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)

PHASE3CompletedINTERVENTIONAL
Enrollment

892

Participants

Timeline

Start Date

May 15, 2023

Primary Completion Date

November 7, 2024

Study Completion Date

May 27, 2025

Conditions
Macular Edema Secondary to Retinal Vein Occlusion
Interventions
DRUG

Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose

Intravitreally (IVT) injection.

DRUG

Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_2 mg

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.

Trial Locations (273)

0

Uni Heidelberg / Augenklinik, Heidelberg

114

"LTD Chichua Medical Center MZERA", Tbilisi

198

Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia, Rome

1002

Department of Ophthalmology, Riga

1004

University Eye Hospital Jules Gonin, Lausanne

1006

RétinElysée, Lausanne

1062

Magyar Honvedseg Egeszsegugyi Kozpont, Budapest

1083

University of Semmelweis/ Semmelweis Egyetem, Budapest

1090

Universitätsklinikum AKH Wien, Vienna

1106

Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet, Budapest

1133

Budapest Retina Associates, Budapest

1140

Hanusch-Krankenhaus Wien, Vienna

1309

SEHAT Pentagram, Sofia

1784

Specialized Hospital For Active Treatment of Eye Diseases Zora, Sofia

2000

Sydney Eye Hospital, Sydney

Sydney Retina Clinic, Sydney

2135

Strathfield Retina Clinic, Strathfield

2145

Sydney West Retina Pty Ltd, Westmead

2150

Marsden Eye Surgery Center, Parramatta

2640

Eyeclinic Albury Wodonga, Albury

3002

Centre for Eye Research, East Melbourne

3010

Inselspital Universitätsspital Bern, Bern

3080

Seoul National University Hospital, Seoul

4021

Konventhospital Barmherzige Brüder Linz, Linz

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

4102

Vista Klinik, Binningen

5000

Adelaide Eye and Retina Centre, Adelaide

6009

Lion Eye Institute, Nedlands

6010

SBU Gulhane Egitim ve Arastirma Hastanesi, Ankara

6100

Ankara Numune Egitim ve Arastirma Hastanesi, Ankara

Hacettepe Universitesi Tip Fakultesi, Ankara

6273

Gangnam Severance Hospital, Yonsei University Health System, Seoul

6720

SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont, Szeged

6800

Ankara Bilkent Sehir Hastanesi, Bilkent Ankara

7000

Hobart Eye Surgeons, Hobart

7621

Ganglion Medical Center, Pécs

8025

Hospital de la Santa Creu i de Sant Pau, Barcelona

8036

Medizinische Universität Graz, Graz

Hospital Clínic i Provincial de Barcelona, Barcelona

9000

Spec. Hosp. of Ophthalm. Disease for Active Treatment Varna, Varna

9020

Klinikum Klagenfurt am Wörthersee, Klagenfurt

9100

Adnan Menderes Universitesi Tip fakultesi, Aydin

10034

Fakultní nemocnice Královské Vinohrady - Urologická klinikay, Prague

10138

AS Ida-Tallinna Keskhaigla - Oftalmoloogiakeskus, Tallinn

11000

Clinical Center of Serbia, Belgrade

Clinical hospital center Zvezdara, Belgrade

11021

Long Island Vitreoretinal Consultants - Great Neck, Great Neck

11412

Dr. Kai Noor Silmakabinet OÜ, Tallinn

11563

Ophthalmic Consultants of Long Island, Lynbrook

11788

Vitreoretinal Consultants of NY - Hauppauge, Hauppauge

12808

Všeobecná fakultní nemocnice v Praze, Prague

13008

Centre d'Ophtalmologie - Paradis-Monticelli, Marseille

13620

Seoul National University Bundang Hospital, Seongnam-si

14620

Retina Associates of Western New York, Rochester

15706

Instituto Oftalmologico Gomez-Ulla S.L. - Oftalmologia, Santiago de Compostela

19107

Mid Atlantic Retina - Philadelphia / Wills Eye Hospital, Philadelphia

20122

ASST Fatebenefratelli Sacco, Milan

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

20132

Ospedale San Raffaele s.r.l., Milan

21000

CHU Dijon - Hopital Francois Miterrand, Dijon

Klinicki centar Vojvodine, Novi Sad

21209

Retina Care Center, Baltimore

21740

Mid Atlantic Retina Specialists - Hagerstown, Hagerstown

28222

Hospital Universitario Puerta De Hierro De Majadahonda - Oftalmologia, Majadahonda

29456

Retina Consultants of South Carolina - Ladson, Ladson

29501

Palmetto Retina Center, LLC - Florence, Florence

30060

Marietta Eye Clinic, Marietta

31008

Clínica Universidad de Navarra CUN, Pamplona

32503

Retina Specialty Institute - Pensacola, Pensacola

32806

Florida Retina Institute - Orlando, Orlando

32901

Florida Eye Associates - Melbourne Main Office, Melbourne

33000

Clinique Rétine Tourny, Bordeaux

33064

Rand Eye Institute, Deerfield Beach

33076

CHU Bordeaux - Hopital Pellegrin - Ophtalmologie, Bordeaux

33324

Fort Lauderdale Eye Institute, Plantation

33711

Retina Vitreous Associates of Florida - Saint Petersburg, St. Petersburg

33770

The Eye Institute of West Florida, Largo

33880

Center for Retina and Macular Disease - Winter Haven, Winter Haven

33912

National Ophthalmic Research Institute - Fort Myers, Fort Myers

34994

East Florida Eye Institute, Stuart

37000

Centre Ophtalmologique Transparence - Tours, Tours

38119

Charles Retina Specialists - Germantown, Memphis

40002

Srinagarind Hospital, Khon Kaen

41380

Kocaeli Universitesi Tip Fakultesi, Kocaeli

42415

Yeungnam University Medical Center, Daegu

43016

Midwest Retina - Main Office, Dublin

44000

Clinique Jules Verne - Nantes, Nantes

46014

Hospital General Universitario de Valencia, Valencia

47012

Hospital Universitario Rio Hortega - Oftalmologia, Valladolid

48145

St. Franziskus-Hospital Münster - Eye Center, Münster

49241

Pusan National University Hospital, Busan

49525

Vitreo-Retinal Associates, PC, Grand Rapids

50000

Shijiazhuang General Hospital, Shijiazhuang

50009

Hospital Universitario Miguel Servet - Oftalmologia, Zaragoza

50200

Chiangmai University, Chiang Mai

50406

Sihtasutus Tartu Ülikooli Kliinikum - Silmakliinik, Tartu

53127

Uniklinik Bonn / Eye Clinic, Bonn

53792

University of Wisconsin - Madison, Madison

55416

RCM - St. Louis Park Retina Clinic, Saint Louis Park

59200

OasisEye Specialists, Kuala Lumpur

60126

Retina Associates - Elmhurst, Elmhurst

Azienda Ospedaliero Universitaria Delle Marche - Clinica Oculistica, Torrette

60452

University Retina and Macula Associates, Oak Forest

66215

Retina Associates - Lenexa, Lenexa

66280

Knappschaftskrankenhaus Sulzbach, Sulzbach

67000

CM Wolff, Strasbourg

67063

Klinikum d. Stadt Ludwigshafen - Ophthalmology, Ludwigshafen

68100

Hospital Selayang, Shah Alam

69004

Hôpital de la Croix Rousse, Lyon

75006

Centre d'ophtalmologie de l'Odéon, Paris

75015

Centre Ophthalmologie d'Imagerie et de Laser, Paris

75475

AP-HP - Hopital Lariboisiere, Paris

75557

Centre Hospitalier National d'Ophthalmologie Quinze-Vingt, Paris

76104

Texas Retina Associates, Fort Worth

77401

Retina Consultants of Texas - Bellaire, Bellaire

78240

Medical Center Ophthalmology Associates - Northwest, San Antonio

Retina Consultants of Texas - San Antonio Medical Center, San Antonio

78705

Austin Retina Associates - Central, Austin

80909

Retina Consultants of Southern Colorado, PC, Colorado Springs

84107

Rocky Mountain Retina Consultants - Main Office, Salt Lake City

87109

Eye Associates of New Mexico - Albuquerque - Retina Center, Albuquerque

89144

Retina Consultants of Nevada - Summerlin, Las Vegas

90807

South Coast Retina - Long Beach, Long Beach

91107

Azul Vision Pasadena, Pasadena

92262

Southern California Desert Retina Consultants - Palm Springs Office, Palm Springs

92374

Retina Consultants of Southern California, Redlands

92835

Retina Consultants of Orange County - Fullerton, Fullerton

94010

Hôpital Intercommunal - Créteil Cedex, Créteil

94040

Northern California Retina Vitreous Associates - Mountain View Office, Mountain View

96001

Specialized hospital for ophthalmology OPHTAL, Zvolen

97302

Retina Consultants, LLC, Salem

97517

Fakultna Nemocnica s poliklinikou F.D.Roosevelta, Banská Bystrica

99204

Spokane Eye Clinical Research, Spokane

100000

Beijing Aier Intech Eye Hospital, Beijing

100029

China-Japan Friendship Hospital, Beijing

100034

Peking University First Hospital, Beijing

100062

Capital Medical University (CMU) - Beijing Tongren Hospital, Beijing

100730

Beijing Hospital, Beijing

Peking Union Medical College Hospital CAMS, Beijing

110082

The Fourth People's Hospital of Shenyang, Shenyang

130022

Eye Center of the second Bethune Hospital, jinlin University, Changchun

230601

The Second Hospital of Anhui medical university, Hefei

250000

Qilu Hosp., Shandong Univ., Jinan

300384

Tianjin Medical University Eye Hospital, Tianjin

310014

ZheJiang Provincial People's Hospital, Hangzhou

322199

Dongyang People's Hospital, Jinhua

400020

Chongqing Aier Ophthalmology Hospital, Chongqing

430030

Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech., Wuhan

450008

Henan Provincial Eye Hospital, Henan

634050

Guangzhou Aier Eye Hospital, Guangzhou

730030

Lanzhou University - The Second Hospital (The Second Clinical Medical College of Lanzhou University), Lanzhou

750002

People's Hospital of Ningxia Hui Autonomous Region - Opthalmology, Ningxia

3109601

Rambam Health Corporation, Haifa

3436212

Lady Davis Carmel Medical Center, Haifa

4428164

Meir Medical Center, Kfar Saba

6423906

Tel-Aviv Sourasky Medical Center, Tel Aviv

6789140

Assuta Medical Centers - HaShalom, Tel Aviv

7030000

Shamir Medical Center (Assaf Harofeh), Ẕerifin

7610001

Kaplan Medical Center, Rehovot

9112001

Hadassah Hebrew University Hospital Ein Kerem, Jerusalem

06320

New England Retina Associates, New London

Maryland

"Cumberland Valley Retina Consultants , Hagerstown, MD"

07003

Retina Center of New Jersey, Bloomfield

08901

NJ Retina - New Brunswick, New Brunswick

New Jersey

"NJ Retina , Teaneck"

North Carolina

"University of North Carolina at Chapel Hill (UNC) , Ophthalmology"

45242-5664

Cincinnati Eye Institute - Blue Ash, Blue Ash

Virginia

"The Retina Group of Washington , Fairfax"

050010

Hebei eye hospital, Hebei

Unknown

Aier Eye Hospital (LIAONING), Shenyang

Aier Eye Hospital (Chengdu), Chengdu

"Clalit Health , Soroka Medical Center - Internal Medicine Department"

"Edith Wolfson Medical Center , Internal Medicine Department"

"Rabin Medical Center , Beilinson Hospital - Internal Medicine C Department"

"Centro Hospitalar Universitario de Sao Joao , Polo Porto - Centro de Investigacao e Ensaios Clinicos"

"Centro Hospitalar Vila Nova de Gaia e Espinho , Unit 1 - Clinical Research Center"

"Ankara Etlik City Hospital , Ophthalmology"

030002

Shanxi Eye Hospital, Shanxi

500 05

Fakultní Nemocnice Hradec Kralové, Hradec Králové

708 52

Fakultní nemocnice Ostrava, Ostrava

530 03

Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice, Pardubice

140 00

Lexum a.s., Evropska ocni klinika, Prague

150 00

Axon Clinical, s.r.o., Prague

0162

"LTD IQ Clinic- Ophthalmology", Tbilisi

00133

Azienda Ospedaliera Policlinico Universitario Tor Vergata - Patologie Retiniche, Rome

00136

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oculistica, Rome

480-1195

Aichi Medical University Hospital, Nagakute

467-8602

Nagoya City University Hospital, Nagoya

286-8520

International University of Health and Welfare Narita Hospital, Narita

285-8741

Toho University Sakura Medical Center, Sakura

910-1193

University of Fukui Hospital, Yoshida

830-0011

Kurume University Hospital, Kurume

963-8052

Southern Tohoku Eye Clinic, Kōriyama

371-8511

Gunma University Hospital, Maebashi

660-8550

Hyogo Prefectural Amagasaki General Medical Center, Amagasaki

650-0017

Kobe University Hospital, Kobe

663-8501

Hyogo Medical University Hospital, Nishinomiya

310-0845

Kozawa Eye Hospital and Diabetes Center, Mito

302-0014

Matsumoto Eye Clinic, Toride

761-0793

Kagawa University Hospital, Kita-gun

211-0053

Medical corporation Eiwakai Dannoue Ophthalmology clinic, Kawasaki

216-8511

St. Marianna University Hospital, Kawasaki

232-0024

Yokohama City University Medical Center, Yokohama

514-8507

Mie University Hospital, Tsu

390-8621

Shinshu University Hospital, Matsumoto

359-8513

National Defense Medical College Hospital, Tokorozawa

520-2192

Shiga University of Medical Science Hospital, Ōtsu

426-0029

Shida Eye Clinic, Fujieda-shi

101-8309

Nihon University Hospital, Chiyoda-ku

113-8655

The University of Tokyo Hospital, Bunkyo-ku

182-0024

Chofu Eye Clinic, Chōfu

193-0998

Tokyo Medical University Hachioji Medical Center, Hachiōji

173-0015

Tokyo Metropolitan Institute for Geriatrics and Gerontology, Itabashi-ku

174-0071

Tokiwadai Muranaka Eye Clinic, Itabashi-ku

152-8902

National Hospital Organization Tokyo Medical Center, Meguro-ku

160-8582

Keio University Hospital, Shinjuku-ku

162-8666

Tokyo Women's Medical University Hospital, Shinjuku-ku

755-8505

Yamaguchi University Hospital, Ube

409-3898

University of Yamanashi Hospital, Chūō

010-8543

Akita University Hospital, Akita

812-0011

Hayashi Eye Hospital, Fukuoka

819-8585

Murakami Karindoh Hospital, Fukuoka

960-1295

Fukushima Medical University Hospital, Fukushima

890-8520

Kagoshima University Hospital, Kagoshima

889-1692

University of Miyazaki Hospital, Miyazaki

852-8511

Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki

700-8558

Okayama University Hospital, Okayama

545-8586

Osaka Metropolitan University Hospital, Osaka

330-8553

Japanese Red Cross Saitama Hospital, Saitama

930-0194

Toyama University Hospital, Toyama

640-8558

Japanese Red Cross Wakayama Medical Center, Wakayama

990-9585

Yamagata University Hospital, Yamagata

LV-1038

"Riga East Clinical University Hospital Gailezers", Riga

LT-50161

Hospital of LT University of Health Sciences Kaunas Clinics, Kaunas

LT-08661

Vilnius University Hospital Santaros Klinikos, Vilnius

Selangor

"Hospital Al-Sultan Abdullah, UiTM , Opthalmology"

"Hospital Shah Alam , Ophthalmology"

85-631

Prywatna Klinika Okulistyczna OFTALMIKA, Bydgoszcz

85-870

Specjalistyczny Osrodek Okulistyczny Oculomedica, Bydgoszcz

80-809

Profesorskie Centrum Okulistyki, Gdansk

40-594

Gabinet Okulistyczny Prof. Edward Wylegala, Katowice

31-070

Centrum Medyczne Dietla 19 Sp. z o.o., Krakow

31-411

Centrum Medyczne PROMED, Krakow

10-424

Centrum Diagnostyki i Mikrochirurgii Oka Lens, Olsztyn

35-017

Osrodek Chirurgii Oka prof. Zagorskiego Sp. z o.o., Rzeszów

58-304

Centrum Medyczne Piasta 47, Wałbrzych

3000-548

AIBILI, Coimbra

Espaco Medico de Coimbra, Coimbra

1169-050

CHLC - Hospital dos Capuchos - Servico de Oftalmologia, Lisbon

4099-001

Centro Hospitalar Universitario do Porto, Porto

826 06

Univerzitna nemocnica Bratislava, Nemocnica Ruzinov, Bratislava

851 07

Univerzitna nemocnica Bratislava, Nem. Sv. Cyrila a Metoda, Bratislava

950 01

Fakultna nemocnica Nitra, Nitra

911 71

Fakultna nemocnica Trencin, Trenčín

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

425-707

Korea University Ansan Hospital, Gyeonggi-do

06351

Samsung Medical Center, Seoul

137-701

St. Mary Hospital, Seoul

150-034

Kim's Eye Hospital, Seoul

08195

Hospital General de Catalunya - Oftalmologia, Sant Cugat del Vallès

08035

Hospital Vall d'Hebron - Servei d'Oftalmologia, Barcelona

TBC

Berner Augenklinik am Lindenhofspital, Bern

LE1 5WW

Leicester Royal Infirmary, Leicester

GU167UJ

Frimley Park Hospital NHS, Frimley

SR29HP

Sunderland Eye Infirmary, Sunderland

WV100QP

New Cross Hospital, Wolverhampton

BD9 6RJ

Bradford Royal Infirmary, Bradford

West Yorkshire

"Leeds Teaching Hospitals NHS Trust , St James's University Hospital - Oncology"

HU32JZ

Hull and East Yorkshire Eye Hospital Hull and East Yorkshire, Hull

L7 8XP

Royal Liverpool University Hospital, Liverpool

EC1V2PD

Moorfields Eye Hospital, London

YO611DW

York Teaching Hospital, York

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Bayer

INDUSTRY

NCT05850520 - 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) | Biotech Hunter | Biotech Hunter