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
2 other identifiers
interventional
892
25 countries
260
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2023
260 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2023
CompletedFirst Posted
Study publicly available on registry
May 9, 2023
CompletedStudy Start
First participant enrolled
May 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 27, 2025
CompletedResults Posted
Study results publicly available
December 18, 2025
CompletedDecember 18, 2025
December 1, 2025
1.5 years
April 28, 2023
November 3, 2025
December 3, 2025
Conditions
Outcome Measures
Primary Outcomes (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)
At Week 36
Secondary Outcomes (9)
Number of Active Injections From Baseline to Week 36
From baseline to Week 36
Participants Gaining at Least 15 Letters in BCVA From Baseline at Week 36
From baseline at Week 36
Participants Achieving an ETDRS Letter Score of at Least 69 (Approximate 20/40 Snellen Equivalent) at Week 36
At Week 36
Participants Having no Intraretinal Fluid (IRF) and no Sub-retinal Fluid (SRF) in the Center Subfield at Week 36
At Week 36
Change From Baseline in Central Sub-field Thickness (CST) at Week 36
From baseline to Week 36
- +4 more secondary outcomes
Study Arms (3)
Higher Dose Regimen 1
EXPERIMENTALHigher 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.
Higher Dose Regimen 2
EXPERIMENTALHigher 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.
Standard of care
ACTIVE COMPARATORAflibercept 2 mg is administered by standard treatment intervals, followed by adjustment of treatment intervals according to treatment response.
Interventions
Intravitreally (IVT) injection.
Intravitreally (IVT) injection.
Sham procedure will be given on visits when an active injection is not planned.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Regeneron Pharmaceuticalscollaborator
Study Sites (273)
Retina Consultants of Orange County - Fullerton
Fullerton, California, 92835, United States
South Coast Retina - Long Beach
Long Beach, California, 90807, United States
Northern California Retina Vitreous Associates - Mountain View Office
Mountain View, California, 94040, United States
Desert Retina Consultants - Palm Springs Office
Palm Springs, California, 92262, United States
Azul Vision Pasadena
Pasadena, California, 91107, United States
Retina Consultants of Southern California
Redlands, California, 92374, United States
Retina Consultants of Southern Colorado, PC
Colorado Springs, Colorado, 80909, United States
New England Retina Associates
New London, Connecticut, 06320, United States
Rand Eye Institute
Deerfield Beach, Florida, 33064, United States
National Ophthalmic Research Institute - Fort Myers
Fort Myers, Florida, 33912, United States
The Eye Institute of West Florida - Largo
Largo, Florida, 33770, United States
Florida Eye Associates - Melbourne Main Office
Melbourne, Florida, 32901, United States
Florida Retina Institute - Orlando
Orlando, Florida, 32806, United States
Retina Specialty Institute - Pensacola
Pensacola, Florida, 32503, United States
Fort Lauderdale Eye Institute
Plantation, Florida, 33324, United States
Retina Vitreous Associates of Florida - Saint Petersburg
St. Petersburg, Florida, 33711, United States
East Florida Eye Institute
Stuart, Florida, 34994, United States
Center for Retina and Macular Disease - Winter Haven
Winter Haven, Florida, 33880, United States
Marietta Eye Clinic
Marietta, Georgia, 30060, United States
Retina Associates - Elmhurst
Elmhurst, Illinois, 60126, United States
University Retina and Macula Associates - Oak Forest
Oak Forest, Illinois, 60452, United States
Retina Associates - Lenexa
Lenexa, Kansas, 66215, United States
The Retina Care Center - Baltimore
Baltimore, Maryland, 21209, United States
Cumberland Valley Retina Consultants | Hagerstown, MD
Hagerstown, Maryland, 21740, United States
Mid Atlantic Retina Specialists - Hagerstown
Hagerstown, Maryland, 21740, United States
Vitreo-Retinal Associates - Worcester
Grand Rapids, Michigan, 49525, United States
RCM - St. Louis Park Retina Clinic
Saint Louis Park, Minnesota, 55416, United States
Retina Consultants of Nevada - Summerlin
Las Vegas, Nevada, 89144, United States
Retina Center of New Jersey
Bloomfield, New Jersey, 07003, United States
NJ Retina - New Brunswick
New Brunswick, New Jersey, 08901, United States
NJ Retina | Teaneck
Teaneck, New Jersey, 07666, United States
Vision Research Center
Albuquerque, New Mexico, 87109, United States
Vitreoretinal Consultants of NY - Great Neck
Great Neck, New York, 11021, United States
Vitreoretinal Consultants of NY - Hauppauge
Hauppauge, New York, 11788, United States
Ophthalmic Consultants of Long Island
Lynbrook, New York, 11563, United States
Retina Associates of Western New York
Rochester, New York, 14620, United States
Cincinnati Eye Institute - Blue Ash
Blue Ash, Ohio, 45242-5664, United States
Midwest Retina - Main Office
Dublin, Ohio, 43016, United States
Retina Consultants, LLC
Salem, Oregon, 97302, United States
Mid Atlantic Retina - Bethlehem
Bethlehem, Pennsylvania, 18107, United States
Mid Atlantic Retina - Philadelphia / Wills Eye Hospital
Philadelphia, Pennsylvania, 19107, United States
Palmetto Retina Center, LLC - Florence
Florence, South Carolina, 29501, United States
Retina Consultants of South Carolina - Ladson
Ladson, South Carolina, 29456, United States
Charles Retina Specialists - Germantown
Memphis, Tennessee, 38119, United States
Austin Retina Associates - Central
Austin, Texas, 78705, United States
Retina Consultants of Texas - Bellaire
Bellaire, Texas, 77401, United States
Texas Retina Associates - Fort Worth
Fort Worth, Texas, 76104, United States
Medical Center Ophthalmology Associates - Northwest
San Antonio, Texas, 78240, United States
Retina Consultants of Texas - San Antonio Medical Center
San Antonio, Texas, 78240, United States
Rocky Mountain Retina Consultants - Main Office
Salt Lake City, Utah, 84107, United States
The Retina Group of Washington - Fairfax
Fairfax, Virginia, 22031, United States
Spokane Eye Clinical Research - South Hill / Downtown
Spokane, Washington, 99204, United States
UW Health Carbone Cancer Center
Madison, Wisconsin, 53792, United States
Eyeclinic Albury Wodonga
Albury, New South Wales, 2640, Australia
Marsden Eye Surgery Center
Parramatta, New South Wales, 2150, Australia
Strathfield Retina Clinic
Strathfield, New South Wales, 2135, Australia
Sydney Eye Hospital
Sydney, New South Wales, 2000, Australia
Sydney Retina Clinic
Sydney, New South Wales, 2000, Australia
Sydney West Retina Pty Ltd
Westmead, New South Wales, 2145, Australia
Adelaide Eye and Retina Centre
Adelaide, South Australia, 5000, Australia
Hobart Eye Surgeons
Hobart, Tasmania, 7000, Australia
Centre for Eye Research
East Melbourne, Victoria, 3002, Australia
Lion Eye Institute
Nedlands, Western Australia, 6009, Australia
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Carinthia, 9020, Austria
Medizinische Universität Graz
Graz, Styria, 8036, Austria
Konventhospital Barmherzige Brüder Linz
Linz, Upper Austria, 4021, Austria
Universitätsklinikum AKH Wien
Vienna, 1090, Austria
Hanusch-Krankenhaus Wien
Vienna, 1140, Austria
SEHAT Pentagram
Sofia, 1309, Bulgaria
Specialized Hospital For Active Treatment of Eye Diseases Zora
Sofia, 1784, Bulgaria
Spec. Hosp. of Ophthalm. Disease for Active Treatment Varna
Varna, 9000, Bulgaria
The Second Hospital of Anhui medical university
Hefei, Anhui, 230601, China
Peking University First Hospital - Oncology Department
Beijing, Beijing Municipality, 100034, China
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
Guangzhou Aier Eye Hospital
Guangzhou, Guangdong, 634050, China
Hebei eye hospital
Hebei, Hebei, 050010, China
Shijiazhuang General Hospital
Shijiazhuang, Hebei, 50000, China
Henan Provincial Eye Hospital
Henan, Henan, 450008, China
Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
Wuhan, Hubei, 430030, China
Eye Center of the second Bethune Hospital, jinlin University
Changchun, Jilin, 130022, China
The Fourth People's Hospital of Shenyang
Shenyang, Liaoning, 110082, China
Aier Eye Hospital (LIAONING)
Shenyang, Liaoning, China
People's Hospital of Ningxia Hui Autonomous Region - Opthalmology
Ningxia, Ningxia, 750002, China
Shanxi Eye Hospital
Shanxi, Shaanxi, 030002, China
Qilu Hosp., Shandong Univ.
Jinan, Shandong, 250000, China
Aier Eye Hospital (Chengdu)
Chengdu, Sichuan, China
ZheJiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
Dongyang People's Hospital
Jinhua, Zhejiang, 322199, China
Beijing Aier Intech Eye Hospital
Beijing, 100000, China
China-Japan Friendship Hospital
Beijing, 100029, China
Capital Medical University (CMU) - Beijing Tongren Hospital
Beijing, 100062, China
Peking Union Medical College Hospital CAMS
Beijing, 100730, China
Chongqing Aier Ophthalmology Hospital
Chongqing, 400020, China
Lanzhou University - The Second Hospital (The Second Clinical Medical College of Lanzhou University)
Lanzhou, 730030, China
Tianjin Medical University Eye Hospital
Tianjin, 300384, China
Fakultní Nemocnice Hradec Kralové
Hradec Králové, 500 05, Czechia
Fakultní nemocnice Ostrava
Ostrava, 708 52, Czechia
Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice
Pardubice, 530 03, Czechia
Fakultní nemocnice Královské Vinohrady - Urologická klinikay
Prague, 10034, Czechia
Všeobecná fakultní nemocnice v Praze
Prague, 12808, Czechia
Lexum a.s., Evropska ocni klinika
Prague, 140 00, Czechia
Axon Clinical, s.r.o.
Prague, 150 00, Czechia
AS Ida-Tallinna Keskhaigla - Oftalmoloogiakeskus
Tallinn, 10138, Estonia
Dr. Kai Noor Silmakabinet OÜ
Tallinn, 11412, Estonia
Sihtasutus Tartu Ülikooli Kliinikum - Silmakliinik
Tartu, 50406, Estonia
Centre Hospitalier National d'Ophthalmologie Quinze-Vingt
Paris, Cedex 12, 75557, France
Clinique Rétine Tourny
Bordeaux, 33000, France
CHU Bordeaux - Hopital Pellegrin - Ophtalmologie
Bordeaux, 33076, France
Hôpital Intercommunal - Créteil Cedex
Créteil, 94010, France
CHU Dijon - Hopital Francois Miterrand
Dijon, 21000, France
Hôpital de la Croix Rousse
Lyon, 69004, France
Centre d'Ophtalmologie - Paradis-Monticelli
Marseille, 13008, France
Clinique Jules Verne - Nantes
Nantes, 44000, France
Centre d'ophtalmologie de l'Odéon
Paris, 75006, France
Centre Ophthalmologie d'Imagerie et de Laser
Paris, 75015, France
AP-HP - Hopital Lariboisiere
Paris, 75475, France
CM Wolff
Strasbourg, 67000, France
Centre Ophtalmologique Transparence - Tours
Tours, 37000, France
LTD "IQ Clinic"- Ophthalmology
Tbilisi, 0162, Georgia
LTD "Chichua Medical Center MZERA"
Tbilisi, 114, Georgia
Knappschaftskrankenhaus Sulzbach
Sulzbach, Saarland, 66280, Germany
Uniklinik Bonn / Eye Clinic
Bonn, 53127, Germany
Uni Heidelberg / Augenklinik
Heidelberg, 0, Germany
Klinikum d. Stadt Ludwigshafen - Ophthalmology
Ludwigshafen, 67063, Germany
St. Franziskus-Hospital Münster - Eye Center
Münster, 48145, Germany
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, 1062, Hungary
University of Semmelweis/ Semmelweis Egyetem
Budapest, 1083, Hungary
Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
Budapest, 1106, Hungary
Budapest Retina Associates
Budapest, 1133, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Ganglion Medical Center
Pécs, 7621, Hungary
SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
Szeged, 6720, Hungary
Clalit Health | Soroka Medical Center - Internal Medicine Department
Beersheba, 8410101, Israel
Rambam Health Corporation
Haifa, 3109601, Israel
Lady Davis Carmel Medical Center
Haifa, 3436212, Israel
Edith Wolfson Medical Center | Internal Medicine Department
Holon, 5822012, Israel
Hadassah Hebrew University Hospital Ein Kerem
Jerusalem, 9112001, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Rabin Medical Center | Beilinson Hospital - Internal Medicine C Department
Petah Tikva, 4941492, Israel
Kaplan Medical Center
Rehovot, 7610001, Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Assuta Medical Centers - HaShalom
Tel Aviv, 6789140, Israel
Shamir Medical Center (Assaf Harofeh)
Ẕerifin, 7030000, Israel
Azienda Ospedaliero Universitaria Delle Marche - Clinica Oculistica
Torrette, Ancona, 60126, Italy
Azienda Ospedaliera Policlinico Universitario Tor Vergata - Patologie Retiniche
Rome, Lazio, 00133, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oculistica
Rome, Lazio, 00136, Italy
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia - UOS Retina Medica
Rome, Lazio, 00184, Italy
ASST Fatebenefratelli Sacco
Milan, Lombardy, 20122, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122, Italy
Ospedale San Raffaele s.r.l.
Milan, Lombardy, 20132, Italy
Aichi Medical University Hospital
Nagakute, Aichi-ken, 480-1195, Japan
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602, Japan
International University of Health and Welfare Narita Hospital
Narita, Chiba, 286-8520, Japan
Toho University Sakura Medical Center
Sakura, Chiba, 285-8741, Japan
University of Fukui Hospital
Yoshida, Fukui, 910-1193, Japan
Kurume University Hospital
Kurume, Fukuoka, 830-0011, Japan
Southern Tohoku Eye Clinic
Kōriyama, Fukushima, 963-8052, Japan
Gunma University Hospital
Maebashi, Gunma, 371-8511, Japan
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki, Hyōgo, 660-8550, Japan
Kobe University Hospital
Kobe, Hyōgo, 650-0017, Japan
Hyogo Medical University Hospital
Nishinomiya, Hyōgo, 663-8501, Japan
Kozawa Eye Hospital and Diabetes Center
Mito, Ibaraki, 310-0845, Japan
Matsumoto Eye Clinic
Toride, Ibaraki, 302-0014, Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken, 761-0793, Japan
Medical corporation Eiwakai Dannoue Ophthalmology clinic
Kawasaki, Kanagawa, 211-0053, Japan
St. Marianna University Hospital
Kawasaki, Kanagawa, 216-8511, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024, Japan
Mie University Hospital
Tsu, Mie-ken, 514-8507, Japan
Shinshu University Hospital
Matsumoto, Nagano, 390-8621, Japan
National Defense Medical College Hospital
Tokorozawa, Saitama, 359-8513, Japan
Shiga University of Medical Science Hospital
Ōtsu, Shiga, 520-2192, Japan
Shida Eye Clinic
Fujieda-shi, Shizuoka, 426-0029, Japan
Nihon University Hospital
Chiyoda-ku, Tkyo, 101-8309, Japan
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, 113-8655, Japan
Chofu Eye Clinic
Chōfu, Tokyo, 182-0024, Japan
Tokyo Medical University Hachioji Medical Center
Hachiōji, Tokyo, 193-0998, Japan
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Itabashi-ku, Tokyo, 173-0015, Japan
Tokiwadai Muranaka Eye Clinic
Itabashi-ku, Tokyo, 174-0071, Japan
National Hospital Organization Tokyo Medical Center
Meguro-ku, Tokyo, 152-8902, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, 162-8666, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, 755-8505, Japan
University of Yamanashi Hospital
Chūō, Yamanashi, 409-3898, Japan
Akita University Hospital
Akita, 010-8543, Japan
Hayashi Eye Hospital
Fukuoka, 812-0011, Japan
Murakami Karindoh Hospital
Fukuoka, 819-8585, Japan
Fukushima Medical University Hospital
Fukushima, 960-1295, Japan
Kagoshima University Hospital
Kagoshima, 890-8520, Japan
University of Miyazaki Hospital
Miyazaki, 889-1692, Japan
Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki, 852-8511, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Osaka Metropolitan University Hospital
Osaka, 545-8586, Japan
Japanese Red Cross Saitama Hospital
Saitama, 330-8553, Japan
Toyama University Hospital
Toyama, 930-0194, Japan
Japanese Red Cross Wakayama Medical Center
Wakayama, 640-8558, Japan
Yamagata University Hospital
Yamagata, 990-9585, Japan
Department of Ophthalmology
Riga, 1002, Latvia
Riga East Clinical University Hospital "Gailezers"
Riga, LV-1038, Latvia
Hospital of LT University of Health Sciences Kaunas Clinics
Kaunas, LT-50161, Lithuania
Vilnius University Hospital Santaros Klinikos
Vilnius, LT-08661, Lithuania
Hospital Al-Sultan Abdullah, UiTM | Opthalmology
Bandar Puncak Alam, Selangor, 42300, Malaysia
Hospital Shah Alam | Ophthalmology
Shah Alam, Selangor, 40000, Malaysia
Hospital Selayang
Shah Alam, Selangor, 68100, Malaysia
OasisEye Specialists
Kuala Lumpur, 59200, Malaysia
Prywatna Klinika Okulistyczna OFTALMIKA
Bydgoszcz, 85-631, Poland
Specjalistyczny Osrodek Okulistyczny Oculomedica
Bydgoszcz, 85-870, Poland
Profesorskie Centrum Okulistyki
Gdansk, 80-809, Poland
Gabinet Okulistyczny Prof. Edward Wylegala
Katowice, 40-594, Poland
Centrum Medyczne Dietla 19 Sp. z o.o.
Krakow, 31-070, Poland
Centrum Medyczne PROMED
Krakow, 31-411, Poland
Centrum Diagnostyki i Mikrochirurgii Oka Lens
Olsztyn, 10-424, Poland
Osrodek Chirurgii Oka prof. Zagorskiego Sp. z o.o.
Rzeszów, 35-017, Poland
Centrum Medyczne Piasta 47
Wałbrzych, 58-304, Poland
AIBILI
Coimbra, 3000-548, Portugal
Espaco Medico de Coimbra
Coimbra, 3000-548, Portugal
CHLC - Hospital dos Capuchos - Servico de Oftalmologia
Lisbon, 1169-050, Portugal
Centro Hospitalar Universitario do Porto
Porto, 4099-001, Portugal
Centro Hospitalar Universitario de Sao Joao | Polo Porto - Centro de Investigacao e Ensaios Clinicos
Porto, 4200-319, Portugal
Centro Hospitalar Vila Nova de Gaia e Espinho | Unit 1 - Clinical Research Center
Porto, 4434-502, Portugal
Clinical Center of Serbia
Belgrade, 11000, Serbia
Clinical hospital center Zvezdara
Belgrade, 11000, Serbia
Klinicki centar Vojvodine
Novi Sad, 21000, Serbia
Fakultna Nemocnica s poliklinikou F.D.Roosevelta
Banská Bystrica, 97517, Slovakia
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
Bratislava, 826 06, Slovakia
Univerzitna nemocnica Bratislava, Nem. Sv. Cyrila a Metoda
Bratislava, 851 07, Slovakia
Fakultna nemocnica Nitra
Nitra, 950 01, Slovakia
Fakultna nemocnica Trencin
Trenčín, 911 71, Slovakia
Specialized hospital for ophthalmology OPHTAL
Zvolen, 96001, Slovakia
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, 13620, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi, 03722, South Korea
University of Ulsan College of Medicine - Asan Medical Center (AMC) - Ophthalmology
Seoul, Seoul Teugbyeolsi, 05505, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 3080, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi, 6273, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Yeungnam University Medical Center
Daegu, 42415, South Korea
Korea University Ansan Hospital
Gyeonggi-do, 425-707, South Korea
Samsung Medical Center - Oncology Department
Seoul, 06351, South Korea
St. Mary Hospital
Seoul, 137-701, South Korea
Kim's Eye Hospital
Seoul, 150-034, South Korea
Instituto Oftalmologico Gomez-Ulla S.L. | Oftalmologia
Santiago de Compostela, A Coruña, 15706, Spain
Hospital Universitari General De Catalunya | Oftalmologia
Sant Cugat del Vallès, Barcelona, 08195, Spain
Hospital Universitario Puerta De Hierro De Majadahonda | Oftalmologia
Majadahonda, Madrid, 28222, Spain
Hospital Clinic De Barcelona | Oftamologia
Barcelona, 08028, Spain
Hospital Universitari Vall D Hebron | Oftalmologia
Barcelona, 08035, Spain
Hospital De La Santa Creu I Sant Pau | Oftalmologia
Barcelona, 8025, Spain
Clinica Universidad De Navarra | Oftalmologia
Pamplona, 31008, Spain
Hospital General Universitario De Valencia | Oftalmologia
Valencia, 46014, Spain
Hospital Universitario Rio Hortega | Oftalmologia
Valladolid, 47012, Spain
Hospital Universitario Miguel Servet | Oftalmologia
Zaragoza, 50009, Spain
RétinElysée
Lausanne, Canton of Vaud, 1006, Switzerland
Inselspital Universitätsspital Bern
Bern, 3010, Switzerland
Berner Augenklinik am Lindenhofspital
Bern, TBC, Switzerland
Vista Klinik
Binningen, 4102, Switzerland
University Eye Hospital Jules Gonin
Lausanne, 1004, Switzerland
Chiangmai University
Chiang Mai, 50200, Thailand
Srinagarind Hospital
Khon Kaen, 40002, Thailand
Ankara Etlik City Hospital | Ophthalmology
Ankara, 06170, Turkey (Türkiye)
SBU Gulhane Egitim ve Arastirma Hastanesi
Ankara, 6010, Turkey (Türkiye)
Ankara Numune Egitim ve Arastirma Hastanesi
Ankara, 6100, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi
Ankara, 6100, Turkey (Türkiye)
Adnan Menderes Universitesi Tip fakultesi
Aydin, 9100, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Bilkent Ankara, 6800, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi
Kocaeli, 41380, Turkey (Türkiye)
Hull and East Yorkshire Eye Hospital Hull and East Yorkshire
Hull, East Riding Of Yorkshire, HU32JZ, United Kingdom
Moorfields Eye Hospital
London, Greater London, EC1V2PD, United Kingdom
Leicester Royal Infirmary
Leicester, Leicestershire, LE1 5WW, United Kingdom
Royal Liverpool University Hospital
Liverpool, Merseyside, L7 8XP, United Kingdom
York Teaching Hospital
York, North Yorkshire, YO611DW, United Kingdom
Frimley Park Hospital NHS
Frimley, Surrey, GU167UJ, United Kingdom
Sunderland Eye Infirmary
Sunderland, Tyne and Wear, SR29HP, United Kingdom
New Cross Hospital
Wolverhampton, West Midlands, WV100QP, United Kingdom
Bradford Royal Infirmary
Bradford, West Yorkshire, BD9 6RJ, United Kingdom
Leeds Teaching Hospitals NHS Trust | St James's University Hospital - Oncology
Leeds, West Yorkshire, LS9 7TF, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2023
First Posted
May 9, 2023
Study Start
May 15, 2023
Primary Completion
November 7, 2024
Study Completion
May 27, 2025
Last Updated
December 18, 2025
Results First Posted
December 18, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share
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.