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
NCT ID: NCT04423718
Last Updated: 2025-08-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1011 participants
INTERVENTIONAL
2020-08-11
2024-08-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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)
Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)
Solution in Vial, intravitreal (IVT) injection
Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321)
Solution in Vial, 2 mg, intravitreal (IVT) injection
Aflibercept HDq12
Aflibercept high dose (HD) administered every 12 weeks after an initiation phase. Treatment intervals adjusted according to individual patient response.
Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)
Solution in Vial, intravitreal (IVT) injection
Aflibercept HDq16
Aflibercept high dose administered every 16 weeks after an initiation phase. Treatment intervals adjusted according to individual patient response.
Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)
Solution in Vial, intravitreal (IVT) injection
Interventions
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Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)
Solution in Vial, intravitreal (IVT) injection
Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321)
Solution in Vial, 2 mg, intravitreal (IVT) injection
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
* 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.
50 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Locations
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Arizona Retina & Vitreous Consultants - Central Phoenix Phoenix
Phoenix, Arizona, United States
Retina Consultants of Orange County - Fullerton
Fullerton, California, United States
Northern California Retina Vitreous Associates - Mountain View Office
Mountain View, California, United States
Azul Vision Pasadena
Pasadena, California, United States
Retina Consultants San Diego - Poway
Poway, California, United States
Retina Consultants of Southern California
Redlands, California, United States
Kaiser Permanente Riverside Medical Center - Cardiology
Riverside, California, United States
Perlman Medical Offices at UC San Diego Health - Endocrinology
San Diego, California, United States
Retina Consultants of Southern Colorado, PC
Colorado Springs, Colorado, United States
New England Retina Associates
New London, Connecticut, United States
Rand Eye Institute
Deerfield Beach, Florida, United States
Retina Group of Florida - Fort Lauderdale
Fort Lauderdale, Florida, United States
Vitreo Retinal Associates PA - The Millennium Center Location
Gainesville, Florida, United States
Florida Retina Institute- Jacksonville Oak
Jacksonville, Florida, United States
Florida Eye Associates - Melbourne Main Office
Melbourne, Florida, United States
Retina Macula Specialists Of Miami - LeJeune Road Office
Miami, Florida, United States
Florida Retina Institute - Orlando
Orlando, Florida, United States
Retina Specialty Institute - Pensacola
Pensacola, Florida, United States
Retina Vitreous Associates of Florida - Saint Petersburg
St. Petersburg, Florida, United States
Southern Vitreoretinal Associates, P.L. - Tallahassee
Tallahassee, Florida, United States
Retina Consultants of Hawaii - Pali Momi Medical Center
‘Aiea, Hawaii, United States
Retina Associates IL
Elmhurst, Illinois, United States
University Retina and Macula Associates
Oak Forest, Illinois, United States
Wolfe Eye Clinic - Des Moines
West Des Moines, Iowa, United States
The Retina Care Center - Baltimore
Baltimore, Maryland, United States
Ophthalmic Consultants of Boston - Boston
Boston, Massachusetts, United States
Vitreo Retinal Surgery PA - Edina
Edina, Minnesota, United States
Retina Consultants of Nevada - Summerlin
Las Vegas, Nevada, United States
Retina Center of New Jersey
Bloomfield, New Jersey, United States
NJ Retina - Edison Office
Edison, New Jersey, United States
Eye Associates of New Mexico - Albuquerque - Retina Center
Albuquerque, New Mexico, United States
Long Island Vitreoretinal Consultants - Great Neck
Great Neck, New York, United States
Vitreoretinal Consultants of NY - Hauppauge
Hauppauge, New York, United States
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States
Ophthalmic Consultants of the Capital Region - Troy
Troy, New York, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Midwest Retina - Main Office
Dublin, Ohio, United States
Retina Northwest - NW Lovejoy
Portland, Oregon, United States
Retina Consultants, LLC
Salem, Oregon, United States
Mid Atlantic Retina - Philadelphia / Wills Eye Hospital
Bethlehem, Pennsylvania, United States
Erie Retinal Research
Erie, Pennsylvania, United States
Eye Care Specialists - Kingston, PA
Kingston, Pennsylvania, United States
Charleston Neuroscience Institute - Charleston
Charleston, South Carolina, United States
Palmetto Retina Center - West Columbia
West Columbia, South Carolina, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Charles Retina Specialists - Germantown
Memphis, Tennessee, United States
Vanderbilt University Medical School
Nashville, Tennessee, United States
Austin Retina Associates - Central
Austin, Texas, United States
Texas Retina Associates - Fort Worth
Fort Worth, Texas, United States
Medical Center Ophthalmology Associates - Northwest
San Antonio, Texas, United States
Retina Consultants of Texas - San Antonio Medical Center
San Antonio, Texas, United States
Retina Consultants of Texas (Retina Consultants of Houston) - Texas Medical Center
The Woodlands, Texas, United States
Retina Consultants of Texas - The Woodlands
The Woodlands, Texas, United States
The University of Vermont Medical Center (Fletcher Allen Health Care) - Main Campus
Burlington, Vermont, United States
Spokane Eye Clinical Research
Spokane, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
University of Wisconsin - Madison
Madison, Wisconsin, United States
Organizacion Medica de Investigacion (OMI)
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
OFTALMOS, Instituto Oftalmologico de Alta Complejidad
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Eyeclinic Albury Wodonga
Albury, New South Wales, Australia
Marsden Eye Surgery Center
Parramatta, New South Wales, Australia
Sydney Retina Clinic
Sydney, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Hobart Eye Surgeons
Hobart, Tasmania, Australia
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Carinthia, Austria
Medizinische Universität Graz
Graz, Styria, Austria
Kepler Universitätsklinikum Campus III
Linz, Upper Austria, Austria
Konventhospital Barmherzige Brüder Linz
Linz, Upper Austria, Austria
Hanusch-Krankenhaus Wien
Vienna, , Austria
SEHAT Pentagram
Sofia, , Bulgaria
Spec. Hosp. for Active Treatment for Eye Diseases Zrenie
Sofia, , Bulgaria
University Multiprofile Hospital For Active Treatment 'Alexandrovska' EAD
Sofia, , Bulgaria
Multiprofile Hospital for Active Treatment Sveta Sofia | Internal Diseases Department
Sofia, , Bulgaria
Specialized Hospital For Active Treatment of Eye Diseases Zora
Sofia, , Bulgaria
Sveta Petka Eye Hospital
Varna, , Bulgaria
St.Joseph's Health Care-London
London, Ontario, Canada
Toronto Retina Institute
Toronto, Ontario, Canada
Institut de l'Oeil des Laurentides
Boisbriand, Quebec, Canada
The Second Hospital of Anhui medical university
Hefei, Anhui, China
Beijing Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital, Capital Medical University (East)
Beijing, Dongcheng District, China
The 1st Affiliated Hospital Fujian Medical University
Fuzhou, Fujian, China
Guangzhou Aier Eye Hospital
Guangzhou, Guangdong, China
Hebei eye hospital
Hebei, Hebei, China
Shijiazhuang General Hospital
Shijiazhuang, Hebei, China
Henan Provincial Eye Hospital
Henan, Henan, China
Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
Wuhan, Hubei, China
Union Hospt Tongji Medical Colleg. Huazhong univ. Scien&Tech
Wuhan, Hubei, China
The First People's Hospital of Xuzhou
Xuzhou, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
The First Affiliated Hospital of NanChang University
Nanchang, Jiangxi, China
Eye Center of the second Bethune Hospital, jinlin University
Changchun, Jilin, China
Tonghua Central Hospital
Tonghua, Jilin, China
Shenyang He Eye Specialist Hospital
Shenyang, Liaoning, China
People's Hospital of Ningxia Hui Autonomous Region - Opthalmology
Ningxia, Ningxia, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Aier Eye Hospital (Chengdu)
Chengdu, Sichuan, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The 1st Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
ZheJiang Provincial People's Hospital
Hangzhou, Zhejiang, China
The Affiliated Eye Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, China
Beijing Aier Intech Eye Hospital
Beijing, , China
Peking University People's Hospital
Beijing, , China
Chongqing Aier Ophthalmology Hospital
Chongqing, , China
Shanghai Tongji Hospital of Tongji University
Shanghai, , China
Shanghai General Hospital
Shanghai, , China
Tianjin Medical University General Hospital
Tianjin, , China
Tianjin Eye Hospital
Tianjin, , China
Tianjin Medical University Eye Hospital
Tianjin, , China
Fakultní Nemocnice Hradec Kralové
Hradec Králové, , Czechia
Fakultní nemocnice Ostrava
Ostrava, , Czechia
Fakultni nemocnice Plzen - Lochotin
Plzen-Lochotin, , Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, , Czechia
Charles University in Prague
Prague, , Czechia
Lexum a.s., Evropska ocni klinika
Prague, , Czechia
Axon Clinical, s.r.o.
Prague, , Czechia
AS Ida-Tallinna Keskhaigla - Oftalmoloogiakeskus
Tallinn, , Estonia
Sihtasutus Tartu Ülikooli Kliinikum - Silmakliinik
Tartu, , Estonia
Centre d'Ophtalmologie - Paradis-Monticelli
Marseille, , France
AP-HP - Hopital Lariboisiere
Paris, , France
Centre ophtalmologique Saint-Exupéry
Saint-Cyr-sur-Loire, , France
LTD "Clinic LJ" - Opthalmology
Kutaisi, , Georgia
JSC "Evex Hospitals'
Tbilisi, , Georgia
LTD "Innova"
Tbilisi, , Georgia
LTD "Chichua Medical Center MZERA"
Tbilisi, , Georgia
Budapest Retina Associates
Budapest, , Hungary
Szent-Gyorgyi Albert Orvostudomanyi Egyetem
Szeged, , Hungary
Rambam Health Corporation
Haifa, , Israel
Lady Davis Carmel Medical Center
Haifa, , Israel
Hadassah Hebrew University Hospital Ein Kerem
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Kaplan Medical Center
Rehovot, , Israel
Assuta Medical Centers - HaShalom
Tel Aviv, , Israel
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Rome, Lazio, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia
Rome, Lazio, Italy
ASST Fatebenefratelli Sacco
Milan, Lombardy, Italy
Ospedale San Raffaele s.r.l. - Oculistica
Milan, Lombardy, Italy
Azienda Ospedaliero-Universitaria Di Cagliari
Cagliari, Sardinia, Italy
A.O. di Perugia
Perugia, Umbria, Italy
Daiyukai Daiichi Hospital
Ichinomiya, Aichi-ken, Japan
Aichi Medical University Hospital
Nagakute, Aichi-ken, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
Southern Tohoku Eye Clinic
Kōriyama, Fukushima, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
Sapporo City General Hospital
Sapporo, Hokkaido, Japan
KKR Sapporo Medical Center
Sapporo, Hokkaido, Japan
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki, Hyōgo, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Kozawa Eye Hospital and Diabetes Center
Mito, Ibaraki, Japan
Kanazawa Medical University Hospital
Kahoku-gun, Ishikawa-ken, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken, Japan
Medical corporation Eiwakai Dannoue Ophthalmology clinic
Kawasaki, Kanagawa, Japan
St. Marianna University Hospital
Kawasaki, Kanagawa, Japan
Otakeganka Tsukimino Clinic
Yamato, Kanagawa, Japan
Mie University Hospital
Tsu, Mie-ken, Japan
Shinshu University Hospital
Matsumoto, Nagano, Japan
Nara Medical University Hospital
Kashihara, Nara, Japan
Oita University Hospital
Yufu, Oita Prefecture, Japan
Kurashiki Medical Center
Kurashiki, Okayama-ken, Japan
Okayama University Hospital
Okayama, Okayama-ken, Japan
University of the Ryukyus Hospital
Nakagami, Okinawa, Japan
Kansai Medical University Hospital
Hirakata, Osaka, Japan
Kansai Medical University Medical Center
Moriguchi, Osaka, Japan
Kindai University Hospital
Osakasayama-shi, Osaka, Japan
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, Japan
St.Luke's International Hospital
Chuoku, Tokyo, Japan
Nishikasai Inouye Eye Hospital
Edogawa-ku, Tokyo, Japan
Tokyo Medical University Hachioji Medical Center
Hachiōji, Tokyo, Japan
Tokiwadai Muranaka Eye Clinic
Itabashi-ku, Tokyo, Japan
National Hospital Organization Tokyo Medical Center
Meguro-ku, Tokyo, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, Japan
University of Yamanashi Hospital
Chūō, Yamanashi, Japan
Akita University Hospital
Akita, , Japan
Hayashi Eye Hospital
Fukuoka, , Japan
Fukushima Medical University Hospital
Fukushima, , Japan
Hiroshima University Hospital
Hiroshima, , Japan
University of Miyazaki Hospital
Miyazaki, , Japan
Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki, , Japan
Japanese Red Cross Saitama Hospital
Saitama, , Japan
Tokushima University Hospital
Tokushima, , Japan
Japanese Red Cross Wakayama Medical center
Wakayama, , Japan
Yamagata University Hospital
Yamagata, , Japan
Department of Ophthalmology
Riga, , Latvia
Latvian American Eye Center
Riga, , Latvia
Riga East Clinical University Hospital "Gailezers"
Riga, , Latvia
Hospital of LT University of Health Sciences Kaunas Clinics
Kaunas, , Lithuania
PI Klaipedos University Hospital
Klaipėda, , Lithuania
Vilnius University Hospital Santaros Klinikos
Vilnius, , Lithuania
ALM Oftalmolaser - Oftalmologia Medica e Cirurgica
Lisbon, Lisbon District, Portugal
AIBILI
Coimbra, , Portugal
Espaco Medico de Coimbra
Coimbra, , Portugal
Centro Hospitalar Universitario do Porto
Porto, , Portugal
Centro Hospitalar Vila Nova de Gaia e Espinho | Unit 1 - Clinical Research Center
Porto, , Portugal
Scientific Research Institution of Ophthalmic Diseases
Moscow, , Russia
FBSI IRTC Eye Microsurgery n.a. acad. S.N. Fyodorov
Moscow, , Russia
Clinical Center of Serbia
Belgrade, , Serbia
Clinical hospital center Zvezdara
Belgrade, , Serbia
Klinicki centar Vojvodine
Novi Sad, , Serbia
National University Hospital Medical Centre
Singapore, , Singapore
Singapore National Eye Centre
Singapore, , Singapore
Fakultna nemocnica Nitra
Nitra, , Slovakia
Nemocnica s Poliklinikou Trebisov, Svet zdravia a.s.
Trebišov, , Slovakia
Fakultna nemocnica Trencin
Trenčín, , Slovakia
Fakultna nemocnica s poliklinikou Zilina
Žilina, , Slovakia
Nune Eye Hospital - Retina Center Ophthalmology
Seoul, Gangnam-gu, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, South Korea
Asan Medical Center - Oncology Department
Seoul, Seoul Teugbyeolsi, South Korea
Pusan National University Hospital
Busan, , South Korea
Inje University Haeundae Paik Hospital
Busan, , South Korea
Seoul National University Hospital (b)
Seoul, , South Korea
Samsung Medical Center - Oncology Department
Seoul, , South Korea
Instituto Oftalmologico Gomez-Ulla S.L. - Oftalmologia
Santiago de Compostela, A Coruña, Spain
Hospital Clínic i Provincial de Barcelona
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau | Gynecology Department
Barcelona, , Spain
Hospital Universitario Reina Sofia - Oftalmologia
Córdoba, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Hospital Universitario Y Politecnico La Fe - Oftalmologia
Valencia, , Spain
Hospital Universitario Miguel Servet - Oftalmologia
Zaragoza, , Spain
RétinElysée
Lausanne, Canton of Vaud, Switzerland
Berner Augenklinik am Lindenhofspital
Bern, , Switzerland
Stadtspital Triemli
Zurich, , Switzerland
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital at Linkou
Taoyuan District, , Taiwan
Private Enterprise Private Production Company "Acinus", Treatment and Diagnostic Center
Kropyvnytskyi, , Ukraine
Centralna Polyclinica MVS Ukraiiny
Kyiv, , Ukraine
Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi
Poltava, , Ukraine
Countries
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References
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Korobelnik JF, Lanzetta P, Leal S, Holz FG, Clark WL, Eichenbaum D, Iida T, Sun X, Berliner AJ, Schulze A, Zhao M, Schmelter T, Schmidt-Ott U, Zhang X, Morgan-Warren P, Hasanbasic Z, Vitti R, Chu KW, Reed K, Bhore R, Cheng Y, Bai Z, Hirshberg B, Yancopoulos GD, Wong TY; PULSAR Investigators. Intravitreal Aflibercept 8 mg in Neovascular Age-Related Macular Degeneration: Ninety-Six-Week Results from the Randomized Phase 3 PULSAR Trial. Ophthalmology. 2025 Aug 26:S0161-6420(25)00532-9. doi: 10.1016/j.ophtha.2025.08.022. Online ahead of print.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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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.
Other Identifiers
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2019-003851-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20968
Identifier Type: -
Identifier Source: org_study_id
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