Study of the Effects of High Dose Aflibercept Injected Into the Eye of Patients With an Age-related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye (PULSAR)

Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of High Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration

In this study researchers want to learn more about changes in visual acuity (clarity of vision) with a high dose treatment with Aflibercept (Eylea) in patients suffering from neovascular age-related macular degeneration (nAMD). Neovascular AMD is an eye disease that causes blurred vision or a blind spot due to abnormal blood vessels that leak fluid or blood into the light sensitive lining inside the eye (retina). The fluid buildup causes the central part of the retina (macula) responsible for sharp, straight-ahead vision to swell and thicken (edema), which distorts vision.

Study Overview

• Status: Completed
• Conditions: Neovascular Age-Related Macular Degeneration
• Intervention / Treatment: Drug: Aflibercept High Dose VEGF Trap-Eye (BAY86-5321); Drug: Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321)

• Study Type: Interventional
• Enrollment (Actual): 1011
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Auton. de Buenos Aires
    • Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1015ABO
      • Organización Médica de Investigación (OMI)
    • Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1120AAN
      • OFTALMOS, Instituto Oftalmologico de Alta Complejidad
• Australia
  • New South Wales
    • Albury, New South Wales, Australia, 2640
      • Eyeclinic Albury Wodonga
    • Parramatta, New South Wales, Australia, 2150
      • Marsden Eye Surgery Center
    • Sydney, New South Wales, Australia, 2000
      • Sydney Retina Clinic
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Hobart Eye Surgeons
• Austria
  • Vienna, Austria, 1140
    • Hanusch-Krankenhaus Wien
  • Carinthia
    • Klagenfurt, Carinthia, Austria, 9020
      • Klinikum Klagenfurt am Wörthersee
  • Styria
    • Graz, Styria, Austria, 8036
      • Medizinische Universität Graz
  • Upper Austria
    • Linz, Upper Austria, Austria, 4020
      • Kepler Universitätsklinikum Campus III
    • Linz, Upper Austria, Austria, 4021
      • Konventhospital Barmherzige Brüder Linz
• Bulgaria
  • Sofia, Bulgaria, 1784
    • Specialized Hospital for Active Treatment of Eye Diseases Zora
  • Sofia, Bulgaria, 1309
    • SEHAT Pentagram
  • Sofia, Bulgaria, 1408
    • Spec. Hosp. for Active Treatment for Eye Diseases Zrenie
  • Sofia, Bulgaria, 1431
    • University Multiprofile Hospital For Active Treatment 'Alexandrovska' EAD
  • Sofia, Bulgaria, 1618
    • Multiprofile Hospital for Active Treatment Sveta Sofia | Internal Diseases Department
  • Varna, Bulgaria, 9000
    • Sveta Petka Eye Hospital
• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • St.Joseph's Health Care-London
    • Toronto, Ontario, Canada, M3C 0G9
      • Toronto Retina Institute
  • Quebec
    • Boisbriand, Quebec, Canada, J7H1S6
      • Institut De L'Oeil Des Laurentides
• China
  • Beijing, China, 100032
    • Peking University People's Hospital
  • Beijing, China, 100000
    • Beijing Aier Intech Eye Hospital
  • Chongqing, China, 400020
    • Chongqing Aier Ophthalmology Hospital
  • Shanghai, China, 200080
    • Shanghai General Hospital
  • Shanghai, China, 200065
    • Shanghai Tongji Hospital of Tongji University
  • Tianjin, China, 300052
    • Tianjin Medical University General Hospital
  • Tianjin, China, 300384
    • Tianjin Medical University Eye Hospital
  • Tianjin, China, 300384
    • Tianjin Eye Hospital
  • Anhui
    • Hefei, Anhui, China, 230601
      • The Second Hospital of Anhui Medical University
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Beijing Hospital
  • Dongcheng District
    • Beijing, Dongcheng District, China, 100005
      • Beijing Tongren Hospital, Capital Medical University (East)
  • Fujian
    • Fuzhou, Fujian, China, TBC
      • The 1st Affiliated Hospital Fujian Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 634050
      • Guangzhou Aier Eye Hospital
  • Hebei
    • Hebei, Hebei, China, 050010
      • Hebei Eye Hospital
    • Shijiazhuang, Hebei, China, 50000
      • Shijiazhuang General Hospital
  • Henan
    • Henan, Henan, China, 450008
      • Henan Provincial Eye Hospital
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
    • Wuhan, Hubei, China, 430030
      • Union Hospt Tongji Medical Colleg. Huazhong univ. Scien&Tech
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221002
      • The First People's Hospital of Xuzhou
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The First Affiliated Hospital of Nanchang University
    • Nanchang, Jiangxi, China, 330006
      • Jiangxi Provincial People's Hospital
  • Jilin
    • Changchun, Jilin, China, 130022
      • Eye Center of the second Bethune Hospital, jinlin University
    • Tonghua, Jilin, China, 134001
      • Tonghua Central Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110034
      • Shenyang He Eye Specialist Hospital
  • Ningxia
    • Ningxia, Ningxia, China, 750002
      • People's Hospital of Ningxia Hui Autonomous Region - Opthalmology
  • Shanxi
    • Xi’an, Shanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Sichuan
    • Chengdu, Sichuan, China
      • Aier Eye Hospital (Chengdu)
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830011
      • The First Affiliated Hospital of Xinjiang Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310014
      • Zhejiang Provincial People's Hospital
    • Hangzhou, Zhejiang, China, 310000
      • The 1st Affiliated Hospital of Zhejiang University
    • Wenzhou, Zhejiang, China
      • The Affiliated Eye Hospital of Wenzhou Medical College
• Czechia
  • Hradec Králové, Czechia, 500 05
    • Fakultni Nemocnice Hradec Kralove
  • Ostrava, Czechia, 708 52
    • Fakultni Nemocnice Ostrava
  • Plzen-Lochotin, Czechia, 323 00
    • Fakultni nemocnice Plzen - Lochotin
  • Prague, Czechia, 150 00
    • Axon Clinical, s.r.o.
  • Prague, Czechia, 110 00
    • Charles University in Prague
  • Prague, Czechia, 10034
    • Fakultní Nemocnice Královské Vinohrady
  • Prague, Czechia, 140 00
    • Lexum a.s., Evropska ocni klinika
• Estonia
  • Tallinn, Estonia, 10138
    • AS Ida-Tallinna Keskhaigla - Oftalmoloogiakeskus
  • Tartu, Estonia, 50406
    • Sihtasutus Tartu Ülikooli Kliinikum - Silmakliinik
• France
  • Marseille, France, 13008
    • Centre d'Ophtalmologie - Paradis-Monticelli
  • Paris, France, 75475
    • AP-HP - Hopital Lariboisiere
  • Saint-Cyr-sur-Loire, France, 37540
    • Centre ophtalmologique Saint-Exupery
• Georgia
  • Kutaisi, Georgia, 4600
    • LTD "Clinic LJ" - Opthalmology
  • Tbilisi, Georgia, 0186
    • JSC "Evex Hospitals'
  • Tbilisi, Georgia, 105
    • LTD "Innova"
  • Tbilisi, Georgia, 114
    • LTD "Chichua Medical Center MZERA"
• Hungary
  • Budapest, Hungary, 1133
    • Budapest Retina Associates
  • Szeged, Hungary, 6720
    • Szent-Gyorgyi Albert Orvostudomanyi Egyetem
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Corporation
  • Haifa, Israel, 3436212
    • Lady Davis Carmel Medical Center
  • Jerusalem, Israel, 9112001
    • Hadassah Hebrew University Hospital Ein Kerem
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center
  • Ramat Gan, Israel, 5262000
    • Chaim Sheba Medical Center
  • Rehovot, Israel, 7610001
    • Kaplan Medical Center
  • Tel Aviv, Israel, 6789140
    • Assuta Medical Centers - HaShalom
• Italy
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    • Rome, Lazio, Italy, 00133
      • Azienda Ospedaliera Policlinico Universitario Tor Vergata
    • Rome, Lazio, Italy, 198
      • Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia
  • Lombardy
    • Milan, Lombardy, Italy, 20122
      • Asst Fatebenefratelli Sacco
    • Milan, Lombardy, Italy, 20132
      • Ospedale San Raffaele s.r.l. - Oculistica
  • Sardinia
    • Cagliari, Sardinia, Italy, 9042
      • Azienda Ospedaliero-Universitaria di Cagliari
  • Umbria
    • Perugia, Umbria, Italy, 6129
      • A.O. di Perugia
• Japan
  • Akita, Japan, 010-8543
    • Akita University Hospital
  • Fukuoka, Japan, 812-0011
    • Hayashi Eye Hospital
  • Fukushima, Japan, 960-1295
    • Fukushima Medical University Hospital
  • Hiroshima, Japan, 734-8551
    • Hiroshima University Hospital
  • Miyazaki, Japan, 889-1692
    • University of Miyazaki Hospital
  • Nagasaki, Japan, 852-8511
    • Japanese Red Cross Nagasaki Genbaku Hospital
  • Saitama, Japan, 330-8553
    • Japanese Red Cross Saitama Hospital
  • Tokushima, Japan, 770-8503
    • Tokushima University Hospital
  • Wakayama, Japan, 640-9558
    • Japanese Red Cross Wakayama Medical Center
  • Yamagata, Japan, 990-9585
    • Yamagata University Hospital
  • Aichi-ken
    • Ichinomiya, Aichi-ken, Japan, 491-8551
      • Daiyukai Daiichi Hospital
    • Nagakute, Aichi-ken, Japan, 480-1195
      • Aichi Medical University Hospital
    • Nagoya, Aichi-ken, Japan, 466-8560
      • Nagoya University Hospital
    • Nagoya, Aichi-ken, Japan, 467-8602
      • Nagoya City University Hospital
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan, 802-8555
      • Kokura Memorial Hospital
    • Kurume, Fukuoka, Japan, 830-0011
      • Kurume University Hospital
  • Fukushima
    • Kōriyama, Fukushima, Japan, 963-8052
      • Southern Tohoku Eye Clinic
  • Gunma
    • Maebashi, Gunma, Japan, 371-8511
      • Gunma University Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8604
      • Sapporo City General Hospital
    • Sapporo, Hokkaido, Japan, 062-0931
      • KKR Sapporo Medical Center
  • Hyōgo
    • Amagasaki, Hyōgo, Japan, 660-8550
      • Hyogo Prefectural Amagasaki General Medical Center
    • Kobe, Hyōgo, Japan, 650-0017
      • Kobe University Hospital
  • Ibaraki
    • Mito, Ibaraki, Japan, 310-0845
      • Kozawa Eye Hospital And Diabetes Center
  • Ishikawa-ken
    • Kahoku-gun, Ishikawa-ken, Japan, 920-0293
      • Kanazawa Medical University Hospital
    • Kanazawa, Ishikawa-ken, Japan, 920-8641
      • Kanazawa University Hospital
  • Kagawa-ken
    • Kita-gun, Kagawa-ken, Japan, 761-0793
      • Kagawa University Hospital
  • Kanagawa
    • Kawasaki, Kanagawa, Japan, 216-8511
      • St. Marianna University Hospital
    • Kawasaki, Kanagawa, Japan, 211-0053
      • Medical corporation Eiwakai Dannoue Ophthalmology clinic
    • Yamato, Kanagawa, Japan, 242-0001
      • Otakeganka Tsukimino Clinic
  • Mie-ken
    • Tsu, Mie-ken, Japan, 514-8507
      • Mie University Hospital
  • Nagano
    • Matsumoto, Nagano, Japan, 390-8621
      • Shinshu University Hospital
  • Nara
    • Kashihara, Nara, Japan, 634-8522
      • Nara Medical University Hospital
  • Oita Prefecture
    • Yufu, Oita Prefecture, Japan, 879-5593
      • Oita University Hospital
  • Okayama-ken
    • Kurashiki, Okayama-ken, Japan, 710-8522
      • Kurashiki Medical Center
    • Okayama, Okayama-ken, Japan, 700-8558
      • Okayama University Hospital
  • Okinawa
    • Nakagami, Okinawa, Japan, 903-0215
      • University of the Ryukyus Hospital
  • Osaka
    • Hirakata, Osaka, Japan, 573-1191
      • Kansai Medical University Hospital
    • Moriguchi, Osaka, Japan, 570-8507
      • Kansai Medical University Medical Center
    • Osakasayama-shi, Osaka, Japan, 589-8511
      • Kindai University Hospital
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8655
      • The University of Tokyo Hospital
    • Chuoku, Tokyo, Japan, 104-8560
      • St.Luke's International Hospital
    • Edogawa-ku, Tokyo, Japan, 134-0088
      • Nishikasai Inouye Eye Hospital
    • Hachiōji, Tokyo, Japan, 193-0998
      • Tokyo Medical University Hachioji Medical Center
    • Itabashi-ku, Tokyo, Japan, 174-0071
      • Tokiwadai Muranaka Eye Clinic
    • Meguro-ku, Tokyo, Japan, 152-8902
      • National Hospital Organization Tokyo Medical Center
    • Shinjuku-ku, Tokyo, Japan, 162-8666
      • Tokyo Women's Medical University Hospital
    • Shinjuku-ku, Tokyo, Japan, 160-8582
      • Keio University Hospital
  • Yamaguchi
    • Ube, Yamaguchi, Japan, 755-8505
      • Yamaguchi University Hospital
  • Yamanashi
    • Chūō, Yamanashi, Japan, 409-3898
      • University of Yamanashi Hospital
• Latvia
  • Riga, Latvia, LV-1038
    • Riga East Clinical University Hospital "Gailezers"
  • Riga, Latvia, LV-1009
    • Latvian American Eye Center
  • Riga, Latvia, 1002
    • Department of Ophthalmology
• Lithuania
  • Kaunas, Lithuania, LT-50161
    • Hospital of LT University of Health Sciences Kaunas Clinics
  • Klaipėda, Lithuania, LT-92288
    • PI Klaipedos University Hospital
  • Vilnius, Lithuania, LT-08661
    • Vilnius University Hospital Santaros Klinikos
• Portugal
  • Coimbra, Portugal, 3000-548
    • AIBILI
  • Coimbra, Portugal, 3000-548
    • Espaço Medico de Coimbra
  • Porto, Portugal, 4099-001
    • Centro Hospitalar Universitario do Porto
  • Porto, Portugal, 4434-502
    • Centro Hospitalar Vila Nova de Gaia e Espinho | Unit 1 - Clinical Research Center
  • Lisbon District
    • Lisbon, Lisbon District, Portugal, 1050-078
      • ALM Oftalmolaser - Oftalmologia Medica e Cirurgica
• Russia
  • Moscow, Russia, 119021
    • Scientific Research Institution of Ophthalmic Diseases
  • Moscow, Russia, 127486
    • FBSI IRTC Eye Microsurgery n.a. acad. S.N. Fyodorov
• Serbia
  • Belgrade, Serbia, 11000
    • Clinical Center of Serbia
  • Belgrade, Serbia, 11000
    • Clinical Hospital Center Zvezdara
  • Novi Sad, Serbia, 21000
    • Klinicki centar Vojvodine
• Singapore
  • Singapore, Singapore, 168751
    • Singapore National Eye Centre
  • Singapore, Singapore, 119074
    • National University Hospital Medical Centre
• Slovakia
  • Nitra, Slovakia, 950 01
    • Fakultna nemocnica Nitra
  • Trebišov, Slovakia, 075 01
    • Nemocnica s Poliklinikou Trebisov, Svet zdravia a.s.
  • Trenčín, Slovakia, 911 71
    • Fakultna nemocnica Trencin
  • Žilina, Slovakia, 012 07
    • Fakultna nemocnica s poliklinikou Zilina
• South Korea
  • Busan, South Korea, 49241
    • Pusan National University Hospital
  • Busan, South Korea, 612-862
    • Inje University Haeundae Paik Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital (b)
  • Seoul, South Korea, 06351
    • Samsung Medical Center - Oncology Department
  • Gangnam-gu
    • Seoul, Gangnam-gu, South Korea, 135-280
      • Nune Eye Hospital - Retina Center Ophthalmology
  • Gyeonggido
    • Seongnam-si, Gyeonggido, South Korea, 13620
      • Seoul National University Bundang Hospital
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 05505
      • Asan Medical Center - Oncology Department
• Spain
  • Barcelona, Spain, 8036
    • Hospital Clinic i Provincial de Barcelona
  • Barcelona, Spain, 8041
    • Hospital de la Santa Creu i Sant Pau | Gynecology Department
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofia - Oftalmologia
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia
  • Valencia, Spain, 46026
    • Hospital Universitario Y Politecnico La Fe - Oftalmologia
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet - Oftalmologia
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15706
      • Instituto Oftalmologico Gomez-Ulla S.L. - Oftalmologia
• Switzerland
  • Bern, Switzerland, TBC
    • Berner Augenklinik am Lindenhofspital
  • Zurich, Switzerland, 8063
    • Stadtspital Triemli
  • Canton of Vaud
    • Lausanne, Canton of Vaud, Switzerland, 1006
      • RétinElysée
• Taiwan
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 111
    • Shin Kong Wu Ho-Su Memorial Hospital
  • Taoyuan District, Taiwan, 33305
    • Chang Gung Memorial Hospital at Linkou
• Ukraine
  • Kropyvnytskyi, Ukraine, 25006
    • Private Enterprise Private Production Company "Acinus", Treatment and Diagnostic Center
  • Kyiv, Ukraine, 1024
    • Centralna Polyclinica MVS Ukraiiny
  • Poltava, Ukraine, 36011
    • Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85021-8865
      • Arizona Retina & Vitreous Consultants - Central Phoenix Phoenix
  • California
    • Fullerton, California, United States, 92835
      • Retina Consultants of Orange County - Fullerton
    • Mountain View, California, United States, 94040
      • Northern California Retina Vitreous Associates - Mountain View Office
    • Pasadena, California, United States, 91107
      • Azul Vision Pasadena
    • Poway, California, United States, 92064
      • Retina Consultants San Diego - Poway
    • Redlands, California, United States, 92374
      • Retina Consultants of Southern California
    • Riverside, California, United States, 92505
      • Kaiser Permanente Riverside Medical Center - Cardiology
    • San Diego, California, United States, 92037
      • Perlman Medical Offices at UC San Diego Health - Endocrinology
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Retina Consultants of Southern Colorado, PC
  • Connecticut
    • New London, Connecticut, United States, 06320
      • New England Retina Associates
  • Florida
    • Deerfield Beach, Florida, United States, 33064
      • Rand Eye Institute
    • Fort Lauderdale, Florida, United States, 33308
      • Retina Group of Florida - Fort Lauderdale
    • Gainesville, Florida, United States, 32607-2557
      • Vitreo Retinal Associates PA - The Millennium Center Location
    • Jacksonville, Florida, United States, 32204
      • Florida Retina Institute- Jacksonville Oak
    • Melbourne, Florida, United States, 32901
      • Florida Eye Associates - Melbourne Main Office
    • Miami, Florida, United States, 33126
      • Retina Macula Specialists of Miami - LeJeune Road Office
    • Orlando, Florida, United States, 32806
      • Florida Retina Institute - Orlando
    • Pensacola, Florida, United States, 32503
      • Retina Specialty Institute - Pensacola
    • St. Petersburg, Florida, United States, 33711
      • Retina Vitreous Associates of Florida - Saint Petersburg
    • Tallahassee, Florida, United States, 32308
      • Southern Vitreoretinal Associates, P.L. - Tallahassee
  • Hawaii
    • ‘Aiea, Hawaii, United States, 96701
      • Retina Consultants of Hawaii - Pali Momi Medical Center
  • Illinois
    • Elmhurst, Illinois, United States, 60126
      • Retina Associates IL
    • Oak Forest, Illinois, United States, 60452
      • University Retina and Macula Associates
  • Iowa
    • West Des Moines, Iowa, United States, 50266-7705
      • Wolfe Eye Clinic - Des Moines
  • Maryland
    • Baltimore, Maryland, United States, 21209
      • The Retina Care Center - Baltimore
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Ophthalmic Consultants of Boston - Boston
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Vitreo Retinal Surgery PA - Edina
  • Nevada
    • Las Vegas, Nevada, United States, 89144
      • Retina Consultants of Nevada - Summerlin
  • New Jersey
    • Bloomfield, New Jersey, United States, 07003
      • Retina Center of New Jersey
    • Edison, New Jersey, United States, 08820
      • NJ Retina - Edison Office
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Eye Associates of New Mexico - Albuquerque - Retina Center
  • New York
    • Great Neck, New York, United States, 11021
      • Long Island Vitreoretinal Consultants - Great Neck
    • Hauppauge, New York, United States, 11788
      • Vitreoretinal Consultants of NY - Hauppauge
    • Lynbrook, New York, United States, 11563
      • Ophthalmic Consultants of Long Island
    • Troy, New York, United States, 12180
      • Ophthalmic Consultants of the Capital Region - Troy
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health
  • Ohio
    • Dublin, Ohio, United States, 43016
      • Midwest Retina - Main Office
  • Oregon
    • Portland, Oregon, United States, 97210
      • Retina Northwest - NW Lovejoy
    • Salem, Oregon, United States, 97302
      • Retina Consultants, LLC
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Mid Atlantic Retina - Philadelphia / Wills Eye Hospital
    • Erie, Pennsylvania, United States, 16507
      • Erie Retinal Research
    • Kingston, Pennsylvania, United States, 18704
      • Eye Care Specialists - Kingston, PA
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Charleston Neuroscience Institute - Charleston
    • West Columbia, South Carolina, United States, 29169
      • Palmetto Retina Center - West Columbia
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Regional Eye Institute
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Charles Retina Specialists - Germantown
    • Nashville, Tennessee, United States, 37212-1610
      • Vanderbilt University Medical School
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Retina Associates - Central
    • Fort Worth, Texas, United States, 76104
      • Texas Retina Associates - Fort Worth
    • San Antonio, Texas, United States, 78240
      • Medical Center Ophthalmology Associates - Northwest
    • San Antonio, Texas, United States, 78240
      • Retina Consultants of Texas - San Antonio Medical Center
    • The Woodlands, Texas, United States, 77384
      • Retina Consultants of Texas - The Woodlands
    • The Woodlands, Texas, United States, 77384
      • Retina Consultants of Texas (Retina Consultants of Houston) - Texas Medical Center
  • Vermont
    • Burlington, Vermont, United States, 05401-1473
      • The University of Vermont Medical Center (Fletcher Allen Health Care) - Main Campus
  • Washington
    • Spokane, Washington, United States, 99204
      • Spokane Eye Clinical Research
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • West Virginia University
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin - Madison

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Active subfoveal CNV secondary to nAMD, including juxtafoveal lesions that affect the fovea as assessed in the study eye.
• Total area of CNV (including both classic and occult components) must comprise greater than 50% of the total lesion area in the study eye.
• BCVA ETDRS letter score of 78 to 24 (corresponding to a Snellen equivalent of approximately 20/32 to 20/320) in the study eye.
• Decrease in BCVA determined to be primarily the result of nAMD in the study eye.
• Presence of IRF and/or SRF affecting the central subfield of the study eye on OCT.
• Contraceptive use by men or women should be consistent with local regulations regarding the methods of highly effective contraception for those participating in clinical studies.
• Other protocol-specified inclusion criteria.

Additional inclusion criteria for Year 3:

• At least one BCVA value and one central subfield retinal thickness (CST) value from measurements at one of the following visits: Visit 24 (Week 84), Visit 25 (Week 88) or Visit 26 (Week 92).
• Participant is enrolled at a site that participates in the extension period.

Exclusion Criteria:

• Causes of CNV other than nAMD in the study eye.
• Scar, fibrosis, or atrophy involving the central subfield in the study eye.
• Presence of retinal pigment epithelial tears or rips involving the central subfield in the study eye.
• Uncontrolled glaucoma (defined as IOP >25 mmHg despite treatment with anti-glaucoma medication) in the study eye.
• History of idiopathic or autoimmune uveitis in the study eye.
• Myopia of a spherical equivalent of at least 8 diopters in the study eye prior to any refractive or cataract surgery.
• History or clinical evidence of diabetic retinopathy, diabetic macular edema, or any retinal vascular disease other than nAMD in either eye.
• Evidence of extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening/randomization.
• Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg).
• Any prior or concomitant ocular (in the study eye) or systemic treatment (with an investigational or approved, anti-VEGF or other agent) or surgery for nAMD, except dietary supplements or vitamins.
• Other protocol-specified exclusion criteria

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aflibercept 2q8; In the double-masked study part (Years 1 and 2), Aflibercept 2 mg administered every 8 weeks after a loading phase. (Active Comparator) In Year 3, high dose aflibercept administered according to individual patient response. (Experimental)	Drug: Aflibercept High Dose VEGF Trap-Eye (BAY86-5321); Solution in Vial, intravitreal (IVT) injection; Drug: Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321); Solution in Vial, 2 mg, intravitreal (IVT) injection
Experimental: Aflibercept HDq12; Aflibercept high dose (HD) administered every 12 weeks after an initiation phase. Treatment intervals adjusted according to individual patient response.	Drug: Aflibercept High Dose VEGF Trap-Eye (BAY86-5321); Solution in Vial, intravitreal (IVT) injection
Experimental: Aflibercept HDq16; Aflibercept high dose administered every 16 weeks after an initiation phase. Treatment intervals adjusted according to individual patient response.	Drug: Aflibercept High Dose VEGF Trap-Eye (BAY86-5321); Solution in Vial, intravitreal (IVT) injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 48	Visual function of the study eye was assessed at a distance of 4 meters using the ETDRS BCVA letter score. BCVA scale range is 0 (worst) to 100 (best).	At baseline and Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With no Intraretinal Fluid (IRF) and no Subretinal Fluid (SRF) in Central Subfield at Week 16		At Week 16
Percentage of Participants Gaining at Least 15 Letters in BCVA From Baseline at Week 48		At baseline and Week 48
Percentage of Participants Achieving an ETDRS Letter Score of at Least 69 (Approximate 20/40 Snellen Equivalent) at Week 48		At Week 48
Change in Choroidal Neovascularization (CNV) Size From Baseline to Week 48		At baseline and Week 48
Change in Total Lesion Area From Baseline to Week 48		At baseline and Week 48
Percentage of Participants With no Intraretinal Fluid (IRF) and no Subretinal Fluid (SRF) in the Center Subfield at Week 48		At Week 48
Change From Baseline in Central Subfield Retinal Thickness (CST) at Week 48		At baseline and Week 48
Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Total Score at Week 48	NEI VFQ-25 was a 25-item questionnaire that gave a score on a scale from 0 (worst) to 100 (best = no vision problems)	At baseline and Week 48
Systemic Exposure to Aflibercept as Assessed by Plasma Concentrations of Free, Adjusted Bound and Total Aflibercept From Baseline Through Week 48		Up to Week 48
Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 60	Visual function of the study eye was assessed at a distance of 4 meters using the ETDRS BCVA letter score. BCVA scale range is 0 (worst) to 100 (best).	At baseline and Week 60
Incidence of Treatment-emergent Anti-drug Antibodies (ADA) Response		Up to week 96

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Regeneron Pharmaceuticals

Publications and helpful links

General Publications

• Lanzetta P, Korobelnik JF, Heier JS, Leal S, Holz FG, Clark WL, Eichenbaum D, Iida T, Xiaodong S, Berliner AJ, Schulze A, Schmelter T, Schmidt-Ott U, Zhang X, Vitti R, Chu KW, Reed K, Rao R, Bhore R, Cheng Y, Sun W, Hirshberg B, Yancopoulos GD, Wong TY; PULSAR Investigators. Intravitreal aflibercept 8 mg in neovascular age-related macular degeneration (PULSAR): 48-week results from a randomised, double-masked, non-inferiority, phase 3 trial. Lancet. 2024 Mar 23;403(10432):1141-1152. doi: 10.1016/S0140-6736(24)00063-1. Epub 2024 Mar 7.

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2020
• Primary Completion (Actual): July 27, 2022
• Study Completion (Actual): August 7, 2024

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: nAMD
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Wet Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; aflibercept
• Other Study ID Numbers: 20968; 2019-003851-12 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes