Back to resultsA 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)
Primary Purpose
Macular Edema Secondary to Retinal Vein Occlusion
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose
Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_2 mg
Sham
Fluorescein
Sponsored by
About this trial
This is an interventional treatment trial for Macular Edema Secondary to Retinal Vein Occlusion
Eligibility Criteria
Inclusion Criteria: Adult ≥18 years of age (or country's legal age of adulthood if the legal age is >18 years) at the time of signing the informed consent. Treatment-naïve macular edema involving the foveal center secondary to RVO (BRVO, HRVO, or CRVO) diagnosed within 16 weeks (112 days) before the screening visit in the study eye. Early Treatment Diabetic Retinopathy Study BCVA letter score of 73 to 24 (20/40 to 20/320) at screening and baseline visits in the study eye. Decrease in BCVA determined to be primarily the result of RVO in the study eye. Mean CST ≥300 μm on optical coherence tomography (OCT) if excluding Bruch's membrane (e.g., Cirrus or Topcon) or ≥320 μm if including Bruch's membrane (e.g., Heidelberg Spectralis), confirmed by the reading center at the screening visit and by the site at baseline visit in the study eye. Capable of giving signed informed consent form (ICF) by study participant or legally acceptable representative, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. US participants will be required to have a Health Insurance Portability and Accountability Act (HIPAA) authorization; in other countries, as applicable according to national laws. Women of childbearing potential (WOCBP) or men who are sexually active with partners of childbearing potential must agree to use highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 4 months after the last administration of study intervention. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for participation in clinical studies and fulfil the conditions set on Section 10.4.2. Exclusion Criteria: Concurrent disease that causes substantial decrease of BCVA, is expected to limit BCVA recovery or is likely to require medical or surgical intervention during the study in the study eye. Presence or history of the following ocular conditions: 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. 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: a. Gene therapy, or cell therapy in the fellow eye at any time. Participation in other clinical studies requiring administration of investigational treatments (other than vitamins and minerals) at the time of screening visit, or within 30 days or 5 half-lives of administration of the previous study intervention, whichever is longer.
Sites / Locations
- Retina Consultants of Orange County
- Mountain View | Ophthalmology
- South Coast Retina Center
- Northern California Retina-Vitreous Associates
- Southern California Desert Retina Consultants
- California Eye Specialists
- Southern California Permanente Medical Group
- Stanford University
- Retina Consultants of Southern Colorado, PC
- New England Retina Associates
- Rand Eye InstituteRecruiting
- National Ophthalmic Research Institute
- Eye Institute of West Florida
- Florida Eye Associates
- Florida Retina Institute
- Retina Specialists
- Fort Lauderdale Eye Institute
- Retina Vitreous Associates of Florida - Saint Petersburg
- East Florida Eye Institute
- University of South Florida
- Center for Retina and Macular Disease
- Marietta Eye Clinic
- Retina Associates IL
- University Retina and Macula Associates
- Retina Associates, LLC
- Retina Care Center
- Cumberland Valley Retina Consultants, PC
- Mid Atlantic Retina Specialists
- Vitreo-Retinal Associates, PC
- Retina Consultants of Minnesota
- Retina Consultants of Nevada
- Sierra Eye Associates
- Retina Center of New Jersey
- NJ Retina
- NJ Retina | Teaneck
- Eye Associates of New Mexico
- Long Island Vitreoretinal Consultants
- Long Island Vitreoretinal Consultants
- Ophthalmic Consultants of Long Island
- Retina Associates of Western New York
- Ophthalmic Consultants of the Capital Region
- University of NC at Chapel Hill (UNC) Ophthalmology
- Wake Forest Baptist Health
- Cincinnati Eye Institute
- Midwest Retina - Main Office
- Retina Consultants, LLC
- Mid Atlantic Retina
- University of Pennsylvania
- Retina Consultants of Charleston
- Palmetto Retina Center, LLC - Florence
- Palmetto Retina Center, LLC
- Charles Retina Institute
- Austin Retina Associates
- Retinal Consultants of Texas - Bellaire
- Texas Retina Associates
- Medical Center Ophthalmology Associates
- Retinal Consultants of Texas - San Antonio
- Rocky Mountain Retina Consultant
- The Retina Group of Washington | Fairfax
- Spokane Eye Clinical Research
- University of Wisconsin - Madison
- Eyeclinic Albury Wodonga
- Marsden Eye Surgery Center
- Strathfield Retina Clinic
- Sydney Eye Hospital
- Sydney Retina Clinic
- Sydney West Retina Pty Ltd
- Adelaide Eye and Retina Centre
- Hobart Eye Surgeons
- Centre for Eye Research
- Lions Eye Institute
- Klinikum Klagenfurt am Wörthersee
- Konventhospital Barmherzige Brüder Linz
- Medizinische Universität Graz
- Kepler Universitätsklinikum Campus III
- Universitätsklinikum AKH Wien
- Hanusch-Krankenhaus Wien
- SEHAT Pentagram
- UMHAT Alexandrovska EAD
- Multiprofile Hospital for Active Treatment Sveta Sofia
- Specialized Hospital For Active Treatment of Eye Diseases Zora
- Spec. Hosp. of Ophthalm. Disease for Active Treatment Varna
- The Second Hospital of Anhui medical university
- Guangzhou Aier Eye Hospital
- Shijiazhuang General Hospital
- Hebei Eye Hospital
- Henan Provincial Ophthalmology Hospital (Henan Eye Institute
- Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
- Renmin Hospital of Wuhan University
- The First People's Hospital of Xuzhou
- Eye Center of the second Bethune Hospital, jinlin University
- Shenyang Fourth People's Hospital - Ophthalmology
- Aier Eye Hospital(SHENYANG)
- The People's Hospital of Ningxia Hui Autonomous Region
- Shanxi Provincial Eye Hospital
- The First Affiliated Hospital of Xi'an Jiaotong University
- Qilu Hospital of Shandong University
- West China Hospital,Sichuan University
- Aier Eye Hospital (Chengdu)
- ZheJiang Provincial People's Hospital
- Dongyang People's Hospital
- The Affiliated Eye Hospital of Wenzhou Medical College
- Beijing Aier Intech Eye Hospital Co. LTD - Ophthalmology
- China-Japan Friendship Hospital
- Beijing Hospital
- Capital Medical University (CMU) - Beijing Tongren Hospital
- Peking Union Medical College Hospital CAMS
- Peking University First Hospital
- Chongqing Aier Ophthalmology Hospital
- The First Affiliated Hospital of Chongqing Medical Universit
- Second Hospital Affiliated of Chongqing Medical University
- Zhejiang University School of Medicine - The First Affiliated Hospital - Kidney Disease Center
- Lanzhou University - The Second Hospital (The Second Clinical Medical College of Lanzhou University)
- Eye & Ent Hospital of Fudan University
- China Medical University (CMU) - First Affiliated Hospital
- Tianjin Medical University General Hospital
- Tianjin Medical University Eye Hospital
- TianJin eye hospital
- Fakultni Nemocnice Hradec Kralove
- Fakultni nemocnice Ostrava
- Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice
- FN Kralovske Vinohrady
- Vseobecna fakultni nemocnice v Praze
- Lexum a.s., Evropska ocni klinika
- AXON Clinical s.r.o.
- East Tallinn Central Hospital
- Turman Eye Clinic
- Dr. Kai Noor Silmakabinet OU
- Tartu University Hospital
- Centre Hospitalier National d'Ophthalmologie Quinze-Vingt
- Clinique Rétine Tourny
- CHU Bordeaux - Hopital Pellegrin - Ophtalmologie
- Hôpital Intercommunal - Créteil Cedex
- Hôpital François Mitterrand - Dijon
- Hôpital de la Croix Rousse
- Centre d'Ophtalmologie - Paradis-Monticelli
- Clinique Jules Verne - Nantes
- Centre d'ophtalmologie de l'Odéon
- Hôpital Lariboisière - Paris
- Centre Ophthalmologie d'Imagerie et de Laser
- CM Wolff
- Centre Ophtalmologique Transparence - Tours
- LTD "IQ Clinic"
- LTD Israeli-Georgian Medical Research Clinic "Helsicore"
- LTD "Chichua Medical Center MZERA"
- Caucasus Medical Center- Opthamology
- Universitätsklinikum Freiburg
- Knappschaftskrankenhaus Sulzbach
- Uniklinik Bonn / Eye Clinic
- Universitätsklinikum Düsseldorf / Ophthalmology
- Universitätsmedizin Göttingen - Ophthalmology
- Medizinische Hochschule Hannover (MHH) - University Clinic for Ophthalmology
- Uni Heidelberg / Augenklinik
- Universitaetsklinikum Jena - Ophthalmology
- Klinikum d. Stadt Ludwigshafen - Ophthalmology
- Universitätsklinik Gießen und Marburg GmbH (UKGM) - Ophthalmology
- St. Franziskus-Hospital Münster - Eye Center
- Ludwig-Maximilians-Universitaet Muenchen (LMU) Klinikum - Eye Clinic and Polyclinic
- Universitaetsklinikum Tuebingen - Ophthalmology
- Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet
- Magyar Honvedseg Egeszsegugyi Kozpont
- University of Semmelweis/ Semmelweis Egyetem
- Bajcsy Zsilinszky Korhaz-Rendelointezet
- Budapest Retina Associates
- Debreceni Egyetem Klinikai Kozpont
- Ganglion Medical Center
- SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
- Soroka University Medical Center
- Rambam Health Corporation
- Lady Davis Carmel Medical Center
- Edith Wolfson Medical Center
- Hadassah Hebrew University Hospital Ein Kerem
- Meir Medical Center
- Clalit Health Services Rabin Medical Center-Beilinson Campus
- Kaplan Medical Center
- Tel-Aviv Sourasky Medical Center
- Assuta Medical Centers - HaShalom
- Shamir Medical Center (Assaf Harofeh)
- Fondazione PTV Policlinico Tor Vergata
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- IRCCS Fondazione G.B. Bietti Studio e Ricerca in Otalmologia
- Ospedale San Raffaele s.r.l.
- ASST Fatebenefratelli Sacco
- A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"
- A.O. Ordine Mauriziano
- A.O.U. Consorziale Policlinico
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
- Nagoya City University Hospital
- International University of Health & Welfare Narita Hospital
- Toho University Sakura Medical Center
- University of Fukui Hospital
- Kurume University Hospital
- Southern Tohoku Eye Clinic
- Gunma University Hospital
- Hyogo Prefectural Amagasaki General Medical Center
- Kobe University Hospital
- Hyogo Medical University Hospital
- Kozawa Eye Hospital and Diabetes Center
- Matsumoto Eye Clinic
- Kagawa University Hospital
- Medical corporation Eiwakai Dannoue Ophthalmology clinic
- Yokohama City University Medical Center
- Mie University Hospital
- Shinshu University Hospital
- National Defense Medical College Hospital
- Shiga University of Medical Science Hospital
- Shida Eye Clinic
- The University of Tokyo Hospital
- Nihon University Hospital
- Chofu Eye Clinic
- Tokyo Medical University Hachioji Medical Center
- Tokyo Metropolitan Institute for Geriatrics and Gerontology
- Tokiwadai Muranaka Eye Clinic
- National Hospital Organization Tokyo Medical Center
- Keio University Hospital
- Tokyo Women's Medical University Hospital
- Yamaguchi University Hospital
- University of Yamanashi Hospital
- Akita University Hospital
- Hayashi Eye Hospital
- Murakami Karindoh Hospital
- Fukushima Medical University Hospital
- Kagoshima University Hospital
- University of Miyazaki Hospital
- Japanese Red Cross Nagasaki Genbaku Hospital
- Osaka Metropolitan University Hospital
- Japanese Red Cross Saitama Hospital
- Japanese Red Cross Wakayama Medical center
- Yamagata University Hospital
- Seoul National University Bundang Hospital
- Gangnam Severance Hospital, Yonsei University Health System
- Pusan National University Hospital
- Yeungnam University Medical Center
- Korea University Ansan Hospital
- Severance Hospital, Yonsei University Health System
- Asan Medical Center
- Seoul National University Hospital
- Samsung Medical Center
- Kim's Eye Hospital
- St. Mary Hospital
- Department of Ophthalmology
- Riga East Clinical University Hospital "Gailezers"
- Latvian American Eye Center
- Hospital of LT University of Health Sciences Kaunas Clinics
- Vilnius University Hospital Santaros Klinikos
- Hospital Al-Sultan Abdullah, UiTM | Opthalmology
- OasisEye Specialists
- Hospital Shah Alam | Ophthalmology
- Hospital Selayang
- Fundacion Hospital Nuestra Señora de la Luz
- Santa Lucia Clinica | Oftalmologica
- FAP Conde de Valenciana, IAP | Oftalmología
- Hospital Angeles Mocel | Oftalmologia
- Instituto Mexicano de Oftalmologia, IMO
- Instituto de la Retina del Bajío SC
- Prywatna Klinika Okulistyczna OFTALMIKA
- Specjalistyczny Osrodek Okulistyczny Oculomedica
- NZOZ Poradnia Okulistyczna Dobry Wzrok
- Profesorskie Centrum Okulistyki
- Gabinet Okulistyczny Prof. Edward Wylegala
- Centrum Medyczne Dietla 19 Sp. z o.o.
- Centrum Medyczne PROMED
- Centrum Diagnostyki i Mikrochirurgii Oka Lens
- Osrodek Chirurgii Oka prof. Zagorskiego Sp. z o.o.
- Centrum Medyczne Piasta 47
- Centro Hospitalar Vila Nova de Gaia/Espinho | Unit 1 - Clinical Research Office
- AIBILI
- Espaco Medico de Coimbra
- CHLC - Hospital dos Capuchos - Servico de Oftalmologia
- Centro Hospitalar Universitario do Porto
- CHUSJ - Hospital Sao Joao
- Clinical Center of Serbia
- Clinical hospital center Zvezdara
- Klinicki centar Vojvodine
- Fakultna Nemocnica s poliklinikou F.D.Roosevelta
- Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
- Univerzitna nemocnica Bratislava, Petrzalka
- Fakultna nemocnica Nitra
- Nemocnica Poprad, a.s.
- Fakultna nemocnica Trencin
- Specialized hospital for ophthalmology OPHTAL
- Instituto Oftalmológico Francisco Gomez Ulla
- Hospital General de Catalunya
- Hospital Universitario Clinica Puerta de Hierro
- Hospital Vall d'Hebron - Servei d'Oftalmologia
- Hospital Clínic i Provincial de Barcelona
- Hospital de la Santa Creu i Sant Pau | Gynecology Department
- Hospital Reina Sofía
- Clínica Universidad de Navarra CUN
- Hospital General Universitario de Valencia
- Hospital del Rio Hortega
- Hospital Miguel Servet
- RétinElysée
- Inselspital Universitätsspital Bern
- Berner Augenklinik am Lindenhofspital
- Vista Klinik
- University Eye Hospital Jules Gonin
- Chiangmai University
- Srinagarind Hospital
- Thammasat University
- Cukurova Universitesi Tip Fakultesi Hastanesi
- SBU Gulhane Egitim ve Arastirma Hastanesi
- Hacettepe Universitesi Tip Fakultesi
- Ankara Etlik City Hospital | Ophthalmology
- Baskent Universitesi Tip Fakultesi Hastanesi
- Gazi Universitesi Tip Fakultesi
- Ankara Numune Egitim ve Arastirma Hastanesi
- Ankara Universitesi Tip Fakultesi Hastanesi
- Ankara Bilkent Sehir Hastanesi
- Adnan Menderes Universitesi Tip fakultesi
- Istanbul Universitesi Istanbul Tip Fakultesi
- Beyoglu Eye Training and Research Hospital
- Ege Universitesi Tip Fakultesi
- Kocaeli Universitesi Tip Fakultesi
- Colchester General Hospital
- Barnet General Hospital
- Leicester Royal Infirmary
- James Paget Hospital
- Epsom General Hospital
- Frimley Park Hospital NHS
- Sunderland Eye Infirmary
- University Hospitals Coventry and Warwickshire NHS Trust
- New Cross Hospital
- St James' University Hospital
- Hull and East Yorkshire Eye Hospital Hull and East Yorkshire
- Bradford Royal Infirmary
- Royal Liverpool University Hospital
- Moorfields Eye Hospital
- York Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Higher Dose Regimen 1
Higher Dose Regimen 2
Standard of care
Arm Description
Higher dose of aflibercept is administered with initial initiation doses intervals, followed by extension of treatment intervals and further adjustment of intervals according to treatment response.
Higher dose of aflibercept is administered with initial initiation doses intervals, followed by extension of treatment intervals and further adjustment of intervals according to treatment response.
Aflibercept 2 mg is administered by standard treatment intervals, followed by adjustment of treatment intervals according to treatment response.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Number of active injections from baseline to Week 64
Number of active injections from baseline to Week 36
Change from baseline in BCVA measured by the ETDRS letter score at Week 44
ETDRS letter score (ranging from 0 to 100 letters). A higher letter score means a better outcome (better visual acuity)
Change from baseline in BCVA measured by the ETDRS letter score at Week 64
ETDRS letter score (ranging from 0 to 100 letters). A higher letter score means a better outcome (better visual acuity)
Number of participants gaining at least 15 letters in BCVA from baseline at Weeks 36 and 64
Number of participant achieving an ETDRS letter score of at least 69 (approximate 20/40 Snellen equivalent) at Weeks 36 and 64
ETDRS letter score (ranging from 0 to 100 letters). A higher letter score means a better outcome (better visual acuity)
Participant having no IRF and no SRF in the center subfield at Weeks 36 and 64 (yes/no)
Change from baseline in CST at Weeks 36 and 64
CST: Central Sub-field Thickness;
Change from baseline in NEI VFQ 25 total score at Weeks 36 and 64
NEI-VFQ-25: National Eye Institute Visual Functioning Questionnaire-25; The NEI VFQ-25 total score ranges from 0 to 100. A higher score means a better outcome (better patient-reported visual function).
Number of participant with TEAEs and SAEs through Weeks 36 and 64
Participants dosed only Q8W through Week 36 in the 8 mg Q8W group
Participants having last treatment intervals ≥12 or of 16 weeks at Week 64
Participants having next intended interval ≥12 or of 16 weeks at Week 64
Systemic exposure to aflibercept as assessed by plasma concentrations of free, adjusted bound and total aflibercept from baseline through Weeks 36 and 64
Full Information
NCT ID
NCT05850520
First Posted
April 28, 2023
Last Updated
September 21, 2023
Sponsor
Bayer
Collaborators
Regeneron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT05850520
Brief Title
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)
Acronym
QUASAR
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
November 29, 2024 (Anticipated)
Study Completion Date
May 16, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
Regeneron Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema Secondary to Retinal Vein Occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
822 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Higher Dose Regimen 1
Arm Type
Experimental
Arm Description
Higher dose of aflibercept is administered with initial initiation doses intervals, followed by extension of treatment intervals and further adjustment of intervals according to treatment response.
Arm Title
Higher Dose Regimen 2
Arm Type
Experimental
Arm Description
Higher dose of aflibercept is administered with initial initiation doses intervals, followed by extension of treatment intervals and further adjustment of intervals according to treatment response.
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Aflibercept 2 mg is administered by standard treatment intervals, followed by adjustment of treatment intervals according to treatment response.
Intervention Type
Drug
Intervention Name(s)
Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose
Intervention Description
Intravitreally (IVT) injection.
Intervention Type
Drug
Intervention Name(s)
Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_2 mg
Intervention Description
Intravitreally (IVT) injection.
Intervention Type
Drug
Intervention Name(s)
Sham
Intervention Description
Sham procedure will be given on visits when an active injection is not planned.
Intervention Type
Diagnostic Test
Intervention Name(s)
Fluorescein
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in BCVA measured by the ETDRS letter score at Week 36
Description
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)
Time Frame
At Week 36
Secondary Outcome Measure Information:
Title
Number of active injections from baseline to Week 64
Time Frame
From baseline to Week 64
Title
Number of active injections from baseline to Week 36
Time Frame
From baseline to Week 36
Title
Change from baseline in BCVA measured by the ETDRS letter score at Week 44
Description
ETDRS letter score (ranging from 0 to 100 letters). A higher letter score means a better outcome (better visual acuity)
Time Frame
At baseline, week 44
Title
Change from baseline in BCVA measured by the ETDRS letter score at Week 64
Description
ETDRS letter score (ranging from 0 to 100 letters). A higher letter score means a better outcome (better visual acuity)
Time Frame
At baseline, week 64
Title
Number of participants gaining at least 15 letters in BCVA from baseline at Weeks 36 and 64
Time Frame
From baseline at week 36 and week 64
Title
Number of participant achieving an ETDRS letter score of at least 69 (approximate 20/40 Snellen equivalent) at Weeks 36 and 64
Description
ETDRS letter score (ranging from 0 to 100 letters). A higher letter score means a better outcome (better visual acuity)
Time Frame
At week 36 and week 64
Title
Participant having no IRF and no SRF in the center subfield at Weeks 36 and 64 (yes/no)
Time Frame
At week 36 and week 64
Title
Change from baseline in CST at Weeks 36 and 64
Description
CST: Central Sub-field Thickness;
Time Frame
At baseline, week 36 and week 64
Title
Change from baseline in NEI VFQ 25 total score at Weeks 36 and 64
Description
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).
Time Frame
At baseline, week 36 and week 64
Title
Number of participant with TEAEs and SAEs through Weeks 36 and 64
Time Frame
Through weeks 36 and 64
Title
Participants dosed only Q8W through Week 36 in the 8 mg Q8W group
Time Frame
Through weeks 36
Title
Participants having last treatment intervals ≥12 or of 16 weeks at Week 64
Time Frame
At week 64
Title
Participants having next intended interval ≥12 or of 16 weeks at Week 64
Time Frame
At week 64
Title
Systemic exposure to aflibercept as assessed by plasma concentrations of free, adjusted bound and total aflibercept from baseline through Weeks 36 and 64
Time Frame
From baseline through weeks 36 and 64
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult ≥18 years of age (or country's legal age of adulthood if the legal age is >18 years) at the time of signing the informed consent.
Treatment-naïve macular edema involving the foveal center secondary to RVO (BRVO, HRVO, or CRVO) diagnosed within 16 weeks (112 days) before the screening visit in the study eye.
Early Treatment Diabetic Retinopathy Study BCVA letter score of 73 to 24 (20/40 to 20/320) at screening and baseline visits in the study eye.
Decrease in BCVA determined to be primarily the result of RVO in the study eye.
Mean CST ≥300 μm on optical coherence tomography (OCT) if excluding Bruch's membrane (e.g., Cirrus or Topcon) or ≥320 μm if including Bruch's membrane (e.g., Heidelberg Spectralis), confirmed by the reading center at the screening visit and by the site at baseline visit in the study eye.
Capable of giving signed informed consent form (ICF) by study participant or legally acceptable representative, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
US participants will be required to have a Health Insurance Portability and Accountability Act (HIPAA) authorization; in other countries, as applicable according to national laws.
Women of childbearing potential (WOCBP) or men who are sexually active with partners of childbearing potential must agree to use highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 4 months after the last administration of study intervention. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for participation in clinical studies and fulfil the conditions set on Section 10.4.2.
Exclusion Criteria:
Concurrent disease that causes substantial decrease of BCVA, is expected to limit BCVA recovery or is likely to require medical or surgical intervention during the study in the study eye.
Presence or history of the following ocular conditions:
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.
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:
a. Gene therapy, or cell therapy in the fellow eye at any time.
Participation in other clinical studies requiring administration of investigational treatments (other than vitamins and minerals) at the time of screening visit, or within 30 days or 5 half-lives of administration of the previous study intervention, whichever is longer.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bayer Clinical Trials Contact
Phone
(+)1-888-84 22937
Email
clinical-trials-contact@bayer.com
Facility Information:
Facility Name
Retina Consultants of Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Mountain View | Ophthalmology
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
South Coast Retina Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Northern California Retina-Vitreous Associates
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Southern California Desert Retina Consultants
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
California Eye Specialists
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Southern California Permanente Medical Group
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Retina Consultants of Southern Colorado, PC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
New England Retina Associates
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Rand Eye Institute
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Individual Site Status
Recruiting
Facility Name
National Ophthalmic Research Institute
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Eye Institute of West Florida
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Florida Eye Associates
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Florida Retina Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Retina Specialists
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Fort Lauderdale Eye Institute
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Retina Vitreous Associates of Florida - Saint Petersburg
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711-1141
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
East Florida Eye Institute
City
Stuart
State/Province
Florida
ZIP/Postal Code
34994
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Center for Retina and Macular Disease
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Marietta Eye Clinic
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Retina Associates IL
City
Elmhurst
State/Province
Illinois
ZIP/Postal Code
60126
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University Retina and Macula Associates
City
Oak Forest
State/Province
Illinois
ZIP/Postal Code
60452
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Retina Associates, LLC
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Retina Care Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Cumberland Valley Retina Consultants, PC
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740-5940
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Mid Atlantic Retina Specialists
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Vitreo-Retinal Associates, PC
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Retina Consultants of Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Retina Consultants of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Retina Center of New Jersey
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
NJ Retina
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
NJ Retina | Teaneck
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Eye Associates of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109-5853
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Long Island Vitreoretinal Consultants
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Long Island Vitreoretinal Consultants
City
Hauppauge
State/Province
New York
ZIP/Postal Code
11788
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Ophthalmic Consultants of Long Island
City
Lynbrook
State/Province
New York
ZIP/Postal Code
11563
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Retina Associates of Western New York
City
Rochester
State/Province
New York
ZIP/Postal Code
14620-4655
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Ophthalmic Consultants of the Capital Region
City
Troy
State/Province
New York
ZIP/Postal Code
12180
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of NC at Chapel Hill (UNC) Ophthalmology
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Midwest Retina - Main Office
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Retina Consultants, LLC
City
Salem
State/Province
Oregon
ZIP/Postal Code
97302-2152
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Mid Atlantic Retina
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Retina Consultants of Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Palmetto Retina Center, LLC - Florence
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29501
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Palmetto Retina Center, LLC
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Charles Retina Institute
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Austin Retina Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Retinal Consultants of Texas - Bellaire
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Texas Retina Associates
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Retinal Consultants of Texas - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Rocky Mountain Retina Consultant
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
The Retina Group of Washington | Fairfax
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Spokane Eye Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Wisconsin - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Eyeclinic Albury Wodonga
City
Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Marsden Eye Surgery Center
City
Parramatta
State/Province
New South Wales
ZIP/Postal Code
2150
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Strathfield Retina Clinic
City
Strathfield
State/Province
New South Wales
ZIP/Postal Code
2135
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Sydney Eye Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Sydney Retina Clinic
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Sydney West Retina Pty Ltd
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Adelaide Eye and Retina Centre
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Hobart Eye Surgeons
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Centre for Eye Research
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Lions Eye Institute
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Klinikum Klagenfurt am Wörthersee
City
Klagenfurt
State/Province
Kärnten
ZIP/Postal Code
9020
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Konventhospital Barmherzige Brüder Linz
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4021
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Medizinische Universität Graz
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Kepler Universitätsklinikum Campus III
City
Linz
ZIP/Postal Code
4021
Country
Austria
Individual Site Status
Withdrawn
Facility Name
Universitätsklinikum AKH Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Hanusch-Krankenhaus Wien
City
Wien
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
SEHAT Pentagram
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Name
UMHAT Alexandrovska EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Name
Multiprofile Hospital for Active Treatment Sveta Sofia
City
Sofia
ZIP/Postal Code
1618
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Name
Specialized Hospital For Active Treatment of Eye Diseases Zora
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Name
Spec. Hosp. of Ophthalm. Disease for Active Treatment Varna
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Name
The Second Hospital of Anhui medical university
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230601
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Guangzhou Aier Eye Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
634050
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Shijiazhuang General Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Hebei Eye Hospital
City
Xingtai
State/Province
Hebei
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Henan Provincial Ophthalmology Hospital (Henan Eye Institute
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430040
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The First People's Hospital of Xuzhou
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221002
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Eye Center of the second Bethune Hospital, jinlin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130022
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Shenyang Fourth People's Hospital - Ophthalmology
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110031
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Aier Eye Hospital(SHENYANG)
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The People's Hospital of Ningxia Hui Autonomous Region
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Shanxi Provincial Eye Hospital
City
Taiyuan
State/Province
Shaanxi
ZIP/Postal Code
030072
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Not yet recruiting
Facility Name
West China Hospital,Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Aier Eye Hospital (Chengdu)
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Not yet recruiting
Facility Name
ZheJiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Dongyang People's Hospital
City
Jinhua
State/Province
Zhejiang
ZIP/Postal Code
322199
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The Affiliated Eye Hospital of Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Beijing Aier Intech Eye Hospital Co. LTD - Ophthalmology
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Not yet recruiting
Facility Name
China-Japan Friendship Hospital
City
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Beijing Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Capital Medical University (CMU) - Beijing Tongren Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Peking Union Medical College Hospital CAMS
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Peking University First Hospital
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Chongqing Aier Ophthalmology Hospital
City
Chongqing
ZIP/Postal Code
400020
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The First Affiliated Hospital of Chongqing Medical Universit
City
Chongqing
ZIP/Postal Code
401147
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Second Hospital Affiliated of Chongqing Medical University
City
Chongqing
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Zhejiang University School of Medicine - The First Affiliated Hospital - Kidney Disease Center
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Lanzhou University - The Second Hospital (The Second Clinical Medical College of Lanzhou University)
City
Lanzhou
ZIP/Postal Code
730030
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Eye & Ent Hospital of Fudan University
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Name
China Medical University (CMU) - First Affiliated Hospital
City
Shenyang
ZIP/Postal Code
110001
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Tianjin Medical University Eye Hospital
City
Tianjin
ZIP/Postal Code
300384
Country
China
Individual Site Status
Not yet recruiting
Facility Name
TianJin eye hospital
City
Tianjin
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Fakultni Nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice
City
Pardubice
ZIP/Postal Code
53003
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
FN Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
10034
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
12800
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Lexum a.s., Evropska ocni klinika
City
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
AXON Clinical s.r.o.
City
Praha 5
ZIP/Postal Code
150 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
East Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Individual Site Status
Not yet recruiting
Facility Name
Turman Eye Clinic
City
Tallinn
ZIP/Postal Code
11314
Country
Estonia
Individual Site Status
Not yet recruiting
Facility Name
Dr. Kai Noor Silmakabinet OU
City
Tallinn
ZIP/Postal Code
11412
Country
Estonia
Individual Site Status
Not yet recruiting
Facility Name
Tartu University Hospital
City
Tartu
Country
Estonia
Individual Site Status
Not yet recruiting
Facility Name
Centre Hospitalier National d'Ophthalmologie Quinze-Vingt
City
Paris
State/Province
Cedex 12
ZIP/Postal Code
75557
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Clinique Rétine Tourny
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Not yet recruiting
Facility Name
CHU Bordeaux - Hopital Pellegrin - Ophtalmologie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hôpital Intercommunal - Créteil Cedex
City
Creteil Cedex
ZIP/Postal Code
94010
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hôpital François Mitterrand - Dijon
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hôpital de la Croix Rousse
City
Lyon Cedex 04
ZIP/Postal Code
69317
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Centre d'Ophtalmologie - Paradis-Monticelli
City
Marseille
ZIP/Postal Code
13008
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Clinique Jules Verne - Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Centre d'ophtalmologie de l'Odéon
City
Paris
ZIP/Postal Code
75006
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hôpital Lariboisière - Paris
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Centre Ophthalmologie d'Imagerie et de Laser
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Not yet recruiting
Facility Name
CM Wolff
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Centre Ophtalmologique Transparence - Tours
City
Tours
ZIP/Postal Code
37000
Country
France
Individual Site Status
Not yet recruiting
Facility Name
LTD "IQ Clinic"
City
Tbilisi
ZIP/Postal Code
0162
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Name
LTD Israeli-Georgian Medical Research Clinic "Helsicore"
City
Tbilisi
ZIP/Postal Code
112
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Name
LTD "Chichua Medical Center MZERA"
City
Tbilisi
ZIP/Postal Code
114
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Name
Caucasus Medical Center- Opthamology
City
Tbilisi
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
State/Province
Baden-Württemberg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Knappschaftskrankenhaus Sulzbach
City
Sulzbach
State/Province
Saarland
ZIP/Postal Code
66280
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Uniklinik Bonn / Eye Clinic
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitätsklinikum Düsseldorf / Ophthalmology
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitätsmedizin Göttingen - Ophthalmology
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Medizinische Hochschule Hannover (MHH) - University Clinic for Ophthalmology
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Uni Heidelberg / Augenklinik
City
Heidelberg
ZIP/Postal Code
0
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitaetsklinikum Jena - Ophthalmology
City
Jena
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Klinikum d. Stadt Ludwigshafen - Ophthalmology
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitätsklinik Gießen und Marburg GmbH (UKGM) - Ophthalmology
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
St. Franziskus-Hospital Münster - Eye Center
City
Muenster
ZIP/Postal Code
48145
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Ludwig-Maximilians-Universitaet Muenchen (LMU) Klinikum - Eye Clinic and Polyclinic
City
Munich
ZIP/Postal Code
80336
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitaetsklinikum Tuebingen - Ophthalmology
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet
City
Budapest
ZIP/Postal Code
1024
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
University of Semmelweis/ Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Bajcsy Zsilinszky Korhaz-Rendelointezet
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Budapest Retina Associates
City
Budapest
ZIP/Postal Code
1133
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Ganglion Medical Center
City
Pecs
ZIP/Postal Code
7621
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Soroka University Medical Center
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Rambam Health Corporation
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Lady Davis Carmel Medical Center
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Edith Wolfson Medical Center
City
Holon
ZIP/Postal Code
5822012
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Hadassah Hebrew University Hospital Ein Kerem
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Clalit Health Services Rabin Medical Center-Beilinson Campus
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
7661041
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Assuta Medical Centers - HaShalom
City
Tel Aviv
ZIP/Postal Code
6789140
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Shamir Medical Center (Assaf Harofeh)
City
Zerifin
ZIP/Postal Code
7030000
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Fondazione PTV Policlinico Tor Vergata
City
Roma
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
IRCCS Fondazione G.B. Bietti Studio e Ricerca in Otalmologia
City
Roma
State/Province
Lazio
ZIP/Postal Code
00198
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Ospedale San Raffaele s.r.l.
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
ASST Fatebenefratelli Sacco
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20157
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"
City
Ancona
State/Province
Marche
ZIP/Postal Code
60126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
A.O. Ordine Mauriziano
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10128
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
A.O.U. Consorziale Policlinico
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Nagoya City University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
International University of Health & Welfare Narita Hospital
City
Narita
State/Province
Chiba
ZIP/Postal Code
286-8520
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Toho University Sakura Medical Center
City
Sakura
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
University of Fukui Hospital
City
Yoshida
State/Province
Fukui
ZIP/Postal Code
910-1193
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Kurume University Hospital
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Southern Tohoku Eye Clinic
City
Koriyama
State/Province
Fukushima
ZIP/Postal Code
963-8052
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Gunma University Hospital
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Hyogo Prefectural Amagasaki General Medical Center
City
Amagasaki
State/Province
Hyogo
ZIP/Postal Code
660-8550
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Kobe University Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Hyogo Medical University Hospital
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Kozawa Eye Hospital and Diabetes Center
City
Mito
State/Province
Ibaraki
ZIP/Postal Code
310-0845
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Matsumoto Eye Clinic
City
Toride
State/Province
Ibaraki
ZIP/Postal Code
302-0014
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Kagawa University Hospital
City
Kita-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Medical corporation Eiwakai Dannoue Ophthalmology clinic
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
211-0053
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Yokohama City University Medical Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Mie University Hospital
City
Tsu
State/Province
Mie
ZIP/Postal Code
514-8507
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Shinshu University Hospital
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
390-8621
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
National Defense Medical College Hospital
City
Tokorozawa
State/Province
Saitama
ZIP/Postal Code
359-8513
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Shiga University of Medical Science Hospital
City
Otsu
State/Province
Shiga
ZIP/Postal Code
520-2192
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Shida Eye Clinic
City
Fujieda
State/Province
Shizuoka
ZIP/Postal Code
426-0029
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
The University of Tokyo Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Nihon University Hospital
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
101-8309
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Chofu Eye Clinic
City
Chofu
State/Province
Tokyo
ZIP/Postal Code
182-0024
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Tokyo Medical University Hachioji Medical Center
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
193-0998
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Tokyo Metropolitan Institute for Geriatrics and Gerontology
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-0015
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Tokiwadai Muranaka Eye Clinic
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
174-0071
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
National Hospital Organization Tokyo Medical Center
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Keio University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Tokyo Women's Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Yamaguchi University Hospital
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
755-8505
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
University of Yamanashi Hospital
City
Chuo
State/Province
Yamanashi
ZIP/Postal Code
409-3898
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Akita University Hospital
City
Akita
ZIP/Postal Code
010-8543
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Hayashi Eye Hospital
City
Fukuoka
ZIP/Postal Code
812-0011
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Murakami Karindoh Hospital
City
Fukuoka
ZIP/Postal Code
819-8585
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Kagoshima University Hospital
City
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
University of Miyazaki Hospital
City
Miyazaki
ZIP/Postal Code
889-1692
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Japanese Red Cross Nagasaki Genbaku Hospital
City
Nagasaki
ZIP/Postal Code
852-8511
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Osaka Metropolitan University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Japanese Red Cross Saitama Hospital
City
Saitama
ZIP/Postal Code
330-8553
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Japanese Red Cross Wakayama Medical center
City
Wakayama
ZIP/Postal Code
640-8558
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Yamagata University Hospital
City
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggido
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Gangnam Severance Hospital, Yonsei University Health System
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
6273
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Yeungnam University Medical Center
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Korea University Ansan Hospital
City
Gyeonggi-do
ZIP/Postal Code
425-707
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Kim's Eye Hospital
City
Seoul
ZIP/Postal Code
150-034
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
St. Mary Hospital
City
Seoul
ZIP/Postal Code
6591
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Department of Ophthalmology
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Individual Site Status
Not yet recruiting
Facility Name
Riga East Clinical University Hospital "Gailezers"
City
Riga
ZIP/Postal Code
LV-1006
Country
Latvia
Individual Site Status
Not yet recruiting
Facility Name
Latvian American Eye Center
City
Riga
ZIP/Postal Code
LV-1009
Country
Latvia
Individual Site Status
Not yet recruiting
Facility Name
Hospital of LT University of Health Sciences Kaunas Clinics
City
Kaunas
ZIP/Postal Code
LT-50161
Country
Lithuania
Individual Site Status
Not yet recruiting
Facility Name
Vilnius University Hospital Santaros Klinikos
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Individual Site Status
Not yet recruiting
Facility Name
Hospital Al-Sultan Abdullah, UiTM | Opthalmology
City
Bandar Puncak Alam
ZIP/Postal Code
42300
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Name
OasisEye Specialists
City
Kuala Lumpur
ZIP/Postal Code
59200
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Name
Hospital Shah Alam | Ophthalmology
City
Shah Alam
ZIP/Postal Code
40000
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Name
Hospital Selayang
City
Shah Alam
ZIP/Postal Code
68100
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Name
Fundacion Hospital Nuestra Señora de la Luz
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
6030
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Santa Lucia Clinica | Oftalmologica
City
Guadalajara
ZIP/Postal Code
44670
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
FAP Conde de Valenciana, IAP | Oftalmología
City
Mexico City
ZIP/Postal Code
06800
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Hospital Angeles Mocel | Oftalmologia
City
Mexico City
ZIP/Postal Code
11850
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Instituto Mexicano de Oftalmologia, IMO
City
Queretaro
ZIP/Postal Code
76090
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Instituto de la Retina del Bajío SC
City
Queretaro
ZIP/Postal Code
76187
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Prywatna Klinika Okulistyczna OFTALMIKA
City
Bydgoszcz
ZIP/Postal Code
85-631
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Specjalistyczny Osrodek Okulistyczny Oculomedica
City
Bydgoszcz
ZIP/Postal Code
85-870
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
NZOZ Poradnia Okulistyczna Dobry Wzrok
City
Gdansk
ZIP/Postal Code
80-402
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Profesorskie Centrum Okulistyki
City
Gdansk
ZIP/Postal Code
80-809
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Gabinet Okulistyczny Prof. Edward Wylegala
City
Katowice
ZIP/Postal Code
40-594
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Centrum Medyczne Dietla 19 Sp. z o.o.
City
Krakow
ZIP/Postal Code
31-070
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Centrum Medyczne PROMED
City
Krakow
ZIP/Postal Code
31-411
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Centrum Diagnostyki i Mikrochirurgii Oka Lens
City
Olsztyn
ZIP/Postal Code
10-424
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Osrodek Chirurgii Oka prof. Zagorskiego Sp. z o.o.
City
Rzeszow
ZIP/Postal Code
35-017
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Centrum Medyczne Piasta 47
City
Walbrzych
ZIP/Postal Code
58-304
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Centro Hospitalar Vila Nova de Gaia/Espinho | Unit 1 - Clinical Research Office
City
Vila Nova de Gaia
State/Province
Porto
ZIP/Postal Code
4434-502
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
AIBILI
City
Coimbra
ZIP/Postal Code
3000-548
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Espaco Medico de Coimbra
City
Coimbra
ZIP/Postal Code
3000-548
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
CHLC - Hospital dos Capuchos - Servico de Oftalmologia
City
Lisboa
ZIP/Postal Code
1169-050
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Centro Hospitalar Universitario do Porto
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
CHUSJ - Hospital Sao Joao
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
Clinical hospital center Zvezdara
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
Klinicki centar Vojvodine
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
Fakultna Nemocnica s poliklinikou F.D.Roosevelta
City
Banska Bystrica
ZIP/Postal Code
97517
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Name
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
City
Bratislava
ZIP/Postal Code
82606
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Name
Univerzitna nemocnica Bratislava, Petrzalka
City
Bratislava
ZIP/Postal Code
851 07
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Name
Fakultna nemocnica Nitra
City
Nitra
ZIP/Postal Code
95001
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Name
Nemocnica Poprad, a.s.
City
Poprad
ZIP/Postal Code
058 45
Country
Slovakia
Individual Site Status
Suspended
Facility Name
Fakultna nemocnica Trencin
City
Trencin
ZIP/Postal Code
911 71
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Name
Specialized hospital for ophthalmology OPHTAL
City
Zvolen
ZIP/Postal Code
960 01
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Name
Instituto Oftalmológico Francisco Gomez Ulla
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital General de Catalunya
City
Sant Cugat del Vallés
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Clinica Puerta de Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Vall d'Hebron - Servei d'Oftalmologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Clínic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital de la Santa Creu i Sant Pau | Gynecology Department
City
Barcelona
ZIP/Postal Code
8041
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Reina Sofía
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Clínica Universidad de Navarra CUN
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital del Rio Hortega
City
Valladolid
ZIP/Postal Code
47012
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
RétinElysée
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1006
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
Inselspital Universitätsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
Berner Augenklinik am Lindenhofspital
City
Bern
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
Vista Klinik
City
Binningen
ZIP/Postal Code
4102
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
University Eye Hospital Jules Gonin
City
Lausanne
ZIP/Postal Code
1004
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
Chiangmai University
City
Chiangmai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Not yet recruiting
Facility Name
Srinagarind Hospital
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Not yet recruiting
Facility Name
Thammasat University
City
Pathum Thani,
ZIP/Postal Code
12120
Country
Thailand
Individual Site Status
Not yet recruiting
Facility Name
Cukurova Universitesi Tip Fakultesi Hastanesi
City
Adana
ZIP/Postal Code
1330
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
SBU Gulhane Egitim ve Arastirma Hastanesi
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Hacettepe Universitesi Tip Fakultesi
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Ankara Etlik City Hospital | Ophthalmology
City
Ankara
ZIP/Postal Code
06170
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Baskent Universitesi Tip Fakultesi Hastanesi
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Gazi Universitesi Tip Fakultesi
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Ankara Numune Egitim ve Arastirma Hastanesi
City
Ankara
ZIP/Postal Code
6100
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Ankara Universitesi Tip Fakultesi Hastanesi
City
Ankara
ZIP/Postal Code
6100
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Ankara Bilkent Sehir Hastanesi
City
Ankara
ZIP/Postal Code
6800
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Adnan Menderes Universitesi Tip fakultesi
City
Aydin
ZIP/Postal Code
9100
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Istanbul Universitesi Istanbul Tip Fakultesi
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Beyoglu Eye Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34420
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Ege Universitesi Tip Fakultesi
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Kocaeli Universitesi Tip Fakultesi
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Colchester General Hospital
City
Colchester
State/Province
Essex
ZIP/Postal Code
CO4 5JR
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Barnet General Hospital
City
London Borough Of Barnet
State/Province
Hertfordshire
ZIP/Postal Code
EN53DJ
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
James Paget Hospital
City
Great Yarmouth
State/Province
Norfolk
ZIP/Postal Code
NR316LA
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Epsom General Hospital
City
Epsom
State/Province
Surrey
ZIP/Postal Code
KT18 7EG
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Frimley Park Hospital NHS
City
Frimley
State/Province
Surrey
ZIP/Postal Code
GU167UJ
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Sunderland Eye Infirmary
City
Sunderland
State/Province
Tyne And Wear
ZIP/Postal Code
SR29HP
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
University Hospitals Coventry and Warwickshire NHS Trust
City
Coventry
State/Province
West Midlands
ZIP/Postal Code
CV22DX
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
New Cross Hospital
City
Wolverhampton
State/Province
West Midlands
ZIP/Postal Code
WV100QP
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
St James' University Hospital
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Hull and East Yorkshire Eye Hospital Hull and East Yorkshire
City
Hull
State/Province
York
ZIP/Postal Code
HU32JZ
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Bradford Royal Infirmary
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Royal Liverpool University Hospital
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Moorfields Eye Hospital
City
London
ZIP/Postal Code
EC1V2PD
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
York Teaching Hospital
City
York
ZIP/Postal Code
YO611DW
Country
United Kingdom
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Links:
URL
https://clinicaltrials.bayer.com/
Description
Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
Learn more about this trial
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)
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