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: Recruiting
• 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 (Estimated): 822
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: (+)1-888-84 22937; Email: clinical-trials-contact@bayer.com

Study Locations

• Australia
  • New South Wales
    • Albury, New South Wales, Australia, 2640
      • Active, not recruiting
      • Eyeclinic Albury Wodonga
    • Parramatta, New South Wales, Australia, 2150
      • Active, not recruiting
      • Marsden Eye Surgery Center
    • Strathfield, New South Wales, Australia, 2135
      • Active, not recruiting
      • Strathfield Retina Clinic
    • Sydney, New South Wales, Australia, 2000
      • Active, not recruiting
      • Sydney Eye Hospital
    • Sydney, New South Wales, Australia, 2000
      • Active, not recruiting
      • Sydney Retina Clinic
    • Westmead, New South Wales, Australia, 2145
      • Active, not recruiting
      • Sydney West Retina Pty Ltd
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Completed
      • Adelaide Eye and Retina Centre
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Active, not recruiting
      • Hobart Eye Surgeons
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Active, not recruiting
      • Centre for Eye Research
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Completed
      • Lions Eye Institute
• Austria
  • Linz, Austria, 4021
    • Withdrawn
    • Kepler Universitätsklinikum Campus III
  • Wien, Austria, 1090
    • Active, not recruiting
    • Universitätsklinikum AKH Wien
  • Wien, Austria, 1140
    • Active, not recruiting
    • Hanusch-Krankenhaus Wien
  • Kärnten
    • Klagenfurt, Kärnten, Austria, 9020
      • Active, not recruiting
      • Klinikum Klagenfurt am Wörthersee
  • Oberösterreich
    • Linz, Oberösterreich, Austria, 4021
      • Active, not recruiting
      • Konventhospital Barmherzige Brüder Linz
  • Steiermark
    • Graz, Steiermark, Austria, 8036
      • Active, not recruiting
      • Medizinische Universität Graz
• Bulgaria
  • Sofia, Bulgaria, 1309
    • Active, not recruiting
    • SEHAT Pentagram
  • Sofia, Bulgaria, 1431
    • Withdrawn
    • UMHAT Alexandrovska EAD
  • Sofia, Bulgaria, 1618
    • Withdrawn
    • Multiprofile Hospital for Active Treatment Sveta Sofia
  • Sofia, Bulgaria, 1784
    • Active, not recruiting
    • Specialized Hospital For Active Treatment of Eye Diseases Zora
  • Varna, Bulgaria, 9000
    • Active, not recruiting
    • Spec. Hosp. of Ophthalm. Disease for Active Treatment Varna
• China
  • Beijing, China, 100730
    • Active, not recruiting
    • Beijing Hospital
  • Beijing, China
    • Active, not recruiting
    • Peking University First Hospital
  • Beijing, China, 100730
    • Completed
    • Peking Union Medical College Hospital CAMS
  • Beijing, China, 100029
    • Active, not recruiting
    • China-Japan Friendship Hospital
  • Beijing, China, 100021
    • Active, not recruiting
    • Beijing Aier Intech Eye Hospital Co. LTD - Ophthalmology
  • Beijing, China, 100730
    • Withdrawn
    • Beijing Tongren Hospital, Capital Medical University (West)
  • Beijing, China, 100730
    • Active, not recruiting
    • Capital Medical University (CMU) - Beijing Tongren Hospital
  • Chongqing, China, 400020
    • Completed
    • Chongqing Aier Ophthalmology Hospital
  • Chongqing, China, 401147
    • Withdrawn
    • The First Affiliated Hospital of Chongqing Medical Universit
  • Chongqing, China
    • Withdrawn
    • Second Hospital Affiliated of Chongqing Medical University
  • Hangzhou, China, 310003
    • Withdrawn
    • Zhejiang University School of Medicine - The First Affiliated Hospital - Kidney Disease Center
  • Lanzhou, China, 730030
    • Active, not recruiting
    • Lanzhou University - The Second Hospital (The Second Clinical Medical College of Lanzhou University)
  • Shanghai, China
    • Withdrawn
    • Eye & ENT Hospital of Fudan University
  • Shenyang, China, 110001
    • Withdrawn
    • China Medical University (CMU) - First Affiliated Hospital
  • Tianjin, China, 300052
    • Withdrawn
    • Tianjin Medical University General Hospital
  • Tianjin, China, 300384
    • Active, not recruiting
    • Tianjin Medical University Eye Hospital
  • Tianjin, China
    • Withdrawn
    • TianJin eye hospital
  • Anhui
    • Hefei, Anhui, China, 230601
      • Active, not recruiting
      • The Second Hospital of Anhui Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 634050
      • Active, not recruiting
      • Guangzhou Aier Eye Hospital
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Active, not recruiting
      • Shijiazhuang General Hospital
    • Xingtai, Hebei, China
      • Active, not recruiting
      • Hebei Eye Hospital
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Active, not recruiting
      • Henan Provincial Ophthalmology Hospital (Henan Eye Institute
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Active, not recruiting
      • Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
    • Wuhan, Hubei, China, 430040
      • Withdrawn
      • Renmin Hospital of Wuhan University
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221002
      • Withdrawn
      • The First People's Hospital of Xuzhou
  • Jilin
    • Changchun, Jilin, China, 130022
      • Active, not recruiting
      • Eye Center of the second Bethune Hospital, jinlin University
  • Liaoning
    • Shenyang, Liaoning, China, 110031
      • Active, not recruiting
      • Shenyang Fourth People's Hospital - Ophthalmology
    • Shenyang, Liaoning, China
      • Active, not recruiting
      • Aier Eye Hospital(SHENYANG)
  • Ningxia
    • Yinchuan, Ningxia, China, 750000
      • Active, not recruiting
      • The People's Hospital of Ningxia Hui Autonomous Region
  • Shaanxi
    • Taiyuan, Shaanxi, China, 030072
      • Active, not recruiting
      • Shanxi Provincial Eye Hospital
    • Xi'an, Shaanxi, China, 710061
      • Withdrawn
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Shandong
    • Jinan, Shandong, China, 250012
      • Active, not recruiting
      • Qilu Hospital of Shandong University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Withdrawn
      • West China Hospital,Sichuan University
    • Chengdu, Sichuan, China
      • Active, not recruiting
      • Aier Eye Hospital (Chengdu)
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310014
      • Active, not recruiting
      • Zhejiang Provincial People's Hospital
    • Jinhua, Zhejiang, China, 322199
      • Active, not recruiting
      • Dongyang People's Hospital
    • Wenzhou, Zhejiang, China
      • Withdrawn
      • The Affiliated Eye Hospital of Wenzhou Medical College
• Czechia
  • Hradec Kralove, Czechia, 500 05
    • Withdrawn
    • Fakultni nemocnice Hradec Kralove
  • Ostrava, Czechia, 708 52
    • Active, not recruiting
    • Fakultni Nemocnice Ostrava
  • Pardubice, Czechia, 53003
    • Active, not recruiting
    • Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice
  • Praha 10, Czechia, 10034
    • Active, not recruiting
    • FN Kralovske Vinohrady
  • Praha 2, Czechia, 12800
    • Active, not recruiting
    • Všeobecná fakultní nemocnice v Praze
  • Praha 4, Czechia, 140 00
    • Active, not recruiting
    • Lexum a.s., Evropska ocni klinika
  • Praha 5, Czechia, 150 00
    • Active, not recruiting
    • AXON Clinical s.r.o.
• Estonia
  • Tallinn, Estonia, 10138
    • Active, not recruiting
    • East Tallinn Central Hospital
  • Tallinn, Estonia, 11314
    • Withdrawn
    • Turman Eye Clinic
  • Tallinn, Estonia, 11412
    • Withdrawn
    • Dr. Kai Noor Silmakabinet OU
  • Tartu, Estonia
    • Active, not recruiting
    • Tartu University Hospital
• France
  • Bordeaux, France, 33000
    • Active, not recruiting
    • Clinique Rétine Tourny
  • Bordeaux, France, 33076
    • Active, not recruiting
    • CHU Bordeaux - Hopital Pellegrin - Ophtalmologie
  • Creteil Cedex, France, 94010
    • Withdrawn
    • Hôpital Intercommunal - Créteil Cedex
  • Dijon, France, 21000
    • Active, not recruiting
    • Hôpital François Mitterrand - Dijon
  • Lyon Cedex 04, France, 69317
    • Completed
    • Hôpital de la Croix Rousse
  • Marseille, France, 13008
    • Active, not recruiting
    • Centre d'Ophtalmologie - Paradis-Monticelli
  • Nantes, France, 44000
    • Active, not recruiting
    • Clinique Jules Verne - Nantes
  • Paris, France, 75006
    • Completed
    • Centre d'ophtalmologie de l'Odéon
  • Paris, France, 75010
    • Active, not recruiting
    • Hôpital Lariboisière - Paris
  • Paris, France, 75015
    • Active, not recruiting
    • Centre Ophthalmologie d'Imagerie et de Laser
  • Strasbourg, France, 67000
    • Active, not recruiting
    • CM Wolff
  • Tours, France, 37000
    • Active, not recruiting
    • Centre Ophtalmologique Transparence - Tours
  • Cedex 12
    • Paris, Cedex 12, France, 75557
      • Withdrawn
      • Centre Hospitalier National d'Ophthalmologie Quinze-Vingt
• Georgia
  • Tbilisi, Georgia, 0162
    • Active, not recruiting
    • LTD "IQ Clinic"- Ophthalmology
  • Tbilisi, Georgia, 112
    • Withdrawn
    • LTD Israeli-Georgian Medical Research Clinic "Helsicore"
  • Tbilisi, Georgia, 114
    • Active, not recruiting
    • LTD "Chichua Medical Center MZERA"
  • Tbilisi, Georgia
    • Withdrawn
    • Caucasus Medical Center- Opthamology
• Germany
  • Bonn, Germany, 53127
    • Not yet recruiting
    • Uniklinik Bonn / Eye Clinic
  • Düsseldorf, Germany, 40225
    • Withdrawn
    • Universitätsklinikum Düsseldorf / Ophthalmology
  • Göttingen, Germany, 37075
    • Withdrawn
    • Universitätsmedizin Göttingen - Ophthalmology
  • Hannover, Germany, 30625
    • Recruiting
    • Medizinische Hochschule Hannover (MHH) - University Clinic for Ophthalmology
  • Heidelberg, Germany
    • Not yet recruiting
    • Uni Heidelberg / Augenklinik
  • Jena, Germany, 07747
    • Withdrawn
    • Universitaetsklinikum Jena - Ophthalmology
  • Ludwigshafen, Germany, 67063
    • Not yet recruiting
    • Klinikum d. Stadt Ludwigshafen - Ophthalmology
  • Marburg, Germany, 35043
    • Withdrawn
    • Universitätsklinik Gießen und Marburg GmbH (UKGM) - Ophthalmology
  • Muenster, Germany, 48145
    • Not yet recruiting
    • St. Franziskus-Hospital Münster - Eye Center
  • Munich, Germany, 80336
    • Withdrawn
    • Ludwig-Maximilians-Universitaet Muenchen (LMU) Klinikum - Eye Clinic and Polyclinic
  • Tuebingen, Germany, 72076
    • Withdrawn
    • Universitaetsklinikum Tuebingen - Ophthalmology
  • Baden-Württemberg
    • Freiburg, Baden-Württemberg, Germany, 79106
      • Withdrawn
      • Universitätsklinikum Freiburg
  • Saarland
    • Sulzbach, Saarland, Germany, 66280
      • Not yet recruiting
      • Knappschaftskrankenhaus Sulzbach
• Hungary
  • Budapest, Hungary, 1062
    • Active, not recruiting
    • Magyar Honvedseg Egeszsegugyi Kozpont
  • Budapest, Hungary, 1024
    • Withdrawn
    • Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet
  • Budapest, Hungary, 1085
    • Active, not recruiting
    • University of Semmelweis/ Semmelweis Egyetem
  • Budapest, Hungary, 1106
    • Active, not recruiting
    • Bajcsy Zsilinszky Korhaz-Rendelointezet
  • Budapest, Hungary, 1133
    • Active, not recruiting
    • Budapest Retina Associates
  • Debrecen, Hungary, 4032
    • Active, not recruiting
    • Debreceni Egyetem Klinikai Kozpont
  • Pecs, Hungary, 7621
    • Active, not recruiting
    • Ganglion Medical Center
  • Szeged, Hungary, 6720
    • Active, not recruiting
    • SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
• Israel
  • Beer Sheva, Israel, 8410101
    • Active, not recruiting
    • Soroka University Medical Center
  • Haifa, Israel, 3109601
    • Active, not recruiting
    • Rambam Health Corporation
  • Haifa, Israel, 3436212
    • Active, not recruiting
    • Lady Davis Carmel Medical Center
  • Holon, Israel, 5822012
    • Active, not recruiting
    • Edith Wolfson Medical Center
  • Jerusalem, Israel, 91120
    • Active, not recruiting
    • Hadassah Hebrew University Hospital Ein Kerem
  • Kfar Saba, Israel, 4428164
    • Completed
    • Meir Medical Center
  • Petah Tikva, Israel, 4941492
    • Active, not recruiting
    • Clalit Health Services Rabin Medical Center-Beilinson Campus
  • Rehovot, Israel, 7661041
    • Active, not recruiting
    • Kaplan Medical Center
  • Tel Aviv, Israel, 6423906
    • Active, not recruiting
    • Tel-Aviv Sourasky Medical Center
  • Tel Aviv, Israel, 6789140
    • Active, not recruiting
    • Assuta Medical Centers - HaShalom
  • Zerifin, Israel, 7030000
    • Active, not recruiting
    • Shamir Medical Center (Assaf Harofeh)
• Italy
  • Milano, Italy, 20122
    • Withdrawn
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Lazio
    • Roma, Lazio, Italy, 00133
      • Active, not recruiting
      • Fondazione PTV Policlinico Tor Vergata
    • Roma, Lazio, Italy, 00168
      • Active, not recruiting
      • Fondazione Policlinico Universitario Agostino Gemelli Irccs
    • Roma, Lazio, Italy, 00198
      • Active, not recruiting
      • IRCCS Fondazione G.B. Bietti Studio e Ricerca in Otalmologia
  • Lombardia
    • Milano, Lombardia, Italy, 20132
      • Withdrawn
      • Ospedale San Raffaele s.r.l.
    • Milano, Lombardia, Italy, 20157
      • Withdrawn
      • ASST Fatebenefratelli Sacco
  • Marche
    • Ancona, Marche, Italy, 60126
      • Active, not recruiting
      • A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"
  • Piemonte
    • Torino, Piemonte, Italy, 10128
      • Withdrawn
      • A.O. Ordine Mauriziano
  • Puglia
    • Bari, Puglia, Italy, 70124
      • Withdrawn
      • A.O.U. Consorziale Policlinico
• Japan
  • Akita, Japan, 010-8543
    • Recruiting
    • Akita University Hospital
  • Fukuoka, Japan, 812-0011
    • Recruiting
    • Hayashi Eye Hospital
  • Fukuoka, Japan, 819-8585
    • Recruiting
    • Murakami Karindoh Hospital
  • Fukushima, Japan, 960-1295
    • Recruiting
    • Fukushima Medical University Hospital
  • Kagoshima, Japan, 890-8520
    • Recruiting
    • Kagoshima University Hospital
  • Miyazaki, Japan, 889-1692
    • Recruiting
    • University of Miyazaki Hospital
  • Nagasaki, Japan, 852-8511
    • Recruiting
    • Japanese Red Cross Nagasaki Genbaku Hospital
  • Osaka, Japan, 545-8586
    • Recruiting
    • Osaka Metropolitan University Hospital
  • Saitama, Japan, 330-8553
    • Recruiting
    • Japanese Red Cross Saitama Hospital
  • Wakayama, Japan, 640-8558
    • Recruiting
    • Japanese Red Cross Wakayama Medical center
  • Yamagata, Japan, 990-9585
    • Recruiting
    • Yamagata University Hospital
  • Aichi
    • Nagoya, Aichi, Japan, 467-8602
      • Recruiting
      • Nagoya City University Hospital
  • Chiba
    • Narita, Chiba, Japan, 286-8520
      • Recruiting
      • International University of Health & Welfare Narita Hospital
    • Sakura, Chiba, Japan, 285-8741
      • Recruiting
      • Toho University Sakura Medical Center
  • Fukui
    • Yoshida, Fukui, Japan, 910-1193
      • Recruiting
      • University of Fukui Hospital
  • Fukuoka
    • Kurume, Fukuoka, Japan, 830-0011
      • Recruiting
      • Kurume University Hospital
  • Fukushima
    • Koriyama, Fukushima, Japan, 963-8052
      • Recruiting
      • Southern Tohoku Eye Clinic
  • Gunma
    • Maebashi, Gunma, Japan, 371-8511
      • Recruiting
      • Gunma University Hospital
  • Hyogo
    • Amagasaki, Hyogo, Japan, 660-8550
      • Recruiting
      • Hyogo Prefectural Amagasaki General Medical Center
    • Kobe, Hyogo, Japan, 650-0017
      • Recruiting
      • Kobe University Hospital
    • Nishinomiya, Hyogo, Japan, 663-8501
      • Recruiting
      • Hyogo Medical University Hospital
  • Ibaraki
    • Mito, Ibaraki, Japan, 310-0845
      • Recruiting
      • Kozawa Eye Hospital and Diabetes Center
    • Toride, Ibaraki, Japan, 302-0014
      • Recruiting
      • Matsumoto Eye Clinic
  • Kagawa
    • Kita-gun, Kagawa, Japan, 761-0793
      • Recruiting
      • Kagawa University Hospital
  • Kanagawa
    • Kawasaki, Kanagawa, Japan, 211-0053
      • Recruiting
      • Medical corporation Eiwakai Dannoue Ophthalmology clinic
    • Yokohama, Kanagawa, Japan, 232-0024
      • Recruiting
      • Yokohama City University Medical Center
  • Mie
    • Tsu, Mie, Japan, 514-8507
      • Not yet recruiting
      • Mie University Hospital
  • Nagano
    • Matsumoto, Nagano, Japan, 390-8621
      • Recruiting
      • Shinshu University Hospital
  • Saitama
    • Tokorozawa, Saitama, Japan, 359-8513
      • Recruiting
      • National Defense Medical College Hospital
  • Shiga
    • Otsu, Shiga, Japan, 520-2192
      • Recruiting
      • Shiga University Of Medical Science Hospital
  • Shizuoka
    • Fujieda, Shizuoka, Japan, 426-0029
      • Withdrawn
      • Shida Eye Clinic
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8655
      • Recruiting
      • The University of Tokyo Hospital
    • Chiyoda-ku, Tokyo, Japan, 101-8309
      • Recruiting
      • Nihon University Hospital
    • Chofu, Tokyo, Japan, 182-0024
      • Recruiting
      • Chofu Eye Clinic
    • Hachioji, Tokyo, Japan, 193-0998
      • Recruiting
      • Tokyo Medical University Hachioji Medical Center
    • Itabashi-ku, Tokyo, Japan, 173-0015
      • Recruiting
      • Tokyo Metropolitan Institute for Geriatrics and Gerontology
    • Itabashi-ku, Tokyo, Japan, 174-0071
      • Recruiting
      • Tokiwadai Muranaka Eye Clinic
    • Meguro-ku, Tokyo, Japan, 152-8902
      • Recruiting
      • National Hospital Organization Tokyo Medical Center
    • Shinjuku-ku, Tokyo, Japan, 160-8582
      • Recruiting
      • Keio University Hospital
    • Shinjuku-ku, Tokyo, Japan, 162-8666
      • Recruiting
      • Tokyo Women's Medical University Hospital
  • Yamaguchi
    • Ube, Yamaguchi, Japan, 755-8505
      • Recruiting
      • Yamaguchi University Hospital
  • Yamanashi
    • Chuo, Yamanashi, Japan, 409-3898
      • Recruiting
      • University of Yamanashi Hospital
• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Not yet recruiting
    • Pusan National University Hospital
  • Daegu, Korea, Republic of, 42415
    • Not yet recruiting
    • Yeungnam University Medical Center
  • Gyeonggi-do, Korea, Republic of, 425-707
    • Not yet recruiting
    • Korea University Ansan Hospital
  • Seoul, Korea, Republic of, 05505
    • Not yet recruiting
    • Asan Medical Center
  • Seoul, Korea, Republic of, 135-710
    • Not yet recruiting
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 03722
    • Not yet recruiting
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 110-744
    • Not yet recruiting
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 150-034
    • Not yet recruiting
    • Kim's Eye Hospital
  • Seoul, Korea, Republic of, 6591
    • Not yet recruiting
    • St. Mary Hospital
  • Gyeonggido
    • Seongnam-si, Gyeonggido, Korea, Republic of, 463-707
      • Not yet recruiting
      • Seoul National University Bundang Hospital
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 6273
      • Not yet recruiting
      • Gangnam Severance Hospital, Yonsei University Health System
• Latvia
  • Riga, Latvia, 1002
    • Active, not recruiting
    • Department of Ophthalmology
  • Riga, Latvia, LV-1006
    • Active, not recruiting
    • Riga East Clinical University Hospital "Gailezers"
  • Riga, Latvia, LV-1009
    • Withdrawn
    • Latvian American Eye Center
• Lithuania
  • Kaunas, Lithuania, LT-50161
    • Active, not recruiting
    • Hospital of LT University of Health Sciences Kaunas Clinics
  • Vilnius, Lithuania, LT-08661
    • Active, not recruiting
    • Vilnius University Hospital Santaros Klinikos
• Malaysia
  • Bandar Puncak Alam, Malaysia, 42300
    • Active, not recruiting
    • Hospital Al-Sultan Abdullah, UiTM | Opthalmology
  • Kuala Lumpur, Malaysia, 59200
    • Active, not recruiting
    • OasisEye Specialists
  • Shah Alam, Malaysia, 40000
    • Active, not recruiting
    • Hospital Shah Alam | Ophthalmology
  • Shah Alam, Malaysia, 68100
    • Active, not recruiting
    • Hospital Selayang
• Mexico
  • Guadalajara, Mexico, 44670
    • Withdrawn
    • Santa Lucia Clinica | Oftalmologica
  • Mexico City, Mexico, 06800
    • Withdrawn
    • Instituto de Oftalmología FAP Conde de Valenciana, IAP. | Oftalmología
  • Mexico City, Mexico, 11850
    • Withdrawn
    • Hospital Angeles Mocel | Oftalmologia
  • Queretaro, Mexico, 76090
    • Withdrawn
    • Instituto Mexicano de Oftalmologia, IMO
  • Queretaro, Mexico, 76187
    • Withdrawn
    • Instituto de la Retina del Bajío SC
  • Distrito Federal
    • Mexico City, Distrito Federal, Mexico, 6030
      • Withdrawn
      • Fundacion Hospital Nuestra Señora de la Luz
• Poland
  • Bydgoszcz, Poland, 85-631
    • Active, not recruiting
    • Prywatna Klinika Okulistyczna OFTALMIKA
  • Bydgoszcz, Poland, 85-870
    • Active, not recruiting
    • Specjalistyczny Osrodek Okulistyczny Oculomedica
  • Gdansk, Poland, 80-402
    • Withdrawn
    • NZOZ Poradnia Okulistyczna Dobry Wzrok
  • Gdansk, Poland, 80-809
    • Active, not recruiting
    • Profesorskie Centrum Okulistyki
  • Katowice, Poland, 40-594
    • Active, not recruiting
    • Gabinet Okulistyczny Prof. Edward Wylegala
  • Krakow, Poland, 31-070
    • Active, not recruiting
    • Centrum Medyczne Dietla 19 Sp. z o.o.
  • Krakow, Poland, 31-411
    • Active, not recruiting
    • Centrum Medyczne Promed
  • Olsztyn, Poland, 10-424
    • Active, not recruiting
    • Centrum Diagnostyki i Mikrochirurgii Oka LENS
  • Rzeszow, Poland, 35-017
    • Active, not recruiting
    • Osrodek Chirurgii Oka prof. Zagorskiego Sp. z o.o.
  • Walbrzych, Poland, 58-304
    • Active, not recruiting
    • Centrum Medyczne Piasta 47
• Portugal
  • Coimbra, Portugal, 3000-548
    • Active, not recruiting
    • AIBILI
  • Coimbra, Portugal, 3000-548
    • Active, not recruiting
    • Espaco Medico de Coimbra
  • Lisboa, Portugal, 1169-050
    • Active, not recruiting
    • CHLC - Hospital dos Capuchos - Servico de Oftalmologia
  • Porto, Portugal, 4099-001
    • Withdrawn
    • Centro Hospitalar Universitario do Porto
  • Porto, Portugal, 4200-319
    • Active, not recruiting
    • CHUSJ - Hospital Sao Joao
  • Porto
    • Vila Nova de Gaia, Porto, Portugal, 4434-502
      • Active, not recruiting
      • Centro Hospitalar Vila Nova de Gaia/Espinho | Unit 1 - Clinical Research Office
• Serbia
  • Belgrade, Serbia, 11000
    • Active, not recruiting
    • Clinical Center of Serbia
  • Belgrade, Serbia, 11000
    • Active, not recruiting
    • Clinical hospital center Zvezdara
  • Novi Sad, Serbia, 21000
    • Active, not recruiting
    • Klinicki centar Vojvodine
• Slovakia
  • Banska Bystrica, Slovakia, 97517
    • Active, not recruiting
    • Fakultna nemocnica s poliklinikou F.D.Roosevelta
  • Bratislava, Slovakia, 82606
    • Active, not recruiting
    • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
  • Bratislava, Slovakia, 851 07
    • Active, not recruiting
    • Univerzitna nemocnica Bratislava, Petrzalka
  • Nitra, Slovakia, 95001
    • Active, not recruiting
    • Fakultna nemocnica Nitra
  • Poprad, Slovakia, 058 45
    • Withdrawn
    • Nemocnica Poprad, a.s.
  • Trencin, Slovakia, 911 71
    • Active, not recruiting
    • Fakultna nemocnica Trencin
  • Zvolen, Slovakia, 960 01
    • Active, not recruiting
    • Specialized hospital for ophthalmology OPHTAL
• Spain
  • Barcelona, Spain, 8036
    • Active, not recruiting
    • Hospital Clínic i Provincial de Barcelona
  • Barcelona, Spain, 08035
    • Active, not recruiting
    • Hospital Vall d'Hebron - Servei d'Oftalmologia
  • Barcelona, Spain, 8041
    • Withdrawn
    • Hospital de la Santa Creu i Sant Pau | Gynecology Department
  • Córdoba, Spain, 14004
    • Withdrawn
    • Hospital Reina Sofía
  • Pamplona, Spain, 31008
    • Withdrawn
    • Clínica Universidad de Navarra CUN
  • Valencia, Spain, 46014
    • Active, not recruiting
    • Hospital General Universitario de Valencia
  • Valladolid, Spain, 47012
    • Active, not recruiting
    • Hospital del Rio Hortega
  • Zaragoza, Spain, 50009
    • Active, not recruiting
    • Hospital Miguel Servet
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15706
      • Active, not recruiting
      • Instituto Oftalmológico Francisco Gomez Ulla
  • Barcelona
    • Sant Cugat del Vallés, Barcelona, Spain, 08195
      • Active, not recruiting
      • Hospital General de Catalunya
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Withdrawn
      • Hospital Universitario Clinica Puerta de Hierro
• Switzerland
  • Bern, Switzerland, 3010
    • Active, not recruiting
    • Inselspital Universitätsspital Bern
  • Bern, Switzerland
    • Active, not recruiting
    • Berner Augenklinik am Lindenhofspital
  • Binningen, Switzerland, 4102
    • Active, not recruiting
    • Vista Klinik
  • Lausanne, Switzerland, 1004
    • Active, not recruiting
    • University Eye Hospital Jules Gonin
  • Vaud
    • Lausanne, Vaud, Switzerland, 1006
      • Active, not recruiting
      • RétinElysée
• Thailand
  • Chiangmai, Thailand, 50200
    • Active, not recruiting
    • Chiangmai University
  • Khon Kaen, Thailand, 40002
    • Completed
    • Srinagarind Hospital
  • Pathum Thani,, Thailand, 12120
    • Withdrawn
    • Thammasat University
• Turkey
  • Adana, Turkey, 1330
    • Withdrawn
    • Cukurova Universitesi Tip Fakultesi Hastanesi
  • Ankara, Turkey, 06100
    • Completed
    • Hacettepe Universitesi Tip Fakultesi
  • Ankara, Turkey, 06170
    • Active, not recruiting
    • Ankara Etlik City Hospital | Ophthalmology
  • Ankara, Turkey, 06490
    • Withdrawn
    • Baskent Universitesi Tip Fakultesi Hastanesi
  • Ankara, Turkey, 6010
    • Active, not recruiting
    • Sbü Gülhane Eğitim Ve Araştirma Hastanesi
  • Ankara, Turkey, 6100
    • Active, not recruiting
    • Ankara Numune Egitim ve Arastirma Hastanesi
  • Ankara, Turkey, 6100
    • Withdrawn
    • Ankara Universitesi Tip Fakultesi Hastanesi
  • Ankara, Turkey, 6560
    • Withdrawn
    • Gazi Universitesi Tip Fakultesi
  • Aydin, Turkey, 9100
    • Active, not recruiting
    • Adnan Menderes Universitesi Tip fakultesi
  • Bilkent Çankaya, Turkey, 6800
    • Active, not recruiting
    • Ankara Bilkent Sehir Hastanesi
  • Istanbul, Turkey, 34093
    • Withdrawn
    • Istanbul Universitesi Istanbul Tip Fakultesi
  • Istanbul, Turkey, 34420
    • Withdrawn
    • Beyoglu Eye Training and Research Hospital
  • Izmir, Turkey, 35100
    • Withdrawn
    • Ege Universitesi Tip Fakultesi
  • Kocaeli, Turkey, 41380
    • Active, not recruiting
    • Kocaeli Universitesi Tip Fakultesi
• United Kingdom
  • Bradford, United Kingdom, BD9 6RJ
    • Active, not recruiting
    • Bradford Royal Infirmary
  • Liverpool, United Kingdom, L7 8XP
    • Active, not recruiting
    • Royal Liverpool University Hospital
  • London, United Kingdom, EC1V2PD
    • Active, not recruiting
    • Moorfields Eye Hospital
  • York, United Kingdom, YO611DW
    • Active, not recruiting
    • York Teaching Hospital
  • Essex
    • Colchester, Essex, United Kingdom, CO4 5JR
      • Withdrawn
      • Colchester General Hospital
  • Hertfordshire
    • London Borough Of Barnet, Hertfordshire, United Kingdom, EN53DJ
      • Withdrawn
      • Barnet General Hospital
  • Leicestershire
    • Leicester, Leicestershire, United Kingdom, LE1 5WW
      • Active, not recruiting
      • Leicester Royal Infirmary
  • Norfolk
    • Great Yarmouth, Norfolk, United Kingdom, NR316LA
      • Withdrawn
      • James Paget Hospital
  • Surrey
    • Epsom, Surrey, United Kingdom, KT18 7EG
      • Withdrawn
      • Epsom General Hospital
    • Frimley, Surrey, United Kingdom, GU167UJ
      • Active, not recruiting
      • Frimley Park Hospital NHS
  • Tyne And Wear
    • Sunderland, Tyne And Wear, United Kingdom, SR29HP
      • Completed
      • Sunderland Eye Infirmary
  • West Midlands
    • Coventry, West Midlands, United Kingdom, CV22DX
      • Withdrawn
      • University Hospitals Coventry and Warwickshire NHS Trust
    • Wolverhampton, West Midlands, United Kingdom, WV100QP
      • Active, not recruiting
      • New Cross Hospital
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS9 7TF
      • Active, not recruiting
      • St James' University Hospital
  • York
    • Hull, York, United Kingdom, HU32JZ
      • Active, not recruiting
      • Hull and East Yorkshire Eye Hospital Hull and East Yorkshire
• United States
  • California
    • Fullerton, California, United States, 92835
      • Active, not recruiting
      • Retina Consultants of Orange County
    • Loma Linda, California, United States, 92354
      • Active, not recruiting
      • Mountain View | Ophthalmology
    • Long Beach, California, United States, 90807
      • Active, not recruiting
      • South Coast Retina Center
    • Mountain View, California, United States, 94040
      • Active, not recruiting
      • Northern California Retina-Vitreous Associates
    • Palm Springs, California, United States, 92262
      • Active, not recruiting
      • Southern California Desert Retina Consultants
    • Pasadena, California, United States, 91107
      • Active, not recruiting
      • California Eye Specialists
    • Riverside, California, United States, 92505
      • Withdrawn
      • Southern California Permanente Medical Group
    • Stanford, California, United States, 94305
      • Withdrawn
      • Stanford University
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Active, not recruiting
      • Retina Consultants of Southern Colorado, PC
  • Connecticut
    • New London, Connecticut, United States, 06320
      • Active, not recruiting
      • New England Retina Associates
  • Florida
    • Deerfield Beach, Florida, United States, 33064
      • Active, not recruiting
      • Rand Eye Institute
    • Fort Myers, Florida, United States, 33912
      • Active, not recruiting
      • National Ophthalmic Research Institute
    • Largo, Florida, United States, 33770
      • Completed
      • Eye Institute of West Florida
    • Melbourne, Florida, United States, 32901
      • Active, not recruiting
      • Florida Eye Associates
    • Orlando, Florida, United States, 32806
      • Recruiting
      • Florida Retina Institute
    • Pensacola, Florida, United States, 32503
      • Completed
      • Retina Specialists
    • Plantation, Florida, United States, 33324
      • Active, not recruiting
      • Fort Lauderdale Eye Institute
    • Saint Petersburg, Florida, United States, 33711-1141
      • Active, not recruiting
      • Retina Vitreous Associates of Florida - Saint Petersburg
    • Stuart, Florida, United States, 34994-2579
      • Active, not recruiting
      • East Florida Eye Institute
    • Tampa, Florida, United States, 33612
      • Withdrawn
      • University of South Florida
    • Winter Haven, Florida, United States, 33880
      • Active, not recruiting
      • Center for Retina and Macular Disease
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Active, not recruiting
      • Marietta Eye Clinic
  • Illinois
    • Chicago, Illinois, United States, 60637-1447
      • Withdrawn
      • University of Chicago
    • Elmhurst, Illinois, United States, 60126
      • Active, not recruiting
      • Retina Associates IL
    • Oak Forest, Illinois, United States, 60452
      • Active, not recruiting
      • University Retina and Macula Associates
  • Kansas
    • Lenexa, Kansas, United States, 66215
      • Active, not recruiting
      • Retina Associates, LLC
  • Maryland
    • Baltimore, Maryland, United States, 21209
      • Active, not recruiting
      • Retina Care Center
    • Hagerstown, Maryland, United States, 21740-5940
      • Active, not recruiting
      • Cumberland Valley Retina Consultants, PC
    • Hagerstown, Maryland, United States, 21740
      • Active, not recruiting
      • Mid Atlantic Retina Specialists
  • Michigan
    • Grand Rapids, Michigan, United States, 49525
      • Completed
      • Vitreo-Retinal Associates, PC
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55416
      • Active, not recruiting
      • Retina Consultants of Minnesota
  • Nevada
    • Las Vegas, Nevada, United States, 89144
      • Active, not recruiting
      • Retina Consultants of Nevada
    • Reno, Nevada, United States, 89502
      • Withdrawn
      • Sierra Eye Associates
  • New Jersey
    • Bloomfield, New Jersey, United States, 07003
      • Active, not recruiting
      • Retina Center of New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Active, not recruiting
      • NJ Retina
    • Teaneck, New Jersey, United States, 07666
      • Active, not recruiting
      • NJ Retina | Teaneck
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109-5853
      • Active, not recruiting
      • Eye Associates of New Mexico
  • New York
    • Great Neck, New York, United States, 11021
      • Active, not recruiting
      • Long Island Vitreoretinal Consultants
    • Hauppauge, New York, United States, 11788
      • Active, not recruiting
      • Long Island Vitreoretinal Consultants - Hauppauge
    • Lynbrook, New York, United States, 11563
      • Withdrawn
      • Ophthalmic Consultants of Long Island
    • Rochester, New York, United States, 14620-4655
      • Active, not recruiting
      • Retina Associates of Western New York
    • Troy, New York, United States, 12180
      • Withdrawn
      • Ophthalmic Consultants of the Capital Region
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Active, not recruiting
      • University of NC at Chapel Hill (UNC) Ophthalmology
    • Winston-Salem, North Carolina, United States, 27157
      • Withdrawn
      • Wake Forest Baptist Health
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Active, not recruiting
      • Cincinnati Eye Institute
    • Dublin, Ohio, United States, 43016
      • Active, not recruiting
      • Midwest Retina - Main Office
  • Oregon
    • Salem, Oregon, United States, 97302-2152
      • Active, not recruiting
      • Retina Consultants, LLC
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Withdrawn
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Active, not recruiting
      • Mid Atlantic Retina
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Active, not recruiting
      • Retina Consultants of Charleston
    • Florence, South Carolina, United States, 29501
      • Withdrawn
      • Palmetto Retina Center, LLC - Florence
    • West Columbia, South Carolina, United States, 29169
      • Active, not recruiting
      • Palmetto Retina Center, LLC
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Completed
      • Charles Retina Institute
  • Texas
    • Austin, Texas, United States, 78705
      • Active, not recruiting
      • Austin Retina Associates
    • Bellaire, Texas, United States, 77401
      • Active, not recruiting
      • Retinal Consultants of Texas - Bellaire
    • Fort Worth, Texas, United States, 76104
      • Active, not recruiting
      • Texas Retina Associates
    • San Antonio, Texas, United States, 78240
      • Active, not recruiting
      • Medical Center Ophthalmology Associates
    • San Antonio, Texas, United States, 78240
      • Active, not recruiting
      • Retinal Consultants of Texas - San Antonio
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Completed
      • Rocky Mountain Retina Consultant
  • Virginia
    • Virginia Beach, Virginia, United States, 22031
      • Active, not recruiting
      • The Retina Group of Washington | Fairfax
  • Washington
    • Spokane, Washington, United States, 99204
      • Active, not recruiting
      • Spokane Eye Clinical Research
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Completed
      • University of Wisconsin - Madison

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 64		From baseline to Week 64
Number of active injections from baseline to Week 36		From baseline to Week 36
Number of participants gaining at least 15 letters in BCVA from baseline at Weeks 36 and 64		From baseline at week 36 and week 64
Participant having no IRF and no SRF in the center subfield at Weeks 36 and 64 (yes/no)		At week 36 and week 64
Number of participant with TEAEs and SAEs through Weeks 36 and 64		Through weeks 36 and 64
Participants dosed only Q8W through Week 36 in the 8 mg Q8W group		Through weeks 36
Participants having last treatment intervals ≥12 or of 16 weeks at Week 64		At week 64
Participants having next intended interval ≥12 or of 16 weeks at Week 64		At week 64
Systemic exposure to aflibercept as assessed by plasma concentrations of free, adjusted bound and total aflibercept from baseline through Weeks 36 and 64		From baseline through weeks 36 and 64
Change from baseline in BCVA measured by the ETDRS letter score at Week 44	ETDRS letter score (ranging from 0 to 100 letters). A higher letter score means a better outcome (better visual acuity)	At baseline, week 44
Change from baseline in BCVA measured by the ETDRS letter score at Week 64	ETDRS letter score (ranging from 0 to 100 letters). A higher letter score means a better outcome (better visual acuity)	At baseline, week 64
Number of participant achieving an ETDRS letter score of at least 69 (approximate 20/40 Snellen equivalent) at Weeks 36 and 64	ETDRS letter score (ranging from 0 to 100 letters). A higher letter score means a better outcome (better visual acuity)	At week 36 and week 64
Change from baseline in CST at Weeks 36 and 64	CST: Central Sub-field Thickness;	At baseline, week 36 and week 64
Change from baseline in NEI VFQ 25 total score at Weeks 36 and 64	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).	At baseline, week 36 and week 64

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 (Estimated): November 29, 2024
• Study Completion (Estimated): May 16, 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): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Neoplasms; Eye Diseases; Retinal Degeneration; Retinal Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Neoplastic Processes; Macular Degeneration; Macular Edema; Retinal Vein Occlusion; Neoplasm Metastasis; Edema; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• 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