Safety and Efficacy of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration

Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration (SEQUOIA Study)

This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration.

Study Overview

• Status: Completed
• Conditions: Macular Degeneration
• Intervention / Treatment: Drug: Abicipar Pegol; Other: Sham Procedure; Drug: Ranibizumab

• Study Type: Interventional
• Enrollment (Actual): 949
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abicipar Pegol 2 mg (2Q8); 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.	Drug: Abicipar Pegol; Abicipar pegol intravitreal injection.; Other Names: AGN-150998; Other: Sham Procedure; Sham injection.
Experimental: Abicipar Pegol 2 mg (2Q12); 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.	Drug: Abicipar Pegol; Abicipar pegol intravitreal injection.; Other Names: AGN-150998; Other: Sham Procedure; Sham injection.
Active Comparator: Ranibizumab (rQ4); Ranibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.	Drug: Ranibizumab; Ranibizumab intravitreal injection.; Other Names: Lucentis®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) in the Study Eye at 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.	Baseline to Week 52
Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at 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.	Baseline to Week 52
Percentage of Participants With BCVA Gain of More Than 15 Letters From Baseline in the Study Eye at 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.	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	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.	Baseline to Week 52

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Joanne Li, Allergan

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2015
• Primary Completion (Actual): April 12, 2018
• Study Completion (Actual): June 6, 2019

Study Registration Dates

• First Submitted: June 2, 2015
• First Submitted That Met QC Criteria: June 2, 2015
• First Posted (Estimate): June 4, 2015

Study Record Updates

• Last Update Posted (Actual): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 17, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: 150998-006; 2014-004580-20 (EudraCT Number); SEQUOIA (Other Identifier: Allergan)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No