AzTrials
AzTrials

Macular Edema Secondary to Retinal Vein OcclusionPhase 3QUASARNCT05850520

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)

A Phase 3 study testing Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose, Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_2 mg and Fluorescein in people with Macular Edema Secondary to Retinal Vein Occlusion, run by Bayer at 273 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose, Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_2 mg and Fluorescein
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
892 participants
Where
273 sitesin 27 countries
Study dates
15 May 2023to 27 May 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
  • Advanced age-related macular degeneration (neovascular AMD or geographic atrophy) in the study eye.
  • 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.
  • Anterior segment neovascularization, vitreous hemorrhage, retinal detachment in the study eye.
  • 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.
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  • Macular hole of stage 2 and above in the study eye.
  • Myopia of a spherical equivalent of at least 8 diopters prior to any refractive or cataract surgery in the study eye.
  • Corneal transplant or corneal dystrophy in the study eye.
  • Idiopathic or autoimmune uveitis in the study or in the fellow eye.
  • Presence of the following ocular conditions at screening or baseline visit:
  • Significant media opacities, including cataract, that interfere with BCVA, or imaging assessments (e.g., fundus photography [FP], OCT) in the study eye.
  • 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.
  • 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.
  • 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.
  • 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:
  • Anti-angiogenic drugs at any time including investigational therapy (e.g., with anti-angiopoietin/anti-VEGF bispecific monoclonal antibodies).
  • 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.
  • Previous treatment with intraocular or periocular implant, gene therapy, or cell therapy at any time.
  • Treatment with ocriplasmin at any time.
  • Vitreoretinal surgery (including scleral buckling) at any time.
  • Any intraocular surgery, including cataract surgery, within 12 weeks (84 days) before the screening visit.
  • Previous treatment with retinal laser photocoagulation.
  • Prior treatment of the fellow eye with any of the following:
  • 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.

Trial locations and contacts

273 sites in 27 countries.

273 sites in 27 countries

United States53 sites

  • Vision Research Center

    Albuquerque, New Mexico, 87109

  • Austin Retina Associates - Central

    Austin, Texas, 78705

  • The Retina Care Center - Baltimore

    Baltimore, Maryland, 21209

  • Retina Consultants of Texas - Bellaire

    Bellaire, Texas, 77401

  • Mid Atlantic Retina - Bethlehem

    Bethlehem, Pennsylvania, 18107

  • Retina Center of New Jersey

    Bloomfield, New Jersey, 07003

  • Cincinnati Eye Institute - Blue Ash

    Blue Ash, Ohio, 45242

  • Retina Consultants of Southern Colorado, PC

    Colorado Springs, Colorado, 80909

  • Rand Eye Institute

    Deerfield Beach, Florida, 33064

  • Midwest Retina - Main Office

    Dublin, Ohio, 43016

  • Retina Associates - Elmhurst

    Elmhurst, Illinois, 60126

  • The Retina Group of Washington - Fairfax

    Fairfax, Virginia, 22031

  • Palmetto Retina Center, LLC - Florence

    Florence, South Carolina, 29501

  • National Ophthalmic Research Institute - Fort Myers

    Fort Myers, Florida, 33912

  • Texas Retina Associates - Fort Worth

    Fort Worth, Texas, 76104

  • Retina Consultants of Orange County - Fullerton

    Fullerton, California, 92835

  • Vitreo-Retinal Associates - Worcester

    Grand Rapids, Michigan, 49525

  • Vitreoretinal Consultants of NY - Great Neck

    Great Neck, New York, 11021

  • Cumberland Valley Retina Consultants | Hagerstown, MD

    Hagerstown, Maryland, 21740

  • Mid Atlantic Retina Specialists - Hagerstown

    Hagerstown, Maryland, 21740

  • Vitreoretinal Consultants of NY - Hauppauge

    Hauppauge, New York, 11788

  • Retina Consultants of South Carolina - Ladson

    Ladson, South Carolina, 29456

  • The Eye Institute of West Florida - Largo

    Largo, Florida, 33770

  • Retina Consultants of Nevada - Summerlin

    Las Vegas, Nevada, 89144

  • Retina Associates - Lenexa

    Lenexa, Kansas, 66215

  • South Coast Retina - Long Beach

    Long Beach, California, 90807

  • Ophthalmic Consultants of Long Island

    Lynbrook, New York, 11563

  • UW Health Carbone Cancer Center

    Madison, Wisconsin, 53792

  • Marietta Eye Clinic

    Marietta, Georgia, 30060

  • Florida Eye Associates - Melbourne Main Office

    Melbourne, Florida, 32901

  • Charles Retina Specialists - Germantown

    Memphis, Tennessee, 38119

  • Northern California Retina Vitreous Associates - Mountain View Office

    Mountain View, California, 94040

  • NJ Retina - New Brunswick

    New Brunswick, New Jersey, 08901

  • New England Retina Associates

    New London, Connecticut, 06320

  • University Retina and Macula Associates - Oak Forest

    Oak Forest, Illinois, 60452

  • Florida Retina Institute - Orlando

    Orlando, Florida, 32806

  • Desert Retina Consultants - Palm Springs Office

    Palm Springs, California, 92262

  • Azul Vision Pasadena

    Pasadena, California, 91107

  • Retina Specialty Institute - Pensacola

    Pensacola, Florida, 32503

  • Mid Atlantic Retina - Philadelphia / Wills Eye Hospital

    Philadelphia, Pennsylvania, 19107

  • Fort Lauderdale Eye Institute

    Plantation, Florida, 33324

  • Retina Consultants of Southern California

    Redlands, California, 92374

  • Retina Associates of Western New York

    Rochester, New York, 14620

  • RCM - St. Louis Park Retina Clinic

    Saint Louis Park, Minnesota, 55416

  • Retina Consultants, LLC

    Salem, Oregon, 97302

  • Rocky Mountain Retina Consultants - Main Office

    Salt Lake City, Utah, 84107

  • Medical Center Ophthalmology Associates - Northwest

    San Antonio, Texas, 78240

  • Retina Consultants of Texas - San Antonio Medical Center

    San Antonio, Texas, 78240

  • Spokane Eye Clinical Research - South Hill / Downtown

    Spokane, Washington, 99204

  • Retina Vitreous Associates of Florida - Saint Petersburg

    St. Petersburg, Florida, 33711

  • East Florida Eye Institute

    Stuart, Florida, 34994

  • NJ Retina | Teaneck

    Teaneck, New Jersey, 07666

  • Center for Retina and Macular Disease - Winter Haven

    Winter Haven, Florida, 33880

Other trials in United States

Japan46 sites

  • Akita University Hospital

    Akita, Akita, 010-8543

  • Hyogo Prefectural Amagasaki General Medical Center

    Amagasaki, Hyōgo, 660-8550

  • The University of Tokyo Hospital

    Bunkyo-ku, Tokyo, 113-8655

  • Nihon University Hospital

    Chiyoda-ku, Tkyo, 101-8309

  • Chofu Eye Clinic

    Chōfu, Tokyo, 182-0024

  • University of Yamanashi Hospital

    Chūō, Yamanashi, 409-3898

  • Shida Eye Clinic

    Fujieda-shi, Shizuoka, 426-0029

  • Hayashi Eye Hospital

    Fukuoka, Fukuoka, 812-0011

  • Murakami Karindoh Hospital

    Fukuoka, Fukuoka, 819-8585

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295

  • Tokyo Medical University Hachioji Medical Center

    Hachiōji, Tokyo, 193-0998

  • Tokyo Metropolitan Institute for Geriatrics and Gerontology

    Itabashi-ku, Tokyo, 173-0015

  • Tokiwadai Muranaka Eye Clinic

    Itabashi-ku, Tokyo, 174-0071

  • Kagoshima University Hospital

    Kagoshima, Kagoshima-ken, 890-8520

  • Medical corporation Eiwakai Dannoue Ophthalmology clinic

    Kawasaki, Kanagawa, 211-0053

  • St. Marianna University Hospital

    Kawasaki, Kanagawa, 216-8511

  • Kagawa University Hospital

    Kita-gun, Kagawa-ken, 761-0793

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017

  • Southern Tohoku Eye Clinic

    Kōriyama, Fukushima, 963-8052

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011

  • Gunma University Hospital

    Maebashi, Gunma, 371-8511

  • Shinshu University Hospital

    Matsumoto, Nagano, 390-8621

  • National Hospital Organization Tokyo Medical Center

    Meguro-ku, Tokyo, 152-8902

  • Kozawa Eye Hospital and Diabetes Center

    Mito, Ibaraki, 310-0845

  • University of Miyazaki Hospital

    Miyazaki, Miyazaki, 889-1692

  • Aichi Medical University Hospital

    Nagakute, Aichi-ken, 480-1195

  • Japanese Red Cross Nagasaki Genbaku Hospital

    Nagasaki, Nagasaki, 852-8511

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • International University of Health and Welfare Narita Hospital

    Narita, Chiba, 286-8520

  • Hyogo Medical University Hospital

    Nishinomiya, Hyōgo, 663-8501

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558

  • Osaka Metropolitan University Hospital

    Osaka, Osaka, 545-8586

  • Shiga University of Medical Science Hospital

    Ōtsu, Shiga, 520-2192

  • Japanese Red Cross Saitama Hospital

    Saitama, Saitama, 330-8553

  • Toho University Sakura Medical Center

    Sakura, Chiba, 285-8741

  • Keio University Hospital

    Shinjuku-ku, Tokyo, 160-8582

  • Tokyo Women's Medical University Hospital

    Shinjuku-ku, Tokyo, 162-8666

  • National Defense Medical College Hospital

    Tokorozawa, Saitama, 359-8513

  • Matsumoto Eye Clinic

    Toride, Ibaraki, 302-0014

  • Toyama University Hospital

    Toyama, Toyama, 930-0194

  • Mie University Hospital

    Tsu, Mie-ken, 514-8507

  • Yamaguchi University Hospital

    Ube, Yamaguchi, 755-8505

  • Japanese Red Cross Wakayama Medical Center

    Wakayama, Wakayama, 640-8558

  • Yamagata University Hospital

    Yamagata, Yamagata, 990-9585

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

  • University of Fukui Hospital

    Yoshida, Fukui, 910-1193

Other trials in Japan

China24 sites

  • Beijing Aier Intech Eye Hospital

    Beijing, Beijing Municipality, 100000

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029

  • Peking University First Hospital - Oncology Department

    Beijing, Beijing Municipality, 100034

  • Capital Medical University (CMU) - Beijing Tongren Hospital

    Beijing, Beijing Municipality, 100062

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

  • Peking Union Medical College Hospital CAMS

    Beijing, Beijing Municipality, 100730

  • Eye Center of the second Bethune Hospital, jinlin University

    Changchun, Jilin, 130022

  • Aier Eye Hospital (Chengdu)

    Chengdu, Sichuan, 610093

  • Chongqing Aier Ophthalmology Hospital

    Chongqing, Chongqing Municipality, 400020

  • Guangzhou Aier Eye Hospital

    Guangzhou, Guangdong, 634050

  • ZheJiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014

  • Hebei eye hospital

    Hebei, Hebei, 050010

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230601

  • Henan Provincial Eye Hospital

    Henan, Henan, 450008

  • Qilu Hosp., Shandong Univ.

    Jinan, Shandong, 250012

  • Dongyang People's Hospital

    Jinhua, Zhejiang, 322199

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

    Lanzhou, Gansu, 730030

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

    Ningxia, Ningxia, 750002

  • Shanxi Eye Hospital

    Shanxi, Shanxi, 030002

  • Aier Eye Hospital (LIAONING)

    Shenyang, Liaoning, 110003

  • The Fourth People's Hospital of Shenyang

    Shenyang, Liaoning, 110082

  • Shijiazhuang General Hospital

    Shijiazhuang, Hebei, 050000

  • Tianjin Medical University Eye Hospital

    Tianjin, Tianjin Municipality, 300384

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

    Wuhan, Hubei, 430030

Other trials in China

France13 sites

  • Clinique Rétine Tourny

    Bordeaux, New Aquitaine, 33000

  • CHU Bordeaux - Hopital Pellegrin - Ophtalmologie

    Bordeaux, New Aquitaine, 33076

  • Hôpital Intercommunal - Créteil Cedex

    Créteil, Île-de-France Region, 94010

  • CHU Dijon - Hopital Francois Miterrand

    Dijon, Bourgogne-Franche-Comté, 21000

  • Hôpital de la Croix Rousse

    Lyon, Auvergne-Rhône-Alpes, 69004

  • Centre d'Ophtalmologie - Paradis-Monticelli

    Marseille, Provence-Alpes-Côte d'Azur Region, 13008

  • Clinique Jules Verne - Nantes

    Nantes, Pays de la Loire Region, 44000

  • Centre d'ophtalmologie de l'Odéon

    Paris, Île-de-France Region, 75006

  • Centre Ophthalmologie d'Imagerie et de Laser

    Paris, Île-de-France Region, 75015

  • AP-HP - Hopital Lariboisiere

    Paris, Île-de-France Region, 75475

  • Centre Hospitalier National d'Ophthalmologie Quinze-Vingt

    Paris, Île-de-France Region, 75557

  • CM Wolff

    Strasbourg, Grand Est, 67000

  • Centre Ophtalmologique Transparence - Tours

    Tours, Centre-Val de Loire, 37000

Other trials in France

Israel11 sites

  • Clalit Health | Soroka Medical Center- Nephrology Department

    Beersheba, 8410101

  • Rambam Health Corporation

    Haifa, 3109601

  • Lady Davis Carmel Medical Center

    Haifa, 3436212

  • Edith Wolfson Medical Center | Internal Medicine Department

    Holon, 5822012

  • Hadassah Hebrew University Hospital Ein Kerem

    Jerusalem, 9112001

  • Meir Medical Center

    Kfar Saba, 4428164

  • Rabin Medical Center | Beilinson Hospital - Nephrology and Hypertension Institute

    Petah Tikva, 4941492

  • Kaplan Medical Center

    Rehovot, 7610001

  • Tel- Aviv Sourasky Medical Center - Nephrology

    Tel Aviv, 6423906

  • Assuta Medical Centers - HaShalom

    Tel Aviv, 6789140

  • Shamir Medical Center (Assaf Harofeh)

    Ẕerifin, 7030000

Other trials in Israel

South Korea11 sites

  • Pusan National University Hospital

    Busan, Busan, 49241

  • Yeungnam University Medical Center

    Daegu, Daegu, 42415

  • Ansan Hospital | Nephrology

    Gyeonggi-do, 425-707

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul Teugbyeolsi, 03722

  • Asan Medical Center | Ophthalmology

    Seoul, Seoul Teugbyeolsi, 05505

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, Seoul Teugbyeolsi, 06273

  • Samsung Medical Center - Oncology Department

    Seoul, 06351

  • St. Mary Hospital

    Seoul, 06591

  • Kim's Eye Hospital

    Seoul, 07301

Other trials in South Korea

Australia10 sites

  • Adelaide Eye and Retina Centre

    Adelaide, South Australia, 5000

  • Eyeclinic Albury Wodonga

    Albury, New South Wales, 2640

  • Centre for Eye Research

    East Melbourne, Victoria, 3002

  • Hobart Eye Surgeons

    Hobart, Tasmania, 7000

  • Lion Eye Institute

    Nedlands, Western Australia, 6009

  • Marsden Eye Surgery Center

    Parramatta, New South Wales, 2150

  • Strathfield Retina Clinic

    Strathfield, New South Wales, 2135

  • Sydney Eye Hospital

    Sydney, New South Wales, 2000

  • Sydney Retina Clinic

    Sydney, New South Wales, 2000

  • Sydney West Retina Pty Ltd

    Westmead, New South Wales, 2145

Other trials in Australia

Spain10 sites

  • Hospital Clinic De Barcelona | Oftamologia

    Barcelona, Barcelona, 08028

  • Hospital Universitari Vall D Hebron | Oftalmologia

    Barcelona, Barcelona, 08035

  • Hospital De La Santa Creu I Sant Pau | Oftalmologia

    Barcelona, Barcelona, 8025

  • Hospital Universitario Puerta De Hierro De Majadahonda | Oftalmologia

    Majadahonda, Madrid, 28222

  • Clinica Universidad De Navarra | Pamplona | Oftalmologia

    Pamplona, Pamplona, 31008

  • Hospital Universitari General De Catalunya | Oftalmologia

    Sant Cugat del Vallès, Barcelona, 08195

  • Instituto Oftalmologico Gomez-Ulla S.L. | Oftalmologia

    Santiago de Compostela, A Coruña, 15706

  • Hospital General Universitario De Valencia | Oftalmologia

    Valencia, 46014

  • Hospital Universitario Rio Hortega | Oftalmologia

    Valladolid, Valladolid, 47012

  • Hospital Universitario Miguel Servet | Oftalmologia

    Zaragoza, Zaragoza, 50009

Other trials in Spain

United Kingdom10 sites

  • Bradford Royal Infirmary

    Bradford, West Yorkshire, BD9 6RJ

  • Frimley Park Hospital NHS

    Frimley, Surrey, GU167UJ

  • Hull and East Yorkshire Eye Hospital Hull and East Yorkshire

    Hull, East Riding of Yorkshire, HU32JZ

  • Leeds Teaching Hospitals NHS Trust | St James's University Hospital - Oncology

    Leeds, West Yorkshire, LS9 7TF

  • Leicester Royal Infirmary

    Leicester, Leicestershire, LE1 5WW

  • Royal Liverpool University Hospital

    Liverpool, Merseyside, L7 8XP

  • Moorfields Eye Hospital

    London, Greater London, EC1V2PD

  • Sunderland Eye Infirmary

    Sunderland, Tyne and Wear, SR29HP

  • New Cross Hospital

    Wolverhampton, West Midlands, WV100QP

  • York Teaching Hospital

    York, North Yorkshire, YO611DW

Other trials in United Kingdom

Poland9 sites

  • Prywatna Klinika Okulistyczna OFTALMIKA

    Bydgoszcz, 85-631

  • Specjalistyczny Osrodek Okulistyczny Oculomedica

    Bydgoszcz, 85-870

  • Profesorskie Centrum Okulistyki

    Gdansk, 80-809

  • Gabinet Okulistyczny Prof. Edward Wylegala

    Katowice, 40-594

  • Centrum Medyczne Dietla 19 Sp. z o.o.

    Krakow, 31-070

  • Centrum Medyczne PROMED

    Krakow, 31-411

  • Centrum Diagnostyki i Mikrochirurgii Oka Lens

    Olsztyn, 10-424

  • Osrodek Chirurgii Oka prof. Zagorskiego Sp. z o.o.

    Rzeszów, 35-017

  • Centrum Medyczne Piasta 47

    Wałbrzych, 58-304

Other trials in Poland

Czechia7 sites

  • Fakultní Nemocnice Hradec Kralové

    Hradec Králové, 500 05

  • Fakultní nemocnice Ostrava

    Ostrava, 708 52

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

    Pardubice, 530 03

  • Fakultní nemocnice Královské Vinohrady - Urologická klinikay

    Prague, 10034

  • Všeobecná fakultní nemocnice v Praze

    Prague, 12808

  • Lexum a.s., Evropska ocni klinika

    Prague, 140 00

  • Axon Clinical, s.r.o.

    Prague, 150 00

Other trials in Czechia

Hungary7 sites

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest, 1062

  • University of Semmelweis/ Semmelweis Egyetem

    Budapest, 1083

  • Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet

    Budapest, 1106

  • Budapest Retina Associates

    Budapest, 1133

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Ganglion Medical Center

    Pécs, 7621

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

    Szeged, 6720

Other trials in Hungary

Italy7 sites

  • ASST Fatebenefratelli Sacco

    Milan, Lombardy, 20122

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122

  • Ospedale San Raffaele s.r.l.

    Milan, Lombardy, 20132

  • Azienda Ospedaliera Policlinico Universitario Tor Vergata - Patologie Retiniche

    Rome, Lazio, 00133

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oculistica

    Rome, Lazio, 00136

  • Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia - UOS Retina Medica

    Rome, Lazio, 00184

  • Azienda Ospedaliero Universitaria Delle Marche - Clinica Oculistica

    Torrette, Ancona, 60126

Other trials in Italy

Turkey (Türkiye)7 sites

  • Ankara Etlik City Hospital | Ophthalmology

    Ankara, 06170

  • Hacettepe Universitesi Tip Fakultesi

    Ankara, 06230

  • SBU Gulhane Egitim ve Arastirma Hastanesi

    Ankara, 6010

  • Ankara Numune Egitim ve Arastirma Hastanesi

    Ankara, 6100

  • Adnan Menderes Universitesi Tip fakultesi

    Aydin, 9100

  • Ankara Bilkent Sehir Hastanesi

    Bilkent Ankara, 6800

  • Kocaeli Universitesi Tip Fakultesi

    Kocaeli, 41380

Other trials in Turkey (Türkiye)

Portugal6 sites

  • AIBILI

    Coimbra, Coimbra District, 3000-548

  • Espaco Medico de Coimbra

    Coimbra, Coimbra District, 3000-548

  • CHLC - Hospital dos Capuchos - Servico de Oftalmologia

    Lisbon, Lisbon District, 1169-050

  • Centro Hospitalar Universitario do Porto

    Porto, Porto District, 4099-001

  • Unidade Local de Saúde de São João E.P.E. - Hospital São João - Serviço de Oftalmologia

    Porto, Porto District, 4200-319

  • Centro Hospitalar Vila Nova de Gaia e Espinho | Unit 1 - Clinical Research Center

    Porto, Porto District, 4434-502

Other trials in Portugal

Slovakia6 sites

  • Fakultna Nemocnica s poliklinikou F.D.Roosevelta

    Banská Bystrica, Banská Bystrica Region, 975 17

  • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

    Bratislava, Bratislava Region, 826 06

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

    Bratislava, Bratislava Region, 851 07

  • Fakultna nemocnica Nitra

    Nitra, Nitra Region, 950 01

  • Fakultna nemocnica Trencin

    Trenčín, Trencín, 911 71

  • Specialized hospital for ophthalmology OPHTAL

    Zvolen, Banská Bystrica Region, 960 01

Other trials in Slovakia

Austria5 sites

  • Medizinische Universität Graz

    Graz, Styria, 8036

  • Klinikum Klagenfurt am Wörthersee

    Linz, Upper Austria, 4010

  • Konventhospital Barmherzige Brüder Linz

    Linz, Upper Austria, 4020

  • Universitätsklinikum AKH Wien

    Vienna, State of Vienna, 1090

  • Hanusch-Krankenhaus Wien

    Vienna, State of Vienna, 1140

Other trials in Austria

Germany5 sites

  • Uniklinik Bonn / Eye Clinic

    Bonn, 53127

  • Uni Heidelberg / Augenklinik

    Heidelberg, 0

  • Klinikum d. Stadt Ludwigshafen - Ophthalmology

    Ludwigshafen, 67063

  • St. Franziskus-Hospital Münster - Eye Center

    Münster, 48145

  • Knappschaftskrankenhaus Sulzbach

    Sulzbach, Saarland, 66280

Other trials in Germany

Switzerland5 sites

  • Berner Augenklinik am Lindenhofspital

    Bern, Canton of Bern, 3007

  • Inselspital Universitätsspital Bern

    Bern, Canton of Bern, 3010

  • Vista Klinik

    Binningen, Basel-Landschaft, 4102

  • University Eye Hospital Jules Gonin

    Lausanne, Canton of Vaud, 1004

  • RétinElysée

    Lausanne, Canton of Vaud, 1006

Other trials in Switzerland

Malaysia4 sites

  • Hospital Al-Sultan Abdullah, UiTM | Opthalmology

    Bandar Puncak Alam, Selangor, 42300

  • OasisEye Specialists

    Kuala Lumpur, Kuala Lumpur, 59200

  • Hospital Shah Alam | Ophthalmology

    Shah Alam, Selangor, 40000

  • Hospital Selayang

    Shah Alam, Selangor, 68100

Other trials in Malaysia

Bulgaria3 sites

  • SEHAT Pentagram

    Sofia, Sofia City Province, 1309

  • Specialized Hospital For Active Treatment of Eye Diseases Zora

    Sofia, Sofia City Province, 1784

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

    Varna, Varna Province, 9000

Other trials in Bulgaria

Estonia3 sites

  • AS Ida-Tallinna Keskhaigla - Oftalmoloogiakeskus

    Tallinn, Harju, 10138

  • Dr. Kai Noor Silmakabinet OÜ

    Tallinn, Harju, 11412

  • Sihtasutus Tartu Ülikooli Kliinikum - Silmakliinik

    Tartu, Tartu County, 50406

Other trials in Estonia

Serbia3 sites

  • Clinical Center of Serbia

    Belgrade, 11000

  • Clinical hospital center Zvezdara

    Belgrade, 11000

  • Klinicki centar Vojvodine

    Novi Sad, 21000

Other trials in Serbia

Georgia2 sites

  • LTD "Chichua Medical Center MZERA"

    Tbilisi, K'alak'i T'bilisi, 114

  • LTD "IQ Clinic"- Ophthalmology

    Tbilisi, K'alak'i T'bilisi, 162

Other trials in Georgia

Latvia2 sites

  • Department of Ophthalmology

    Riga, Riga City, LV-1002

  • Riga East Clinical University Hospital "Gailezers"

    Riga, Riga City, LV-1038

Other trials in Latvia

Lithuania2 sites

  • Hospital of LT University of Health Sciences Kaunas Clinics

    Kaunas, LT-50161

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, LT-08661

Other trials in Lithuania

Thailand2 sites

  • Chiangmai University

    Chiang Mai, 50200

  • Srinagarind Hospital

    Khon Kaen, 40002

Other trials in Thailand

About this study

Official title: 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.

Read more

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.

Being tested
Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose, Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_2 mg, Sham, Fluorescein

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Intravitreally (IVT) injection.

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

    Intravitreally (IVT) injection.

  • ShamDrug

    Sham procedure will be given on visits when an active injection is not planned.

  • FluoresceinDiagnostic test

    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.

Study groups in NCT05850520
Study groupRoleWhat they receive
Higher Dose Regimen 1ExperimentalHigher 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.
Receives: Drug: Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose; Drug: Sham; Diagnostic Test: Fluorescein
Higher Dose Regimen 2ExperimentalHigher 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.
Receives: Drug: Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose; Drug: Sham; Diagnostic Test: Fluorescein
Standard of careActive comparatorAflibercept 2 mg is administered by standard treatment intervals, followed by adjustment of treatment intervals according to treatment response.
Receives: Drug: Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_2 mg; Diagnostic Test: Fluorescein

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: At Week 36

Secondary outcomes (16)

  1. Number of Active Injections From Baseline to Week 64

    Active injections refer to the number of injections that were actually administered, as opposed to the number of planned injections.

    Measured: From baseline to Week 64

  2. 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.

    Measured: From baseline to Week 36

  3. Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 44*

    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).

    *This endpoint was only measured for the 8q8/5 and 2q4 groups

    Measured: At Week 44

  4. Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 64

    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)

    Measured: At Week 64

  5. Participants Gaining at Least 15 Letters in BCVA From Baseline at Weeks 36 and 64

    Measured: From baseline at Weeks 36 and 64

  6. Participants 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)

    Measured: At Weeks 36 and 64

  7. Participants Having no Intraretinal Fluid (IRF) and no Sub-retinal Fluid (SRF) in the Center Subfield at Weeks 36 and 64

    Number of participants with no retinal fluid (no IRF and no SRF) in the central subfield at Weeks 36 and 64

    Measured: At Weeks 36 and 64

  8. Change From Baseline in Central Sub-field Thickness (CST) at Week 36

    Measured: From baseline to Week 36

  9. Change From Baseline in Central Sub-field Thickness (CST) at Week 64

    Measured: From baseline to Week 64

  10. 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).

    Measured: From baseline to Week 36

  11. Change From Baseline in NEI VFQ 25 Total Score at Week 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).

    Measured: From baseline at Week 64

  12. 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.

    Measured: Through Week 36

  13. Participant Having Last Treatment Interval ≥12 or of 16 Weeks at Week 64

    The proportion of participants having last completed treatment interval ≥12 or of 16 weeks at Week 64 for Week 64 completers.

    Measured: At Week 64

  14. Participant Having Next Intended Interval ≥12, ≥16 or of 20 Weeks at Week 64

    The proportion of participants having last intended treatment interval ≥12, ≥16 or 20 weeks at Week 64 for Week 64 completers.

    Measured: At Week 64

  15. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Through Weeks 36 and 64

    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)

    Measured: Through Weeks 36 and 64

  16. Systemic Exposure to Aflibercept as Assessed by Plasma Concentrations of Free, Adjusted Bound and Total Aflibercept From Baseline Through Weeks 36 and 64

    Total aflibercept is the sum of free and adjusted bound aflibercept.

    Measured: From baseline through Week 36 and 64

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2023
  2. Study start15 May 2023
  3. Primary completion7 Nov 2024
  4. Study completion27 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
892 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05850520
Sponsor's protocol ID
22153
Other IDs
2022-502174-16-00
Acronym
QUASAR
Status last verified
Jun 2026
First submitted
28 Apr 2023
Last updated
17 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose, Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_2 mg and Fluorescein in people with Macular Edema Secondary to Retinal Vein Occlusion, run by Bayer at 273 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 273 sites in United States, Japan, China, France, Israel and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 36 (time frame: At Week 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05850520.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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