do_not_disturb_altRecruitment Complete

Neovascular Age-Related Macular Degeneration

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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

50 - N/A
  • - 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.
  • - 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

Trial summary

Enrollment Goal
1011
Trial Dates
August 2020 - August 2024
Phase
Phase 3
Could I Receive a placebo
No
Products
Aflibercept (VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Kobe University HospitalKobe, 650-0017, Japan
Completed
Hyogo Prefectural Amagasaki General Medical CenterAmagasaki, 660-8550, Japan
Completed
Nagoya City University HospitalNagoya, 467-8602, Japan
Completed
University of the Ryukyus HospitalNakagami, 903-0215, Japan
Withdrawn
Universitätsklinikum AachenAachen, 52074, Germany
Withdrawn
Universitätsmedizin der Georg-August-Universität GöttingenGöttingen, 37075, Germany
Withdrawn
Klinikum DarmstadtDarmstadt, 64297, Germany
Withdrawn
Medizinische Hochschule Hannover (MHH)Hannover, 30625, Germany
Withdrawn
Universitätsklinikum Leipzig AöRLeipzig, 4289, Germany
Withdrawn
Augenzentrum am St. Franziskus-HospitalMünster, 48145, Germany
Withdrawn
Medizinische Einrichtungen der Universität BonnBonn, 53105, Germany
Withdrawn
Hopital Avicenne - BobignyBOBIGNY, 93009, France
Completed
AXON Clinical s.r.o.Praha 5, 150 00, Czech Republic
Completed
Fakultni nemocnice OstravaOstrava, 708 52, Czech Republic
Completed
Fakultni Nemocnice Hradec KraloveHradec Kralove, 500 05, Czech Republic
Completed
Charles University in PraguePrague, 110 00, Czech Republic
Completed
Sydney Retina ClinicSydney, 2000, Australia
Completed
Marsden Eye Surgery CenterParramatta, 2150, Australia
Completed
Westmead HospitalWestmead, 2145, Australia
Completed
Eyeclinic Albury WodongaAlbury, 2640, Australia
Completed
Hobart Eye SurgeonsHobart, 7000, Australia
Withdrawn
Hong Kong Eye HospitalHong Kong, Hong Kong
Withdrawn
Queen Mary HospitalHong Kong, Hong Kong
Completed
Klinikum Klagenfurt am WörtherseeKlagenfurt, 9020, Austria
Completed
Pusan National University HospitalBusan, 49241, Korea,_republic_of
Completed
Asan Medical CenterSeoul, 138-736, Korea,_republic_of
Completed
Samsung Medical CenterSeoul, 6351, Korea,_republic_of
Completed
Seoul National University Hospital (b)Seoul, 03080, Korea,_republic_of
Completed
Seoul National University Bundang HospitalSeongnam-si, 13620, Korea,_republic_of
Completed
Samsung Medical CenterSeoul, 6351, Korea,_republic_of
Withdrawn
Moorfields Eye HospitalLondon, EC1V2PD, United Kingdom
Withdrawn
Frimley Park Hospital NHSFrimley, GU167UJ, United Kingdom
Withdrawn
Bristol Eye HospitalBristol, BS12LX, United Kingdom
Withdrawn
Sunderland Eye InfirmarySunderland, SR29HP, United Kingdom
Completed
New England Retina AssociatesNew London, 06320, United States
Completed
Ophthalmic Consultants of Boston (OCB) - BostonBoston, 02114-2539, United States
Completed
Palmetto Retina Center (PRC)- West Columbia Retina CenterWest Columbia, 29169-2429, United States
Withdrawn
Gulf Coast Institute / Valley Retina InstituteMcAllen, 78503, United States
Completed
Medical Center Ophthalmology AssociatesSan Antonio, 78240, United States
Completed
Hayashi Eye HospitalFukuoka, 812-0011, Japan
Withdrawn
Shiga University of Medical Science HospitalOtsu, 520-2192, Japan
Completed
Daiyukai Daiichi HospitalIchinomiya, 491-8551, Japan
Withdrawn
Aomori Prefectural Central HospitalAomori, 030-8553, Japan
Withdrawn
Sugita Eye HospitalNagoya, 460-0008, Japan
Completed
National Hospital Organization Tokyo Medical CenterMeguro-ku, 152-8902, Japan
Completed
Fakultna nemocnica TrencinTrencin, 911 71, Slovakia
Completed
Stadtspital TriemliZürich, 8063, Switzerland
Active, not recruiting
Chang Gung Memorial Hospital at LinkouTaoyuan, 33305, Taiwan
Active, not recruiting
Shin Kong Wu Ho-Su Memorial HospitalTaipei, 111, Taiwan
Withdrawn
Veterans General HospitalKaohsiung City, 813414, Taiwan
Active, not recruiting
National University HospitalSingapore, 119074, Singapore
Completed
Organizacion Medica de Investigacion (OMI)Buenos Aires, C1015ABO, Argentina
Withdrawn
Fundación ZambranoBuenos Aires, C1023AAQ, Argentina
Active, not recruiting
Konventhospital Barmherzige Brüder LinzLinz, 4021, Austria
Completed
Hanusch-Krankenhaus WienWien, 1140, Austria
Completed
Mie University HospitalTsu, 514-8507, Japan
Completed
Akita University HospitalAkita, 010-8543, Japan
Completed
Nagoya University HospitalNagoya, 466-8560, Japan
Completed
Kansai Medical University HospitalHirakata, 573-1191, Japan
Completed
Hiroshima University HospitalHiroshima, 734-8551, Japan
Withdrawn
Hacettepe Universitesi Tip FakultesiAnkara, 6100, Turkey
Withdrawn
OogziekenhuisROTTERDAM, 3011 BH, Netherlands
Withdrawn
Region Nordjylland | Aalborg University Hospital - Cardiology DepartmentAalborg, 9000, Denmark
Withdrawn
Copenhagen University Hospital RoskildeRoskilde, 4000, Denmark
Withdrawn
Hospital de Vila Franca de Xira | Centro de Desenvolvimento e InvestigacaoVila Franca de Xira, 2600-178, Portugal
Completed
AIBILICoimbra, 3000-548, Portugal
Active, not recruiting
Oita University HospitalYufu, 879-5593, Japan
Withdrawn
National Taiwan University HospitalTaipei, 100, Taiwan
Active, not recruiting
Taipei Veterans General HospitalTaipei, 11217, Taiwan
Completed
Fukushima Medical University HospitalFukushima, 960-1295, Japan
Completed
Okayama University HospitalOkayama-city, 700-8558, Japan
Completed
Kurume University HospitalKurume, 830-0011, Japan
Completed
Yamaguchi University HospitalUbe, 755-8505, Japan
Completed
Kanazawa University HospitalKanazawa, 920-8641, Japan
Completed
Fakultni nemocnice Kralovske VinohradyPraha 10, 10034, Czech Republic
Withdrawn
Changhua Christian HospitalChanghua, 50006, Taiwan
Withdrawn
Juntendo University Urayasu HospitalUrayasu, 279-0021, Japan
Withdrawn
Kochi Medical School HospitalNankoku, 783-8505, Japan
Completed
Hospital of LT University of Health Sciences Kaunas ClinicsKaunas, LT-50161, Lithuania
Completed
Vilnius University Hospital Santaros KlinikosVilnius, LT-08661, Lithuania
Completed
PI Klaipedos University HospitalKlaipeda, LT-92288, Lithuania
Withdrawn
Dr. Kai Noor Silmakabinet OUTallinn, 11412, Estonia
Completed
East Tallinn Central HospitalTallinn, 10138, Estonia
Completed
Latvian American Eye CenterRiga, LV-1009, Latvia
Completed
Department of OphthalmologyRiga, 1002, Latvia
Withdrawn
Universitätsklinik Gießen und Marburg GmbHMarburg, 35043, Germany
Withdrawn
Sankt Gertrauden KrankenhausBerlin, 10713, Germany
Withdrawn
Universitätsklinikum FreiburgFreiburg, 79106, Germany
Withdrawn
Universitätsklinikum KölnKöln, 50937, Germany
Withdrawn
Charité Campus Benjamin Franklin (CBF)Berlin, 12203, Germany
Withdrawn
Universitätsklinikum Schleswig-Holstein (UKSH)Kiel, 24105, Germany
Withdrawn
Universitätsklinikum RegensburgRegensburg, 93042, Germany
Completed
Long Island Vitreoretinal ConsultantsGreat Neck, 11021, United States
Active, not recruiting
Ophthalmic Consultants of Long IslandLynbrook, 11563, United States
Completed
Long Island Vitreoretinal Consultants - HauppaugeHauppauge, 11788, United States
Completed
NJ Retina - Edison OfficeEdison, 08820, United States
Completed
Texas Retina AssociatesFort Worth, 76104, United States
Completed
Retina Northwest, PC - OpthalmologyPortland, 97210, United States
Completed
Retina Care CenterBaltimore, 21209, United States
Completed
Retina Consultants of NevadaLas Vegas, 89144, United States
Completed
Retina Center of New JerseyBloomfield, 07003, United States
Completed
Retina Vitreous Associates of Florida - Saint PetersburgSaint Petersburg, 33711-1141, United States
Completed
West Virginia UniversityMorgantown, 26505, United States
Completed
Spokane Eye Clinical ResearchSpokane, 99204, United States
Completed
Arizona Retina and Vitreous Consultants - North PhoenixPhoenix, 85021-8865, United States
Completed
Florida Retina Institute- Jacksonville OakJacksonville, 32204-4505, United States
Completed
California Eye Specialists Medical Group, Inc.Pasadena, 91107, United States
Completed
Retinal Consultants of Texas - San AntonioSan Antonio, 78240, United States
Completed
Mid Atlantic RetinaBethlehem, 18017, United States
Completed
Retina Consultants of Texas - The WoodlandsThe Woodlands, 77384, United States
Completed
Charles Retina InstituteMemphis, 38119, United States
Completed
Retina Consultants of Texas (Retina Consultants of Houston) - Texas Medical CenterThe Woodlands, 77384, United States
Completed
Vitreo Retinal Surgery PA - EdinaEdina, 55435, United States
Completed
Retina Consultants San DiegoPoway, 92064, United States
Completed
University Retina and Macula AssociatesOak Forest, 60452, United States
Completed
Florida Retina InstituteOrlando, 32806, United States
Completed
Southern Vitreoretinal Associates, P.L. - TallahasseeTallahassee, 32308, United States
Completed
Vitreo Retinal Associates PA - The Millennium Center LocationGainesville, 32607-2557, United States
Active, not recruiting
Retina Group of Florida - Fort LauderdaleFort Lauderdale, 33308, United States
Completed
Vanderbilt University Medical SchoolNashville, 37212-1610, United States
Completed
Eye Associates of New MexicoAlbuquerque, 87109-5853, United States
Completed
Black Hills Regional Eye InstituteRapid City, 57701-7374, United States
Completed
Eye Care SpecialistsKingston, 18704, United States
Completed
Northern California Retina-Vitreous AssociatesMountain View, 94040, United States
Completed
Charleston Neuroscience Institute - CharlestonCharleston, 29414, United States
Withdrawn
UCLA - Jules Stein Eye InstituteLos Angeles, 90095, United States
Withdrawn
Mayo Clinic - RochesterRochester, 55905, United States
Completed
Retina Macula Specialists Of MiamiMiami, 33126, United States
Withdrawn
University of Virginia Health SystemCharlottesville, 22903, United States
Completed
Midwest Retina - Main OfficeDublin, 43016, United States
Withdrawn
Retina Institute of VirginiaRichmond, 23235, United States
Withdrawn
Illinois Retina Associates, S.C.Skokie, 60076, United States
Completed
Retina Consultants of HawaiiAiea, 96701, United States
Completed
The University of Vermont Medical Center (Fletcher Allen Health Care) - Main CampusBurlington, 05401-1473, United States
Completed
Retina Associates ILElmhurst, 60126, United States
Completed
Florida Eye AssociatesMelbourne, 32901, United States
Withdrawn
Palmetto Retina Center, LLC - FlorenceFlorence, 29501, United States
Active, not recruiting
Erie Retinal Surgery, Inc.Erie, 16507, United States
Completed
Austin Retina AssociatesAustin, 78705, United States
Completed
Retina Consultants of Southern CaliforniaRedlands, 92374, United States
Completed
University of Wisconsin - MadisonMadison, 53792, United States
Active, not recruiting
Wake Forest Baptist HealthWinston-Salem, 27103, United States
Completed
University of California San Diego (UCSD)La Jolla, 92093, United States
Completed
Retina SpecialistsPensacola, 32503, United States
Completed
Retina Consultants of Orange CountyFullerton, 92835, United States
Active, not recruiting
Ophthalmic Consultants of the Capital RegionTroy, 12180, United States
Completed
Retina Consultants, LLCSalem, 97302-2152, United States
Completed
Kaiser Permanente Riverside Medical CenterRiverside, 92505, United States
Completed
Kozawa Eye Hospital and Diabetes CenterMito, 310-0845, Japan
Withdrawn
Tohoku Medical and Pharmaceutical University Hospital | Center for Clinical Research Promotion and DevelopmentSendai-city, 983-8512, Japan
Completed
The University of Tokyo HospitalBunkyo-ku, 113-8655, Japan
Completed
Kansai Medical University Medical CenterMoriguchi, 570-8507, Japan
Completed
Kindai University HospitalOsakasayama-shi, 589-8511, Japan
Completed
Aichi Medical University HospitalNagakute, 480-1195, Japan
Withdrawn
Oogartsenpraktijk AlkenAlken, 3570, Belgium
Completed
Lexum a.s., Evropska ocni klinikaPraha 4, 140 00, Czech Republic
Completed
Fakultni nemocnice Plzen - LochotinPlzen-Lochotin, 323 00, Czech Republic
Completed
Szent-Gyorgyi Albert Orvostudomanyi EgyetemSzeged, 6720, Hungary
Withdrawn
Clínica Oftalmológica San DiegoMedellín, Colombia
Withdrawn
Clínica Imbanaco S.A.SCali, 760042, Colombia
Completed
Tartu University HospitalTartu, 50406, Estonia
Completed
Riga East Clinical University Hospital "Gailezers"Riga, LV-1038, Latvia
Withdrawn
Signes Ozolinas Doctor Praxis in OphthalmologyJelgava, LV-3001, Latvia
Completed
Shinshu University HospitalMatsumoto, 390-8621, Japan
Active, not recruiting
Japanese Red Cross Saitama HospitalSaitama, 330-8553, Japan
Completed
Kokura Memorial HospitalKitakyushu, 802-8555, Japan
Completed
Japanese Red Cross Nagasaki Genbaku HospitalNagasaki, 852-8511, Japan
Completed
Japanese Red Cross Wakayama Medical centerWakayama, 640-9558, Japan
Withdrawn
Hospital of St. CrossRugby, CV22 5PX, United Kingdom
Withdrawn
Ideta Heisei Retina ConsultantsKumamoto, 862-0968, Japan
Completed
Singapore National Eye CentreSingapore, 168751, Singapore
Withdrawn
Tan Tock Seng HospitalSingapore, 308433, Singapore
Completed
University of Miyazaki HospitalMiyazaki, 889-1692, Japan
Completed
Keio University HospitalShinjuku-ku, 160-8582, Japan
Withdrawn
Sumitomo HospitalOsaka, 530-0005, Japan
Withdrawn
Ophthalmology Clinic of Professor SergienkoVinnitsya, Ukraine
Withdrawn
Kharkiv Ophthalmological Clinic #14 named by HirshmanKharkiv, 61000, Ukraine
Completed
Poltava Regional Clinical Hospital n.a. M.V. SkliphosovskyiPoltava, 36011, Ukraine
Completed
Centralna Polyclinica MVS UkraiinyKyiv, 1024, Ukraine
Withdrawn
Health Technology Ltd. - Ophthalmic Medical CenterOdesa, 65048, Ukraine
Withdrawn
A.S.U. Giuliano IsontinaTrieste, 34129, Italy
Withdrawn
A.O.U. di Bologna Policlinico S.Orsola MalpighiBologna, 40138, Italy
Completed
Ospedale San Raffaele s.r.l. - OculisticaMilano, 20132, Italy
Withdrawn
ASL2 Lanciano-Vasto-ChietiChieti, 66013, Italy
Completed
Fondazione PTV Policlinico Tor VergataRoma, 00133, Italy
Completed
IRCCS Fondazione G.B. Bietti Studio e Ricerca in OtalmologiaRoma, 198, Italy
Completed
A.O. di PerugiaPerugia, 6129, Italy
Withdrawn
A.O.U. Policlinico G.Rodolico-San MarcoCatania, 95123, Italy
Active, not recruiting
A.O.U. di CagliariCagliari, 9042, Italy
Withdrawn
A.O.U. di PadovaPadova, 35128, Italy
Withdrawn
Fakultni Nemocnice BrnoBrno, 625 00, Czech Republic
Completed
ALM Oftalmolaser - Oftalmologia Medica e CirurgicaLisbon, 1050-078, Portugal
Completed
Centro Hospitalar Universitario do PortoPorto, 4099-001, Portugal
Completed
Centro Hospitalar Vila Nova de Gaia e Espinho | Unit 1 - Clinical Research CenterPorto, 4434-502, Portugal
Withdrawn
Centro Hospitalar de Leiria | Santo Andre Hospital - Research CenterLeiria, 2410-197, Portugal
Withdrawn
ULSAM - Hospital Santa LuziaViana do Castelo, 4901-858, Portugal
Withdrawn
CHLC - Hospital dos Capuchos - Servico de OftalmologiaLisboa, 1169-050, Portugal
Completed
Fakultna nemocnica s poliklinikou ZilinaZilina, 012 07, Slovakia
Completed
Fakultna nemocnica NitraNitra, 950 01, Slovakia
Completed
Nemocnica s Poliklinikou Trebisov, Svet zdravia a.s.Trebisov, 075 01, Slovakia
Completed
University of Yamanashi HospitalChuo, 409-3898, Japan
Withdrawn
Dokkyo Medical University Saitama Medical CenterKoshigaya, 343-8555, Japan
Active, not recruiting
Kanazawa Medical University HospitalKahoku-gun, 920-0293, Japan
Completed
Otakeganka Tsukimino ClinicYamato, 242-0001, Japan
Withdrawn
Osaka Metropolitan University HospitalOsaka, 545-8586, Japan
Completed
Kagawa University HospitalKita-gun, 761-0793, Japan
Completed
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, 00168, Italy
Completed
ASST Fatebenefratelli SaccoMilano, 20122, Italy
Completed
Nara Medical University HospitalKashihara, 634-8522, Japan
Completed
Tokushima University HospitalTokushima, 770-8503, Japan
Completed
Gunma University HospitalMaebashi, 371-8511, Japan
Withdrawn
Chofu Eye ClinicChofu, 182-0024, Japan
Completed
Medical corporation Eiwakai Dannoue Ophthalmology clinicKawasaki, 211-0053, Japan
Withdrawn
Dokkyo Medical University HospitalShimotsuga-gun, 321-0293, Japan
Withdrawn
Yamanashi Prefectural Central HospitalKofu, 400-8506, Japan
Completed
Tokiwadai Muranaka Eye ClinicItabashi-ku, 174-0071, Japan
Completed
Kurashiki Medical CenterKurashiki, 710-8522, Japan
Withdrawn
Fundacion Ver Centro privado de Ojos Romagosa SACórdoba, 5000, Argentina
Withdrawn
Grupo Laser VisionRosario, S2000ANJ, Argentina
Withdrawn
Centro Oftalmologico Miramar (COMir)Miramar, B7607AKL, Argentina
Withdrawn
Clínia Panamericana - Centro de Ojos Dr. NanoOlivos, B1636CSS, Argentina
Completed
Medizinische Universität GrazGraz, 8036, Austria
Withdrawn
Universitätsklinikum AKH WienWien, 1090, Austria
Active, not recruiting
Kepler Universitätsklinikum Campus IIILinz, 4020, Austria
Completed
Hospital de la Santa Creu i Sant Pau | Gynecology DepartmentBarcelona, 8041, Spain
Withdrawn
Hospital del Rio HortegaValladolid, 47012, Spain
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 8036, Spain
Completed
Hospital Reina SofíaCórdoba, 14004, Spain
Withdrawn
Vissum Corporacion AlicanteAlicante, 03016, Spain
Completed
Hospital Miguel ServetZaragoza, 50009, Spain
Completed
Hospital General Universitario de ValenciaValencia, 46014, Spain
Withdrawn
Hospital de l'EsperançaBarcelona, 8024, Spain
Completed
Instituto Oftalmológico Francisco Gomez UllaSantiago de Compostela, 15706, Spain
Completed
La Fe University and Polytechnic Hospital | Nephrology DepartmentValencia, 46026, Spain
Active, not recruiting
Meir Medical CenterKfar Saba, 4428164, Israel
Completed
Chaim Sheba Medical CenterRamat Gan, 5262000, Israel
Completed
Assuta Medical Centers - HaShalomTel Aviv, 6789140, Israel
Withdrawn
Shamir Medical Center (Assaf Harofeh)Zerifin, 7030000, Israel
Withdrawn
Barzilai Medical CenterAshkelon, 7830604, Israel
Completed
Lady Davis Carmel Medical CenterHaifa, 3436212, Israel
Withdrawn
Rabin Medical Center | Beilinson Hospital - Internal Medicine C DepartmentPetach Tikva, 4941492, Israel
Completed
Rambam Health CorporationHaifa, 3109601, Israel
Active, not recruiting
Kaplan Medical CenterRehovot, 7610001, Israel
Withdrawn
Tel-Aviv Sourasky Medical CenterTel Aviv, 6423906, Israel
Withdrawn
HaEmek Medical Center | Internal Medicine C Department - Research UnitAfula, 1834111, Israel
Withdrawn
Clalit Health | Soroka Medical Center - Internal Medicine DepartmentBeer Sheva, 8410101, Israel
Withdrawn
Bnai Zion Medical Center | Cardiology DepartmentHaifa, 3339419, Israel
Withdrawn
Shaare Zedek Medical CenterJerusalem, 9103102, Israel
Completed
Hadassah Hebrew University Hospital Ein KeremJerusalem, 9112001, Israel
Completed
RétinElyséeLausanne, 1006, Switzerland
Completed
Berner Augenklinik am LindenhofspitalBern, TBC, Switzerland
Withdrawn
Universitätsspital BaselBasel, 4056, Switzerland
Withdrawn
Stadtspital TriemliZürich, 8063, Switzerland
Withdrawn
Centre Ophtalmologique de RiveGenève, 1204, Switzerland
Active, not recruiting
Inje University Haeundae Paik HospitalBusan, 612-862, Korea,_republic_of
Completed
Nune Eye Hospital - Retina Center OphthalmologySeoul, 135-280, Korea,_republic_of
Completed
SEHAT PentagramSofia, 1309, Bulgaria
Completed
Sveta Petka Eye HospitalVarna, 9000, Bulgaria
Completed
Multiprofile Hospital for Active Treatment Sveta Sofia | Internal Diseases DepartmentSofia, 1618, Bulgaria
Completed
UMHAT Alexandrovska EADSofia, 1431, Bulgaria
Completed
Specialized Hospital For Active Treatment of Eye Diseases ZoraSofia, 1784, Bulgaria
Completed
Spec. Hosp. for Active Treatment for Eye Diseases ZrenieSofia, 1408, Bulgaria
Withdrawn
University Eye Hospital - Akad. PashevSofia, 1517, Bulgaria
Completed
St.Joseph's Health Care-LondonLondon, N6A 4V2, Canada
Completed
Toronto Retina InstituteToronto, M3C 0G9, Canada
Active, not recruiting
Institut de l'Oeil des LaurentidesBoisbriand, J7H1S6, Canada
Withdrawn
Misericordia Health CentreWinnipeg, R3C 1A2, Canada
Completed
Scientific Research Institution of Ophthalmic DiseasesMoscow, 119021, Russia
Completed
FBSI IRTC Eye Microsurgery n.a. acad. S.N. FyodorovMoscow, 127486, Russia
Withdrawn
St. Petersburg Medical University n.a. I.P. PavlovSt. Petersburg, 197022, Russian Federation
Withdrawn
Regional Ophthalmological Hospital n. a. T.I. EroshevskySamara, 443079, Russia
Withdrawn
Irkutsk Branch of FBSI IRTC "Eye Microsurgery"Irkutsk, 664033, Russia
Completed
Southern Tohoku Eye ClinicKoriyama, 963-8052, Japan
Withdrawn
Clinical Center NisNis, 18000, Serbia
Active, not recruiting
Clinical hospital center ZvezdaraBelgrade, 11000, Serbia
Completed
Clinical Center of SerbiaBelgrade, 11000, Serbia
Active, not recruiting
Klinicki centar VojvodineNovi Sad, 21000, Serbia
Completed
St.Luke's International HospitalChuoku, 104-8560, Japan
Completed
LTD "Innova"Tbilisi, 105, Georgia
Completed
LTD "Chichua Medical Center MZERA"Tbilisi, 114, Georgia
Withdrawn
Aversi ClinicTbilisi, Georgia
Completed
JSC "Evex Hospitals'Tbilisi, 0186, Georgia
Withdrawn
LTD Israeli-Georgian Medical Research Clinic “Helsicore”Tbilisi, 112, Georgia
Completed
LTD "Clinic LJ" - OpthalmologyKutaisi, 4600, Georgia
Completed
Tokyo Women's Medical University HospitalShinjuku-ku, 162-8666, Japan
Active, not recruiting
Yamagata University HospitalYamagata, 990-9585, Japan
Withdrawn
Kurashiki Medical ClinicKurashiki, 710-0824, Japan
Active, not recruiting
Sapporo City General HospitalSapporo, 060-8604, Japan
Completed
Nishikasai Inouye Eye HospitalEdogawa-ku, 134-0088, Japan
Withdrawn
John Radcliffe HospitalOxford, OX3 9DU, United Kingdom
Withdrawn
Western Eye HospitalLondon, NW1 5QH, United Kingdom
Withdrawn
Royal Victoria HospitalBelfast, BT12 6BA, United Kingdom
Completed
Shanghai General HospitalShanghai, 200080, China
Completed
Tianjin Eye HospitalTianjin, 300384, China
Completed
The Affiliated Eye Hospital of Wenzhou Medical CollegeWenzhou, China
Withdrawn
Peking Union Medical College Hospital CAMSBeijing, 100730, China
Completed
Peking University People's HospitalBeijing, 100032, China
Active, not recruiting
Tianjin Medical University Eye HospitalTianjin, 300384, China
Completed
Retina Consultants of Southern Colorado, PCColorado Springs, 80909, United States
Completed
Wolfe Eye Clinic - Des MoinesWest Des Moines, 50266-7705, United States
Withdrawn
Retina Associates, P.A. - Shawnee MissionOverland Park, 66204-2235, United States
Withdrawn
Oftalmólogos especialistasRosario, S2000ANJ, Argentina
Completed
OFTALMOS, Instituto Oftalmologico de Alta ComplejidadBuenos Aires, C1120AAN, Argentina
Completed
Tokyo Medical University Hachioji Medical CenterHachioji, 193-0998, Japan
Completed
KKR Sapporo Medical CenterSapporo, 062-0931, Japan
Completed
Espaco Medico de CoimbraCoimbra, 3000-548, Portugal
Completed
St. Marianna University HospitalKawasaki, 216-8511, Japan
Completed
Guangzhou Aier Eye HospitalGuangzhou, 634050, China
Completed
Centre d'Ophtalmologie - Paradis-MonticelliMARSEILLE, 13008, France
Completed
Centre ophtalmologique Saint-ExupérySaint-Cyr-Sur-Loire, 37540, France
Completed
Private enterprise private production company " Acinus"Kropyvnytskyi, 25006, Ukraine
Completed
Union Hospt Tongji Medical Colleg. Huazhong univ. Scien&TechWuhan, 430030, China
Completed
Henan Provincial Eye HospitalHenan, 450008, China
Active, not recruiting
The First Affiliated Hospital of Xinjiang Medical UniversityUrumchi, MISSING, China
Completed
Beijing HospitalBeijing, 100730, China
Completed
Eye Center of the second Bethune Hospital, jinlin UniversityChangchun, 130022, China
Completed
Tianjin Medical University General HospitalTianjin, 300052, China
Completed
Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.Wuhan, 430030, China
Completed
People's Hospital of Ningxia Hui Autonomous Region - OpthalmologyNingxia, 750002, China
Completed
Beijing Aier Intech Eye HospitalBeijing, 100000, China
Completed
Aier Eye Hospital (Chengdu)Chengdu, N/A, China
Completed
Shenyang He Eye Specialist HospitalShenyang, 110034, China
Completed
ZheJiang Provincial People's HospitalHangzhou, 310014, China
Completed
The 1st Affiliated Hospital of Zhejiang UniversityHangzhou, 310000, China
Completed
The 1st Affiliated Hospital Fujian Medical UniversityFuzhou, TBC, China
Completed
Chongqing Aier Ophthalmology HospitalChongqing, 400020, China
Completed
Beijing Tongren Hospital, Capital Medical University (East)Beijing, 100005, China
Completed
The Second Hospital of Anhui medical universityHefei, 230601, China
Completed
The First People's Hospital of XuzhouXuzhou, 221002, China
Completed
Hebei eye hospitalHebei, 050010, China
Completed
Jiangxi Provincial People’s HospitalNanchang, 330006, China
Completed
The First Affiliated Hospital of NanChang UniversityNanchang, 330006, China
Completed
The First Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, 710061, China
Completed
Shanghai Tongji Hospital of Tongji UniversityShanghai, TBC, China
Completed
Tonghua Central HospitalTonghua, 134001, China
Completed
Shijiazhuang General HospitalShijiazhuang, 50000, China
Active, not recruiting
Hôpital Lariboisière - ParisPARIS, 75475, France
Active, not recruiting
Budapest Retina AssociatesBudapest, 1133, Hungary
Completed
Rand Eye InstituteDeerfield Beach, 33064, United States

Primary Outcome

  • Change from baseline in BCVA measured by the ETDRS letter score at Week 48
    date_rangeTime Frame:
    At baseline and Week 48

Secondary Outcome

  • Change from baseline in BCVA measured by the ETDRS letter score at Week 60
    date_rangeTime Frame:
    At baseline and Week 60
  • Proportion of participants with no intraretinal fluid (IRF) and no subretinal fluid (SRF) in central subfield at Week 16
    date_rangeTime Frame:
    At Week 16
  • Proportion of participants gaining at least 15 letters in BCVA from baseline at Week 48
    date_rangeTime Frame:
    At baseline and Week 48
  • Proportion of participants achieving an ETDRS letter score of at least 69 (approximate 20/40 Snellen equivalent) at Week 48
    date_rangeTime Frame:
    At Week 48
  • Change in choroidal neovascularization (CNV) size from baseline to Week 48
    date_rangeTime Frame:
    At baseline and Week 48
  • Change in total lesion area from baseline to Week 48
    date_rangeTime Frame:
    At baseline and Week 48
  • Proportion of participants with no IRF and no SRF in the center subfield at Week 48
    date_rangeTime Frame:
    At Week 48
  • Change from baseline in central subfield retinal thickness (CST) at Week 48
    date_rangeTime Frame:
    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)
    date_rangeTime Frame:
    At baseline and Week 48
  • Number of participants with treatment-emergent adverse events (TEAEs) and serious AEs (SAEs)
    date_rangeTime Frame:
    Up to 156 weeks
  • Systemic exposure to aflibercept as assessed by plasma concentrations of free, adjusted bound and total aflibercept from baseline through Week 48
    date_rangeTime Frame:
    Up to Week 48
  • Assessment of immunogenicity to aflibercept by measuring the incidence of treatment-emergent anti-drug antibodies (ADA) response through end of masked study
    date_rangeTime Frame:
    Up to week 96

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
3