A Study to Learn How Well a Higher Amount of Aflibercept Given as an Injection Into the Eye Works and How Safe it is in People With Reduced Vision Due to Swelling in the Macula, Central Part of the Retina Caused by a Blocked Vein in the Retina (Macula Edema Secondary to Retinal Vein Occlusion) (QUASAR)

Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of Aflibercept 8 mg in Macular Edema Secondary to Retinal Vein Occlusion

Researchers are looking for a better way to treat people who have macular edema secondary to retinal vein occlusion (RVO).

In people with RVO, a blood vessel that carries blood away from the retina (vein) becomes blocked. The retina is the very back part of the eye. The blocked vein causes fluid and blood to leak into the retina and thereby causes a swelling of the macula (the center of the retina responsible for fine vision). This swelling is called macular edema.

When a vein in the retina is blocked, the levels of a protein called vascular endothelial growth factor (VEGF) rises. VEGF helps the growth of new blood vessels. This can lead to macular edema and may cause the vision to become blurry.

The study treatment intravitreal (IVT) aflibercept is given as an injection into the eye. It works by blocking VEGF and this can help repair vision problems related to RVO. IVT aflibercept is already available and is prescribed by doctors as the standard of care treatment for macula edema secondary to RVO. Standard of care is a treatment that medical experts consider most appropriate for a disease.

Standard of care is given every 4 weeks in people with macula edema secondary to RVO. While repeated injections of aflibercept may prevent worsening of vision, it may place a burden on the patient. However, a higher amount (8 mg) compared to the standard of care (2 mg) of IVT aflibercept is being tested in studies. This higher amount could be given less often. The amount of IVT aflibercept given is measured in milligrams, also known as mg.

The main purpose of this study is to learn how well a higher amount of the study treatment aflibercept works in people with macular edema secondary to RVO. To answer this, researchers will measure changes in vision called best corrected visual acuity (BCVA) in the study participants between study start and after 36 weeks of treatment. Changes will then be compared between those participants who received the higher amount of IVT aflibercept and those that received standard of care.

To learn how safe the study treatment is in the participants, the researchers will count the number of participants from study start and up to 64 weeks later that have:

• adverse events
• serious adverse events

"Adverse events" are any medical problems that the participants have during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think they might be related to the study treatments. An adverse event is considered "serious" when it leads to death, puts the participants' lives at risk, requires hospitalization, causes disability, causes a baby being born with medical problems or is otherwise medically important.

Dependent on the treatment group, the participants will either receive the higher amount of aflibercept or standard of care as an intravitreal injection for up to 60 weeks. The study will consist of a test (screening) phase, a treatment phase and an end of study phase. Each participant will be in the study for up to 64 weeks.

One visit to the study site is planned during the screening phase, followed by visits approximately every 4 weeks (16 in total) during treatment and one visit at the end of the study.

During the study, the study doctors and their team will:

• check patients' eye health using various eye examination techniques
• measure patients' eye vision (BCVA)
• take blood and urine samples
• do physical examinations
• check vital signs
• examine heart health using electrocardiogram (ECG)
• do pregnancy tests in women of childbearing age

In addition, participants will be asked to fill a questionnaire on vision-related quality of life.

Study Overview

• Status: Completed
• Conditions: Macular Edema Secondary to Retinal Vein Occlusion
• Intervention / Treatment: Drug: Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose; Drug: Sham; Diagnostic test: Fluorescein; Drug: Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_2 mg

• Study Type: Interventional
• Enrollment (Actual): 892
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Albury, New South Wales, Australia, 2640
      • Eyeclinic Albury Wodonga
    • Parramatta, New South Wales, Australia, 2150
      • Marsden Eye Surgery Center
    • Strathfield, New South Wales, Australia, 2135
      • Strathfield Retina Clinic
    • Sydney, New South Wales, Australia, 2000
      • Sydney Eye Hospital
    • Sydney, New South Wales, Australia, 2000
      • Sydney Retina Clinic
    • Westmead, New South Wales, Australia, 2145
      • Sydney West Retina Pty Ltd
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Adelaide Eye and Retina Centre
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Hobart Eye Surgeons
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Centre for Eye Research
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Lion Eye Institute
• Austria
  • Vienna, Austria, 1090
    • Universitätsklinikum AKH Wien
  • 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, 4021
      • Konventhospital Barmherzige Brüder Linz
• Bulgaria
  • Sofia, Bulgaria, 1784
    • Specialized Hospital for Active Treatment of Eye Diseases Zora
  • Sofia, Bulgaria, 1309
    • SEHAT Pentagram
  • Varna, Bulgaria, 9000
    • Spec. Hosp. of Ophthalm. Disease for Active Treatment Varna
• China
  • Beijing, China, 100730
    • Peking Union Medical College Hospital CAMS
  • Beijing, China, 100029
    • China-Japan Friendship Hospital
  • Beijing, China, 100000
    • Beijing Aier Intech Eye Hospital
  • Beijing, China, 100062
    • Capital Medical University (CMU) - Beijing Tongren Hospital
  • Chongqing, China, 400020
    • Chongqing Aier Ophthalmology Hospital
  • Lanzhou, China, 730030
    • Lanzhou University - The Second Hospital (The Second Clinical Medical College of Lanzhou University)
  • Tianjin, China, 300384
    • Tianjin Medical University Eye Hospital
  • Anhui
    • Hefei, Anhui, China, 230601
      • The Second Hospital of Anhui Medical University
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Beijing Hospital
    • Beijing, Beijing Municipality, China, 100034
      • Peking University First Hospital - Oncology Department
  • 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.
  • Jilin
    • Changchun, Jilin, China, 130022
      • Eye Center of the second Bethune Hospital, jinlin University
  • Liaoning
    • Shenyang, Liaoning, China, 110082
      • The Fourth People's Hospital of Shenyang
    • Shenyang, Liaoning, China
      • Aier Eye Hospital (Liaoning)
  • Ningxia
    • Ningxia, Ningxia, China, 750002
      • People's Hospital of Ningxia Hui Autonomous Region - Opthalmology
  • Shaanxi
    • Shanxi, Shaanxi, China, 030002
      • Shanxi Eye Hospital
  • Shandong
    • Jinan, Shandong, China, 250000
      • Qilu Hosp., Shandong Univ.
  • Sichuan
    • Chengdu, Sichuan, China
      • Aier Eye Hospital (Chengdu)
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310014
      • Zhejiang Provincial People's Hospital
    • Jinhua, Zhejiang, China, 322199
      • Dongyang People's Hospital
• Czechia
  • Hradec Králové, Czechia, 500 05
    • Fakultni nemocnice Hradec Kralove
  • Ostrava, Czechia, 708 52
    • Fakultni Nemocnice Ostrava
  • Pardubice, Czechia, 530 03
    • Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice
  • Prague, Czechia, 12808
    • Vseobecna Fakultni Nemocnice V Praze
  • Prague, Czechia, 150 00
    • Axon Clinical, s.r.o.
  • Prague, Czechia, 10034
    • Fakultní nemocnice Královské Vinohrady - Urologická klinikay
  • Prague, Czechia, 140 00
    • Lexum a.s., Evropska ocni klinika
• Estonia
  • Tallinn, Estonia, 11412
    • Dr. Kai Noor Silmakabinet OÜ
  • Tallinn, Estonia, 10138
    • AS Ida-Tallinna Keskhaigla - Oftalmoloogiakeskus
  • Tartu, Estonia, 50406
    • Sihtasutus Tartu Ülikooli Kliinikum - Silmakliinik
• France
  • Bordeaux, France, 33076
    • CHU Bordeaux - Hopital Pellegrin - Ophtalmologie
  • Bordeaux, France, 33000
    • Clinique Rétine Tourny
  • Créteil, France, 94010
    • Hôpital Intercommunal - Créteil Cedex
  • Dijon, France, 21000
    • CHU Dijon - Hopital Francois Miterrand
  • Lyon, France, 69004
    • Hôpital de La Croix Rousse
  • Marseille, France, 13008
    • Centre d'Ophtalmologie - Paradis-Monticelli
  • Nantes, France, 44000
    • Clinique Jules Verne - Nantes
  • Paris, France, 75006
    • Centre d'ophtalmologie de l'Odéon
  • Paris, France, 75015
    • Centre Ophthalmologie d'Imagerie et de Laser
  • Paris, France, 75475
    • AP-HP - Hopital Lariboisiere
  • Strasbourg, France, 67000
    • CM Wolff
  • Tours, France, 37000
    • Centre Ophtalmologique Transparence - Tours
  • Cedex 12
    • Paris, Cedex 12, France, 75557
      • Centre Hospitalier National d'Ophthalmologie Quinze-Vingt
• Georgia
  • Tbilisi, Georgia, 114
    • LTD "Chichua Medical Center MZERA"
  • Tbilisi, Georgia, 0162
    • LTD "IQ Clinic"- Ophthalmology
• Germany
  • Bonn, Germany, 53127
    • Uniklinik Bonn / Eye Clinic
  • Heidelberg, Germany
    • Uni Heidelberg / Augenklinik
  • Ludwigshafen, Germany, 67063
    • Klinikum d. Stadt Ludwigshafen - Ophthalmology
  • Münster, Germany, 48145
    • St. Franziskus-Hospital Münster - Eye Center
  • Saarland
    • Sulzbach, Saarland, Germany, 66280
      • Knappschaftskrankenhaus Sulzbach
• Hungary
  • Budapest, Hungary, 1062
    • Magyar Honvédség Egészségügyi Központ
  • Budapest, Hungary, 1133
    • Budapest Retina Associates
  • Budapest, Hungary, 1083
    • University of Semmelweis/ Semmelweis Egyetem
  • Budapest, Hungary, 1106
    • Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Pécs, Hungary, 7621
    • Ganglion Medical Center
  • Szeged, Hungary, 6720
    • SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
• Israel
  • Beersheba, Israel, 8410101
    • Clalit Health | Soroka Medical Center - Internal Medicine Department
  • Haifa, Israel, 3109601
    • Rambam Health Corporation
  • Haifa, Israel, 3436212
    • Lady Davis Carmel Medical Center
  • Holon, Israel, 5822012
    • Edith Wolfson Medical Center | Internal Medicine Department
  • Jerusalem, Israel, 9112001
    • Hadassah Hebrew University Hospital Ein Kerem
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center | Beilinson Hospital - Internal Medicine C Department
  • Rehovot, Israel, 7610001
    • Kaplan Medical Center
  • Tel Aviv, Israel, 6423906
    • Tel-Aviv Sourasky Medical Center
  • Tel Aviv, Israel, 6789140
    • Assuta Medical Centers - HaShalom
  • Ẕerifin, Israel, 7030000
    • Shamir Medical Center (Assaf Harofeh)
• Italy
  • Ancona
    • Torrette, Ancona, Italy, 60126
      • Azienda Ospedaliero Universitaria Delle Marche - Clinica Oculistica
  • Lazio
    • Rome, Lazio, Italy, 00136
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oculistica
    • Rome, Lazio, Italy, 00133
      • Azienda Ospedaliera Policlinico Universitario Tor Vergata - Patologie Retiniche
    • Rome, Lazio, Italy, 00184
      • Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia - UOS Retina Medica
  • Lombardy
    • Milan, Lombardy, Italy, 20122
      • Asst Fatebenefratelli Sacco
    • Milan, Lombardy, Italy, 20122
      • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
    • Milan, Lombardy, Italy, 20132
      • Ospedale San Raffaele S.r.l.
• Japan
  • Akita, Japan, 010-8543
    • Akita University Hospital
  • Fukuoka, Japan, 812-0011
    • Hayashi Eye Hospital
  • Fukuoka, Japan, 819-8585
    • Murakami Karindoh Hospital
  • Fukushima, Japan, 960-1295
    • Fukushima Medical University Hospital
  • Kagoshima, Japan, 890-8520
    • Kagoshima University Hospital
  • Miyazaki, Japan, 889-1692
    • University of Miyazaki Hospital
  • Nagasaki, Japan, 852-8511
    • Japanese Red Cross Nagasaki Genbaku Hospital
  • Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Osaka, Japan, 545-8586
    • Osaka Metropolitan University Hospital
  • Saitama, Japan, 330-8553
    • Japanese Red Cross Saitama Hospital
  • Toyama, Japan, 930-0194
    • Toyama University Hospital
  • Wakayama, Japan, 640-8558
    • Japanese Red Cross Wakayama Medical Center
  • Yamagata, Japan, 990-9585
    • Yamagata University Hospital
  • Aichi-ken
    • Nagakute, Aichi-ken, Japan, 480-1195
      • Aichi Medical University Hospital
    • Nagoya, Aichi-ken, Japan, 467-8602
      • Nagoya City University Hospital
  • Chiba
    • Narita, Chiba, Japan, 286-8520
      • International University of Health and Welfare Narita Hospital
    • Sakura, Chiba, Japan, 285-8741
      • Toho University Sakura Medical Center
  • Fukui
    • Yoshida, Fukui, Japan, 910-1193
      • University of Fukui Hospital
  • Fukuoka
    • 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
  • Hyōgo
    • Amagasaki, Hyōgo, Japan, 660-8550
      • Hyogo Prefectural Amagasaki General Medical Center
    • Kobe, Hyōgo, Japan, 650-0017
      • Kobe University Hospital
    • Nishinomiya, Hyōgo, Japan, 663-8501
      • Hyogo Medical University Hospital
  • Ibaraki
    • Mito, Ibaraki, Japan, 310-0845
      • Kozawa Eye Hospital And Diabetes Center
    • Toride, Ibaraki, Japan, 302-0014
      • Matsumoto Eye Clinic
  • 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
    • Yokohama, Kanagawa, Japan, 232-0024
      • Yokohama City University Medical Center
  • Mie-ken
    • Tsu, Mie-ken, Japan, 514-8507
      • Mie University Hospital
  • Nagano
    • Matsumoto, Nagano, Japan, 390-8621
      • Shinshu University Hospital
  • Saitama
    • Tokorozawa, Saitama, Japan, 359-8513
      • National Defense Medical College hospital
  • Shiga
    • Ōtsu, Shiga, Japan, 520-2192
      • Shiga University of Medical Science Hospital
  • Shizuoka
    • Fujieda-shi, Shizuoka, Japan, 426-0029
      • Shida Eye Clinic
  • Tkyo
    • Chiyoda-ku, Tkyo, Japan, 101-8309
      • Nihon University Hospital
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8655
      • The University of Tokyo Hospital
    • Chōfu, Tokyo, Japan, 182-0024
      • Chofu Eye Clinic
    • Hachiōji, Tokyo, Japan, 193-0998
      • Tokyo Medical University Hachioji Medical Center
    • Itabashi-ku, Tokyo, Japan, 174-0071
      • Tokiwadai Muranaka Eye Clinic
    • Itabashi-ku, Tokyo, Japan, 173-0015
      • Tokyo Metropolitan Institute for Geriatrics and Gerontology
    • 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, 1002
    • Department of Ophthalmology
• Lithuania
  • Kaunas, Lithuania, LT-50161
    • Hospital of LT University of Health Sciences Kaunas Clinics
  • Vilnius, Lithuania, LT-08661
    • Vilnius University Hospital Santaros Klinikos
• Malaysia
  • Kuala Lumpur, Malaysia, 59200
    • OasisEye Specialists
  • Selangor
    • Bandar Puncak Alam, Selangor, Malaysia, 42300
      • Hospital Al-Sultan Abdullah, UiTM | Opthalmology
    • Shah Alam, Selangor, Malaysia, 68100
      • Hospital Selayang
    • Shah Alam, Selangor, Malaysia, 40000
      • Hospital Shah Alam | Ophthalmology
• Poland
  • Bydgoszcz, Poland, 85-631
    • Prywatna Klinika Okulistyczna OFTALMIKA
  • Bydgoszcz, Poland, 85-870
    • Specjalistyczny Osrodek Okulistyczny Oculomedica
  • Gdansk, Poland, 80-809
    • Profesorskie Centrum Okulistyki
  • Katowice, Poland, 40-594
    • Gabinet Okulistyczny Prof. Edward Wylegala
  • Krakow, Poland, 31-411
    • Centrum Medyczne Promed
  • Krakow, Poland, 31-070
    • Centrum Medyczne Dietla 19 Sp. z o.o.
  • Olsztyn, Poland, 10-424
    • Centrum Diagnostyki i Mikrochirurgii Oka LENS
  • Rzeszów, Poland, 35-017
    • Ośrodek Chirurgii Oka Prof. Zagórskiego Sp. Z o.o.
  • Wałbrzych, Poland, 58-304
    • Centrum Medyczne Piasta 47
• Portugal
  • Coimbra, Portugal, 3000-548
    • AIBILI
  • Coimbra, Portugal, 3000-548
    • Espaço Medico de Coimbra
  • Lisbon, Portugal, 1169-050
    • CHLC - Hospital dos Capuchos - Servico de Oftalmologia
  • 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
  • Porto, Portugal, 4200-319
    • Centro Hospitalar Universitario de Sao Joao | Polo Porto - Centro de Investigacao e Ensaios Clinicos
• Serbia
  • Belgrade, Serbia, 11000
    • Clinical Center of Serbia
  • Belgrade, Serbia, 11000
    • Clinical Hospital Center Zvezdara
  • Novi Sad, Serbia, 21000
    • Klinicki centar Vojvodine
• Slovakia
  • Banská Bystrica, Slovakia, 97517
    • Fakultna nemocnica s poliklinikou F.D.Roosevelta
  • Bratislava, Slovakia, 826 06
    • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
  • Bratislava, Slovakia, 851 07
    • Univerzitna nemocnica Bratislava, Nem. Sv. Cyrila a Metoda
  • Nitra, Slovakia, 950 01
    • Fakultna nemocnica Nitra
  • Trenčín, Slovakia, 911 71
    • Fakultna nemocnica Trencin
  • Zvolen, Slovakia, 96001
    • Specialized hospital for ophthalmology OPHTAL
• South Korea
  • Busan, South Korea, 49241
    • Pusan National University Hospital
  • Daegu, South Korea, 42415
    • Yeungnam University Medical Center
  • Gyeonggi-do, South Korea, 425-707
    • Korea University Ansan Hospital
  • Seoul, South Korea, 06351
    • Samsung Medical Center - Oncology Department
  • Seoul, South Korea, 150-034
    • Kim's Eye Hospital
  • Seoul, South Korea, 137-701
    • St. Mary Hospital
  • Gyeonggido
    • Seongnam-si, Gyeonggido, South Korea, 13620
      • Seoul National University Bundang Hospital
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 3080
      • Seoul National University Hospital
    • Seoul, Seoul Teugbyeolsi, South Korea, 03722
      • Severance Hospital, Yonsei University Health System
    • Seoul, Seoul Teugbyeolsi, South Korea, 05505
      • University of Ulsan College of Medicine - Asan Medical Center (AMC) - Ophthalmology
    • Seoul, Seoul Teugbyeolsi, South Korea, 6273
      • Gangnam Severance Hospital, Yonsei University Health System
• Spain
  • Barcelona, Spain, 08028
    • Hospital Clinic De Barcelona | Oftamologia
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall D Hebron | Oftalmologia
  • Barcelona, Spain, 8025
    • Hospital De La Santa Creu I Sant Pau | Oftalmologia
  • Pamplona, Spain, 31008
    • Clinica Universidad De Navarra | Oftalmologia
  • Valencia, Spain, 46014
    • Hospital General Universitario De Valencia | Oftalmologia
  • Valladolid, Spain, 47012
    • Hospital Universitario Rio Hortega | 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
  • Barcelona
    • Sant Cugat del Vallès, Barcelona, Spain, 08195
      • Hospital Universitari General De Catalunya | Oftalmologia
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta De Hierro De Majadahonda | Oftalmologia
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Universitatsspital Bern
  • Bern, Switzerland, TBC
    • Berner Augenklinik am Lindenhofspital
  • Binningen, Switzerland, 4102
    • Vista Klinik
  • Lausanne, Switzerland, 1004
    • University Eye Hospital Jules Gonin
  • Canton of Vaud
    • Lausanne, Canton of Vaud, Switzerland, 1006
      • RétinElysée
• Thailand
  • Chiang Mai, Thailand, 50200
    • Chiangmai University
  • Khon Kaen, Thailand, 40002
    • Srinagarind Hospital
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 6100
    • Hacettepe Universitesi Tip Fakultesi
  • Ankara, Turkey (Türkiye), 06170
    • Ankara Etlik City Hospital | Ophthalmology
  • Ankara, Turkey (Türkiye), 6010
    • Sbü Gülhane Eğitim Ve Araştirma Hastanesi
  • Ankara, Turkey (Türkiye), 6100
    • Ankara Numune Egitim ve Arastirma Hastanesi
  • Aydin, Turkey (Türkiye), 9100
    • Adnan Menderes Universitesi Tip fakultesi
  • Bilkent Ankara, Turkey (Türkiye), 6800
    • Ankara Bilkent Şehir Hastanesi
  • Kocaeli, Turkey (Türkiye), 41380
    • Kocaeli Universitesi Tip Fakultesi
• United Kingdom
  • East Riding Of Yorkshire
    • Hull, East Riding Of Yorkshire, United Kingdom, HU32JZ
      • Hull and East Yorkshire Eye Hospital Hull and East Yorkshire
  • Greater London
    • London, Greater London, United Kingdom, EC1V2PD
      • Moorfields Eye Hospital
  • Leicestershire
    • Leicester, Leicestershire, United Kingdom, LE1 5WW
      • Leicester Royal Infirmary
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L7 8XP
      • Royal Liverpool University Hospital
  • North Yorkshire
    • York, North Yorkshire, United Kingdom, YO611DW
      • York Teaching Hospital
  • Surrey
    • Frimley, Surrey, United Kingdom, GU167UJ
      • Frimley Park Hospital NHS
  • Tyne and Wear
    • Sunderland, Tyne and Wear, United Kingdom, SR29HP
      • Sunderland Eye Infirmary
  • West Midlands
    • Wolverhampton, West Midlands, United Kingdom, WV100QP
      • New Cross Hospital
  • West Yorkshire
    • Bradford, West Yorkshire, United Kingdom, BD9 6RJ
      • Bradford Royal Infirmary
    • Leeds, West Yorkshire, United Kingdom, LS9 7TF
      • Leeds Teaching Hospitals NHS Trust | St James's University Hospital - Oncology
• United States
  • California
    • Fullerton, California, United States, 92835
      • Retina Consultants of Orange County - Fullerton
    • Long Beach, California, United States, 90807
      • South Coast Retina - Long Beach
    • Mountain View, California, United States, 94040
      • Northern California Retina Vitreous Associates - Mountain View Office
    • Palm Springs, California, United States, 92262
      • Desert Retina Consultants - Palm Springs Office
    • Pasadena, California, United States, 91107
      • Azul Vision Pasadena
    • Redlands, California, United States, 92374
      • Retina Consultants of Southern California
  • 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 Myers, Florida, United States, 33912
      • National Ophthalmic Research Institute - Fort Myers
    • Largo, Florida, United States, 33770
      • The Eye Institute of West Florida - Largo
    • Melbourne, Florida, United States, 32901
      • Florida Eye Associates - Melbourne Main Office
    • Orlando, Florida, United States, 32806
      • Florida Retina Institute - Orlando
    • Pensacola, Florida, United States, 32503
      • Retina Specialty Institute - Pensacola
    • Plantation, Florida, United States, 33324
      • Fort Lauderdale Eye Institute
    • St. Petersburg, Florida, United States, 33711
      • Retina Vitreous Associates of Florida - Saint Petersburg
    • Stuart, Florida, United States, 34994
      • East Florida Eye Institute
    • Winter Haven, Florida, United States, 33880
      • Center for Retina and Macular Disease - Winter Haven
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Marietta Eye Clinic
  • Illinois
    • Elmhurst, Illinois, United States, 60126
      • Retina Associates - Elmhurst
    • Oak Forest, Illinois, United States, 60452
      • University Retina and Macula Associates - Oak Forest
  • Kansas
    • Lenexa, Kansas, United States, 66215
      • Retina Associates - Lenexa
  • Maryland
    • Baltimore, Maryland, United States, 21209
      • The Retina Care Center - Baltimore
    • Hagerstown, Maryland, United States, 21740
      • Mid Atlantic Retina Specialists - Hagerstown
    • Hagerstown, Maryland, United States, 21740
      • Cumberland Valley Retina Consultants | Hagerstown, MD
  • Michigan
    • Grand Rapids, Michigan, United States, 49525
      • Vitreo-Retinal Associates - Worcester
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55416
      • RCM - St. Louis Park Retina Clinic
  • 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
    • New Brunswick, New Jersey, United States, 08901
      • NJ Retina - New Brunswick
    • Teaneck, New Jersey, United States, 07666
      • NJ Retina | Teaneck
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Vision Research Center
  • New York
    • Great Neck, New York, United States, 11021
      • Vitreoretinal Consultants of NY - Great Neck
    • Hauppauge, New York, United States, 11788
      • Vitreoretinal Consultants of NY - Hauppauge
    • Lynbrook, New York, United States, 11563
      • Ophthalmic Consultants of Long Island
    • Rochester, New York, United States, 14620
      • Retina Associates of Western New York
  • Ohio
    • Blue Ash, Ohio, United States, 45242-5664
      • Cincinnati Eye Institute - Blue Ash
    • Dublin, Ohio, United States, 43016
      • Midwest Retina - Main Office
  • Oregon
    • Salem, Oregon, United States, 97302
      • Retina Consultants, LLC
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18107
      • Mid Atlantic Retina - Bethlehem
    • Philadelphia, Pennsylvania, United States, 19107
      • Mid Atlantic Retina - Philadelphia / Wills Eye Hospital
  • South Carolina
    • Florence, South Carolina, United States, 29501
      • Palmetto Retina Center, LLC - Florence
    • Ladson, South Carolina, United States, 29456
      • Retina Consultants of South Carolina - Ladson
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Charles Retina Specialists - Germantown
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Retina Associates - Central
    • Bellaire, Texas, United States, 77401
      • Retina Consultants of Texas - Bellaire
    • 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
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Rocky Mountain Retina Consultants - Main Office
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • The Retina Group of Washington - Fairfax
  • Washington
    • Spokane, Washington, United States, 99204
      • Spokane Eye Clinical Research - South Hill / Downtown
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • UW Health Carbone Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult ≥18 years of age (or country's legal age of adulthood if the legal age is >18 years) at the time of signing the informed consent.
• Treatment-naïve macular edema involving the foveal center secondary to RVO (BRVO, HRVO, or CRVO) diagnosed within 16 weeks (112 days) before the screening visit in the study eye.
• Early Treatment Diabetic Retinopathy Study BCVA letter score of 73 to 24 (20/40 to 20/320) at screening and baseline visits in the study eye.

Decrease in BCVA determined to be primarily the result of RVO in the study eye.

• Mean CST ≥300 μm on optical coherence tomography (OCT) if excluding Bruch's membrane (e.g., Cirrus or Topcon) or ≥320 μm if including Bruch's membrane (e.g., Heidelberg Spectralis), confirmed by the reading center at the screening visit and by the site at baseline visit in the study eye.
• Capable of giving signed informed consent form (ICF) by study participant or legally acceptable representative, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
• US participants will be required to have a Health Insurance Portability and Accountability Act (HIPAA) authorization; in other countries, as applicable according to national laws.
• Women of childbearing potential (WOCBP) or men who are sexually active with partners of childbearing potential must agree to use highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 4 months after the last administration of study intervention. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for participation in clinical studies and fulfil the conditions set on Section 10.4.2.

Exclusion Criteria:

• Concurrent disease that causes substantial decrease of BCVA, is expected to limit BCVA recovery or is likely to require medical or surgical intervention during the study in the study eye.

• Presence or history of the following ocular conditions:

  1. Advanced age-related macular degeneration (neovascular AMD or geographic atrophy) in the study eye.
  2. Diabetic macular edema or diabetic retinopathy, defined in diabetic participants as diabetic retinopathy lesions outside the area of the vein occlusion in the study eye and anywhere in the retina in the fellow eye.
  3. Anterior segment neovascularization, vitreous hemorrhage, retinal detachment in the study eye.
  4. Vitreomacular traction, epiretinal membrane or structural damage to the macula that is considered by the Investigator to significantly affect central vision or preclude improvement in vision in the study eye.
  5. Macular hole of stage 2 and above in the study eye.
  6. Myopia of a spherical equivalent of at least 8 diopters prior to any refractive or cataract surgery in the study eye.
  7. Corneal transplant or corneal dystrophy in the study eye.
  8. Idiopathic or autoimmune uveitis in the study or in the fellow eye.

• Presence of the following ocular conditions at screening or baseline visit:

  1. Significant media opacities, including cataract, that interfere with BCVA, or imaging assessments (e.g., fundus photography [FP], OCT) in the study eye.
  2. Aphakia, or pseudophakia with absence of posterior capsule (unless it occurred as a result of a yttrium-aluminum-garnet [YAG] posterior capsulotomy performed more than 30 days before the screening visit), in the study eye.
  3. Uncontrolled glaucoma (defined as IOP >25 mmHg despite treatment with anti-glaucoma medication); or history or likely future need of glaucoma surgery in the study eye.
  4. Intraocular inflammation/infection (including trace, or above, cells in the anterior chamber and/or vitreous) within 12 weeks (84 days) of the screening visit in the study or in the fellow eye.
  5. Extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in the study or in the fellow eye.
• Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg) at the screening visit or baseline visit.
• Uncontrolled diabetes mellitus, defined by hemoglobin A1c (HbA1c) >12% at the screening visit.
• History of cerebrovascular accident or myocardial infarction within 24 weeks (168 days) before the screening visit or between screening and baseline visits.
• Renal failure requiring dialysis, or renal transplant at screening or potentially during the study.
• Any prior or concomitant ocular or systemic treatment (with an investigational or approved, anti-VEGF or other agent) or surgery for RVO in the study eye.
• Previous administration of systemic anti-angiogenic medications for any condition.

• Prior treatment of the study eye with any of the following drugs (any route of ophthalmic administration) or procedures:

  1. Anti-angiogenic drugs at any time including investigational therapy (e.g., with anti-angiopoietin/anti-VEGF bispecific monoclonal antibodies).
  2. Previous use topical steroids within 4 weeks (28 days) from the screening visit, or intraocular or periocular steroids within 16 weeks (112 days) from the screening visit, or steroid implants at any time.
  3. Previous treatment with intraocular or periocular implant, gene therapy, or cell therapy at any time.
  4. Treatment with ocriplasmin at any time.
  5. Vitreoretinal surgery (including scleral buckling) at any time.
  6. Any intraocular surgery, including cataract surgery, within 12 weeks (84 days) before the screening visit.
  7. Previous treatment with retinal laser photocoagulation.

• Prior treatment of the fellow eye with any of the following:

  a. Gene therapy, or cell therapy in the fellow eye at any time.

• Participation in other clinical studies requiring administration of investigational treatments (other than vitamins and minerals) at the time of screening visit, or within 30 days or 5 half-lives of administration of the previous study intervention, whichever is longer.

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
Experimental: Higher Dose Regimen 1; Higher dose of aflibercept is administered with initial initiation doses intervals, followed by extension of treatment intervals and further adjustment of intervals according to treatment response.	Drug: Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose; Intravitreally (IVT) injection.; Drug: Sham; Sham procedure will be given on visits when an active injection is not planned.; Diagnostic test: Fluorescein; Fluorescein 100 mg/mL solution for injection is a dye that makes the retinal vessels visible during FA examinations, and as such, it will be used as an auxiliary medicinal product (AxMP) in this periodic ophthalmic examination. This medicine is for diagnostic use only. It is not used to treat any condition.
Experimental: Higher Dose Regimen 2; Higher dose of aflibercept is administered with initial initiation doses intervals, followed by extension of treatment intervals and further adjustment of intervals according to treatment response.	Drug: Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose; Intravitreally (IVT) injection.; Drug: Sham; Sham procedure will be given on visits when an active injection is not planned.; Diagnostic test: Fluorescein; Fluorescein 100 mg/mL solution for injection is a dye that makes the retinal vessels visible during FA examinations, and as such, it will be used as an auxiliary medicinal product (AxMP) in this periodic ophthalmic examination. This medicine is for diagnostic use only. It is not used to treat any condition.
Active Comparator: Standard of care; Aflibercept 2 mg is administered by standard treatment intervals, followed by adjustment of treatment intervals according to treatment response.	Diagnostic test: Fluorescein; Fluorescein 100 mg/mL solution for injection is a dye that makes the retinal vessels visible during FA examinations, and as such, it will be used as an auxiliary medicinal product (AxMP) in this periodic ophthalmic examination. This medicine is for diagnostic use only. It is not used to treat any condition.; Drug: Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_2 mg; Intravitreally (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 36	BCVA: Best-Corrected Visual Acuity; ETDRS: Early Treatment Diabetic Retinopathy Study; ETDRS letter score (ranging from 0 to 100 letters). A higher letter score means a better outcome (better visual acuity)	At Week 36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Active Injections From Baseline to Week 36	Active injections refer to the number of injections that were actually administered, as opposed to the number of planned injections.	From baseline to Week 36
Participants Gaining at Least 15 Letters in BCVA From Baseline at Week 36		From baseline at Week 36
Participants Achieving an ETDRS Letter Score of at Least 69 (Approximate 20/40 Snellen Equivalent) at Week 36	ETDRS letter score (ranging from 0 to 100 letters). A higher letter score means a better outcome (better visual acuity)	At Week 36
Participants Having no Intraretinal Fluid (IRF) and no Sub-retinal Fluid (SRF) in the Center Subfield at Week 36	Number of participants with no retinal fluid (no IRF and no SRF) in the central subfield at Week 36	At Week 36
Change From Baseline in Central Sub-field Thickness (CST) at Week 36		From baseline to Week 36
Change From Baseline in NEI VFQ 25 Total Score at Week 36	NEI-VFQ-25: National Eye Institute Visual Functioning Questionnaire-25; The NEI VFQ-25 total score ranges from 0 to 100. A higher score means a better outcome (better patient-reported visual function).	From baseline to Week 36
Participants Dosed Only Q8 Through Week 36 in the 8 mg Q8 Group	Number of participants in the aflibercept 8q8/3 and the aflibercept 8q8/5 groups who were able to maintain every 8 weeks (Q8) dosing through Week 36. Only participants who did not discontinue study intervention prior to Week 36, and were therefore considered "completers" for Week 36, were included in the analysis of this endpoint.	Through Week 36
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Through Weeks 36	TEAEs were defined as AEs that occurred in the time frame from first injection (active or sham) to the last injection (active or sham) plus 30 days. Ocular TEAEs in study eye and non-ocular TEAEs are included (ocular TEAEs in fellow eye are excluded)	Through Week 36
Systemic Exposure to Aflibercept as Assessed by Plasma Concentrations of Free, Adjusted Bound and Total Aflibercept From Baseline Through Weeks 36	Total aflibercept is the sum of free and adjusted bound aflibercept.	From baseline through Week 36

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Regeneron Pharmaceuticals

Publications and helpful links

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): May 15, 2023
• Primary Completion (Actual): November 7, 2024
• Study Completion (Actual): May 27, 2025

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms; Eye Diseases; Neoplastic Processes; Embolism and Thrombosis; Retinal Diseases; Retinal Degeneration; Macular Degeneration; Venous Thrombosis; Thrombosis; Neoplasm Metastasis; Edema; Macular Edema; Retinal Vein Occlusion; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques, Ophthalmological; Angiography; salicylhydroxamic acid; aflibercept; Fluorescein Angiography
• Other Study ID Numbers: 22153; 2022-502174-16-00 (Other Identifier: CTIS (EU))

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