San Isidro, Lima, Peru
Optimum Profesorskie Centrum Okulistyki
🇵🇱Gdansk, Poland
Centrum Diagnostyki i Mikrochirurgii
🇵🇱Olsztyn, Poland
Scientific Research Institute of Ocular Diseases of RAMS
🇷🇺Moscow, Russian Federation
Uniwersytecki Szpital Kliniczny
🇵🇱Wrocław, Poland
S. Fyodorov Eye Microsurgery Federal State Institution
🇷🇺Moscow, Russian Federation
Dr Actons Privat Practice
🇿🇦Cape Town, South Africa
Pasteur Medical Centre
🇿🇦Bloemfontein, South Africa
Pretoria Eye Institute, Private Practice
🇿🇦Pretoria, South Africa
Department of Ophthalmology Kaohsiung Veterans General Hospital
🇨🇳Kaohsiung, Taiwan
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Chang Gung Medical Foundation, Linkou Branch
🇨🇳Taoyuan, Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
🇨🇳Taipei, Taiwan
Ankara Uni Med Fac
🇹🇷Ankara, Turkey
Royal Derby Hospital
🇬🇧Derby, Derbyshire, United Kingdom
Dokuz Eylul Uni Med Fac
🇹🇷Izmir, Turkey
Frimley Park Hospital
🇬🇧Frimley, Camberley, United Kingdom
ESNEFT Essex County Hospital
🇬🇧Colchester, Essex, United Kingdom
University Hospital Southampton
🇬🇧Southampton, Hampshire, United Kingdom
Heart of England NHS Foundation Trust, Good Hope Hospital
🇬🇧Sutton Coldfield, Staffordshire, United Kingdom
Royal Surrey Hospital
🇬🇧Guildford, South East, United Kingdom
Bradford Royal Infirmary (BRI)
🇬🇧Bradford, West Yorkshire, United Kingdom
Bristol Eye Hospital
🇬🇧Bristol, United Kingdom
Barnet Hospital
🇬🇧Barnet, United Kingdom
University Hospital Aintree
🇬🇧Liverpool, United Kingdom
Moorfields Eye Hospital
🇬🇧London, United Kingdom
Hospital of St. Cross
🇬🇧Rugby, United Kingdom
City Hospitals Sunderland NHS
🇬🇧Sunderland, United Kingdom
Barnet Royal Free Hospital
🇬🇧London, United Kingdom
King's College Hospital
🇬🇧London, United Kingdom
Retina Macula Specialists of Miami
🇺🇸Miami, Florida, United States
MedEye Associates
🇺🇸Miami, Florida, United States
Cincinnati Eye Institute
🇺🇸Cincinnati, Ohio, United States
Academic Medical Center
🇳🇱Amsterdam, North Holland, Netherlands
Oogziekenhuis Rotterdam
🇳🇱Rotterdam, North Holland, Netherlands
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Rigshospitalet-Glostrup
🇩🇰Glostrup, Hovedstaden, Denmark
Odense University Hospital
🇩🇰Odense, Syddanmark, Denmark
Barnet Dulaney Perkins Eye Center - Phoenix
🇺🇸Phoenix, Arizona, United States
University of Utah, John Moran Eye Center
🇺🇸Salt Lake City, Utah, United States
West Coast Retina Medical Group
🇺🇸San Francisco, California, United States
Pacific Eye Associates
🇺🇸San Francisco, California, United States
Eye Foundation Hospital
🇺🇸Birmingham, Alabama, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Ospedale Clinicizzato
🇮🇹Chieti, Abruzzi, Italy
Clinica Oculistica, Ospedale Santa Maria della Misericordia
🇮🇹Udine, Friuli-Venezia Giulia, Italy
IRCCS - Istuto di Recovero e Cura a Carattere Scientifico
🇮🇹Verona, Vento, Italy
A.O.U. Policlinico Sant Orsola Malpighi Pad1, 4Piano, Studio Medici via Pelagio Palagi 9
🇮🇹Bologna, Italy
Clinica Oculistica DINOGMI Universita di Genova
🇮🇹Genova, Italy
IRCCS Ospedale San Raffaele
🇮🇹Milano, Italy
Policlinico Agostino Gemelli
🇮🇹Roma, Italy
Fondazione G.B. Bietti-IRCCS
🇮🇹Roma, Italy
Oxford Eye Hospital, John Radcliffe Hospital
🇬🇧Oxford, Headington, United Kingdom
Sheffield Teaching Hospitals
🇬🇧Sheffield, Yorkshire, United Kingdom
Royal Victoria Infirmary
🇬🇧Newcastle, United Kingdom
Instituto Da Visao UNIFESP EPM (Universidade Federal de Sao Paulo - Escola Paulista de Medicina)
🇧🇷Sao Paulo, Brazil
Retina Vitreous Associates of Florida
🇺🇸Tampa, Florida, United States
Retina Associate of Florida, P.A.
🇺🇸Tampa, Florida, United States
Shiga University of Medical Science Hospital
🇯🇵Otsu, Shiga, Japan
Aichi Medical University Hospital
🇯🇵Nagakute, Aichi, Japan
Retinal Consultants of Arizona
🇺🇸Gilbert, Arizona, United States
Magyar Honvedseg Egeszegugyi Kozpont
🇭🇺Budapest, Hungary
Retina Center of New Jersey, LLC
🇺🇸Bloomfield, New Jersey, United States
University Hospital of Wales
🇬🇧Cardiff, Wales, United Kingdom
University of Szeged
🇭🇺Szeged, Hungary
Tokyo Medical University Hachioji Medical Center
🇯🇵Hachioji, Tokyo, Japan
Department of Ophthalmology National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Semmelweis University
🇭🇺Budapest, Hungary
Bajcsy-Zsilinszky Hospital
🇭🇺Budapest, Hungary
Retina Eye Hospital
🇵🇱Warsaw, Poland
Szent Imre Teaching Hospital
🇭🇺Budapest, Hungary
University of Debrecen, Medical Center
🇭🇺Debrecen, Hungary
Musashi Dream Clinic
🇯🇵Osaka, Japan
Klinika Okulistyczna Jasne Blonia
🇵🇱Lodz, Poland
Black Hills Regional Eye Institute
🇺🇸Rapid City, South Dakota, United States
Retinal Consultants Medical Group, Inc.
🇺🇸Sacramento, California, United States
UC Davis Medical Center, Department of Ophthalmology
🇺🇸Sacramento, California, United States
Austin Retina Associates
🇺🇸Austin, Texas, United States
Retina Centers, PC
🇺🇸Tucson, Arizona, United States
East Bay Retina Consultants, Inc.
🇺🇸Oakland, California, United States
Royal Liverpool University Hospital
🇬🇧Liverpool, North West England, United Kingdom