check_circleStudy Completed
Macular edema secondary to retinal vein occlusion
Bayer Identifier:
22153
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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)
Trial purpose
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.
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
892Trial Dates
May 2023 - May 2025Phase
Phase 3Could I Receive a placebo
NoProducts
Aflibercept (VEGF Trap-Eye, BAY86-5321)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Hôpital de la Croix Rousse | LYON, 69004, France |
Completed | Centre d'Ophtalmologie - Paradis-Monticelli | MARSEILLE, 13008, France |
Completed | Centre Ophthalmologie d'Imagerie et de Laser | Paris, 75015, France |
Completed | Centre Ophtalmologique Transparence - Tours | Tours, 37000, France |
Completed | AP-HP - Hopital Lariboisiere | PARIS, 75475, France |
Completed | Centre d'ophtalmologie de l'Odéon | PARIS, 75006, France |
Completed | CHU Dijon - Hopital Francois Miterrand | Dijon, 21000, France |
Terminated | Hôpital Intercommunal - Créteil Cedex | CRETEIL CEDEX, 94010, France |
Terminated | Centre Hospitalier National d'Ophthalmologie Quinze-Vingt | Paris, 75557, France |
Completed | CHU Bordeaux - Hopital Pellegrin - Ophtalmologie | Bordeaux, 33076, France |
Completed | CM Wolff | STRASBOURG, 67000, France |
Terminated | Ospedale San Raffaele s.r.l. | Milano, 20132, Italy |
Completed | Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oculistica | Roma, 00136, Italy |
Completed | Azienda Ospedaliera Policlinico Universitario Tor Vergata - Patologie Retiniche | Roma, 00133, Italy |
Completed | Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia | Roma, 198, Italy |
Terminated | ASST Fatebenefratelli Sacco | Milano, 20122, Italy |
Terminated | Hospital Universitario Puerta De Hierro De Majadahonda - Oftalmologia | Majadahonda, 28222, Spain |
Terminated | Hospital de la Santa Creu i de Sant Pau | Barcelona, 8025, Spain |
Completed | Hospital General Universitario de Valencia | Valencia, 46014, Spain |
Terminated | Clínica Universidad de Navarra CUN | Pamplona, 31008, Spain |
Completed | Hospital General de Catalunya - Oftalmologia | Sant Cugat del Valles, 08195, Spain |
Completed | Hospital Universitario Rio Hortega - Oftalmologia | Valladolid, 47012, Spain |
Completed | Hospital Universitario Miguel Servet - Oftalmologia | Zaragoza, 50009, Spain |
Withdrawn | Hospital Reina Sofía | Córdoba, 14004, Spain |
Completed | Axon Clinical, s.r.o. | Praha 5, 150 00, Czech Republic |
Terminated | Fakultní Nemocnice Hradec Kralové | Hradec Kralove, 500 05, Czech Republic |
Completed | Fakultní nemocnice Ostrava | Ostrava, 708 52, Czech Republic |
Completed | Všeobecná fakultní nemocnice v Praze | Praha 2, 12808, Czech Republic |
Completed | Lexum a.s., Evropska ocni klinika | Praha 4, 140 00, Czech Republic |
Withdrawn | Multiprofile Hospital for Active Treatment Sveta Sofia - Opthalmology Department | Sofia, 1618, Bulgaria |
Completed | SEHAT Pentagram | Sofia, 1309, Bulgaria |
Completed | Centro Hospitalar Universitario de Sao Joao | Polo Porto - Centro de Investigacao e Ensaios Clinicos | Porto, 4200-319, Portugal |
Terminated | Centro Hospitalar Universitario do Porto | Porto, 4099-001, Portugal |
Completed | Espaco Medico de Coimbra | Coimbra, 3000-548, Portugal |
Completed | AIBILI | Coimbra, 3000-548, Portugal |
Completed | Universitätsklinikum AKH Wien | Wien, 1090, Austria |
Completed | Klinikum Klagenfurt am Wörthersee | Klagenfurt, 9020, Austria |
Withdrawn | Kepler Universitätsklinikum Campus III | Linz, 4021, Austria |
Completed | Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet | Budapest, 1106, Hungary |
Completed | University of Semmelweis/ Semmelweis Egyetem | Budapest, 1083, Hungary |
Completed | SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont | Szeged, 6720, Hungary |
Completed | Budapest Retina Associates | Budapest, 1133, Hungary |
Completed | Debreceni Egyetem Klinikai Kozpont | Debrecen, 4032, Hungary |
Completed | Ganglion Medical Center | Pecs, 7621, Hungary |
Completed | Fakultna Nemocnica s poliklinikou F.D.Roosevelta | Banska Bystrica, 97517, Slovakia |
Completed | Fakultna nemocnica Nitra | Nitra, 950 01, Slovakia |
Completed | Fakultna nemocnica Trencin | Trencin, 911 71, Slovakia |
Completed | Univerzitna nemocnica Bratislava, Nem. Sv. Cyrila a Metoda | Bratislava, 851 07, Slovakia |
Withdrawn | Nemocnica Poprad, a.s. | Poprad, 058 45, Slovakia |
Completed | Hospital of LT University of Health Sciences Kaunas Clinics | Kaunas, LT-50161, Lithuania |
Completed | Vilnius University Hospital Santaros Klinikos | Vilnius, LT-08661, Lithuania |
Completed | RétinElysée | Lausanne, 1006, Switzerland |
Completed | Berner Augenklinik am Lindenhofspital | Bern, TBC, Switzerland |
Completed | Vista Klinik | Binningen, 4102, Switzerland |
Completed | Inselspital Universitätsspital Bern | Bern, 3010, Switzerland |
Completed | University Eye Hospital Jules Gonin | Lausanne, 1004, Switzerland |
Completed | AS Ida-Tallinna Keskhaigla - Oftalmoloogiakeskus | Tallinn, 10138, Estonia |
Terminated | Dr. Kai Noor Silmakabinet OÜ | Tallinn, 11412, Estonia |
Completed | Sihtasutus Tartu Ülikooli Kliinikum - Silmakliinik | Tartu, 50406, Estonia |
Completed | Riga East Clinical University Hospital "Gailezers" | Riga, LV-1038, Latvia |
Completed | Department of Ophthalmology | Riga, 1002, Latvia |
Withdrawn | Latvian American Eye Center | Riga, LV-1009, Latvia |
Withdrawn | University Multiprofile Hospital For Active Treatment 'Alexandrovska' EAD | Sofia, 1431, Bulgaria |
Completed | Magyar Honvedseg Egeszsegugyi Kozpont | Budapest, 1062, Hungary |
Completed | Clinique Rétine Tourny | BORDEAUX, 33000, France |
Completed | Clinique Jules Verne - Nantes | NANTES, 44000, France |
Withdrawn | Azienda Universitaria Ospedaliera Consorziale Policlinico Bari | Bari, 70124, Italy |
Completed | Azienda Ospedaliero Universitaria Delle Marche - Clinica Oculistica | Torrette, 60126, Italy |
Terminated | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milano, 20122, Italy |
Withdrawn | Azienda Ospedaliera Ordine Mauriziano Di Torino | Torino, 10128, Italy |
Completed | Instituto Oftalmologico Gomez-Ulla S.L. - Oftalmologia | Santiago de Compostela, 15706, Spain |
Completed | Hospital Clínic i Provincial de Barcelona | Barcelona, 8036, Spain |
Completed | Hospital Vall d'Hebron - Servei d'Oftalmologia | Barcelona, 08035, Spain |
Completed | Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice | Pardubice, 530 03, Czech Republic |
Completed | Fakultní nemocnice Královské Vinohrady - Urologická klinikay | Praha 10, 10034, Czech Republic |
Completed | Specialized Hospital For Active Treatment of Eye Diseases Zora | Sofia, 1784, Bulgaria |
Completed | Spec. Hosp. of Ophthalm. Disease for Active Treatment Varna | Varna, 9000, Bulgaria |
Completed | CHLC - Hospital dos Capuchos - Servico de Oftalmologia | Lisboa, 1169-050, Portugal |
Completed | Centro Hospitalar Vila Nova de Gaia e Espinho | Unit 1 - Clinical Research Center | Porto, 4434-502, Portugal |
Completed | Hanusch-Krankenhaus Wien | Wien, 1140, Austria |
Completed | Konventhospital Barmherzige Brüder Linz | Linz, 4021, Austria |
Completed | Medizinische Universität Graz | Graz, 8036, Austria |
Withdrawn | Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet | Budapest, 1024, Hungary |
Completed | Univerzitna nemocnica Bratislava, Nemocnica Ruzinov | Bratislava, 826 06, Slovakia |
Completed | Specialized hospital for ophthalmology OPHTAL | Zvolen, 96001, Slovakia |
Withdrawn | Turman Silmakliinik | Tallinn, 11314, Estonia |
Completed | Charles Retina Specialists – Germantown | Memphis, 38119, United States |
Completed | New England Retina Associates | New London, 06320, United States |
Completed | Rand Eye Institute | Deerfield Beach, 33064, United States |
Completed | Retina Vitreous Associates of Florida - Saint Petersburg | Saint Petersburg, 33711, United States |
Completed | Long Island Vitreoretinal Consultants - Great Neck | Great Neck, 11021, United States |
Completed | Mid Atlantic Retina Specialists - Hagerstown | Hagerstown, 21740, United States |
Completed | Vitreoretinal Consultants of NY - Hauppauge | Hauppauge, 11788, United States |
Completed | Florida Eye Associates - Melbourne Main Office | Melbourne, 32901, United States |
Completed | University of Wisconsin - Madison | Madison, 53792, United States |
Completed | Retina Consultants of Orange County - Fullerton | Fullerton, 92835, United States |
Completed | University Retina and Macula Associates | Oak Forest, 60452, United States |
Completed | Medical Center Ophthalmology Associates - Northwest | San Antonio, 78240, United States |
Completed | Retina Care Center | Baltimore, 21209, United States |
Completed | Retina Associates - Elmhurst | Elmhurst, 60126, United States |
Completed | Texas Retina Associates | Fort Worth, 76104, United States |
Completed | Fort Lauderdale Eye Institute | Plantation, 33324, United States |
Completed | Florida Retina Institute - Orlando | Orlando, 32806, United States |
Completed | East Florida Eye Institute | Stuart, 34994, United States |
Completed | Retina Consultants, LLC | Salem, 97302, United States |
Completed | Retina Center of New Jersey | Bloomfield, 07003, United States |
Completed | Retina Consultants of Texas - Bellaire | Bellaire, 77401, United States |
Completed | Retina Specialty Institute - Pensacola | Pensacola, 32503, United States |
Withdrawn | Southern California Permanente Medical Group | Riverside, 92505, United States |
Completed | Midwest Retina - Main Office | Dublin, 43016, United States |
Completed | Spokane Eye Clinical Research | Spokane, 99204, United States |
Completed | Northern California Retina Vitreous Associates - Mountain View Office | Mountain View, 94040, United States |
Completed | Palmetto Retina Center, LLC - Florence | Florence, 29501, United States |
Completed | Southern California Desert Retina Consultants - Palm Springs Office | Palm Springs, 92262, United States |
Completed | Tel-Aviv Sourasky Medical Center | Tel Aviv, 6423906, Israel |
Completed | Assuta Medical Centers - HaShalom | Tel Aviv, 6789140, Israel |
Completed | Eyeclinic Albury Wodonga | Albury, 2640, Australia |
Completed | Hobart Eye Surgeons | Hobart, 7000, Australia |
Completed | Sydney Retina Clinic | Sydney, 2000, Australia |
Completed | Strathfield Retina Clinic | Strathfield, 2135, Australia |
Completed | Adelaide Eye and Retina Centre | Adelaide, 5000, Australia |
Completed | Sydney West Retina Pty Ltd | Westmead, 2145, Australia |
Completed | Klinicki centar Vojvodine | Novi Sad, 21000, Serbia |
Completed | Clinical Center of Serbia | Belgrade, 11000, Serbia |
Completed | Clinical hospital center Zvezdara | Belgrade, 11000, Serbia |
Completed | Centrum Diagnostyki i Mikrochirurgii Oka Lens | Olsztyn, 10-424, Poland |
Completed | Prywatna Klinika Okulistyczna OFTALMIKA | Bydgoszcz, 85-631, Poland |
Withdrawn | NZOZ Poradnia Okulistyczna Dobry Wzrok | Gdansk, 80-402, Poland |
Completed | Gabinet Okulistyczny Prof. Edward Wylegala | Katowice, 40-594, Poland |
Completed | Centrum Medyczne Piasta 47 | Walbrzych, 58-304, Poland |
Completed | Centrum Medyczne PROMED | Krakow, 31-411, Poland |
Withdrawn | Colchester General Hospital | Colchester, CO4 5JR, United Kingdom |
Completed | Hull and East Yorkshire Eye Hospital Hull and East Yorkshire | Hull, HU32JZ, United Kingdom |
Completed | York Teaching Hospital | York, YO611DW, United Kingdom |
Completed | Cumberland Valley Retina Consultants | Hagerstown, MD | Hagerstown, 21740, United States |
Completed | Centrum Medyczne Dietla 19 Sp. z o.o. | Krakow, 31-070, Poland |
Completed | Osrodek Chirurgii Oka prof. Zagorskiego Sp. z o.o. | Rzeszow, 35-017, Poland |
Completed | Profesorskie Centrum Okulistyki | Gdansk, 80-809, Poland |
Completed | Specjalistyczny Osrodek Okulistyczny Oculomedica | Bydgoszcz, 85-870, Poland |
Completed | Hadassah Hebrew University Hospital Ein Kerem | Jerusalem, 9112001, Israel |
Completed | Rambam Health Corporation | Haifa, 3109601, Israel |
Completed | Meir Medical Center | Kfar Saba, 4428164, Israel |
Completed | Kaplan Medical Center | Rehovot, 7610001, Israel |
Active, not recruiting | Clalit Health | Soroka Medical Center - Internal Medicine Department | Beer Sheva, 8410101, Israel |
Completed | Hacettepe Universitesi Tip Fakultesi | Ankara, 6100, Turkey |
Withdrawn | Baskent Universitesi Tip Fakultesi Hastanesi | Ankara, 06490, Turkey |
Withdrawn | TianJin eye hospital | Tianjin, China |
Active, not recruiting | Guangzhou Aier Eye Hospital | Guangzhou, 634050, China |
Active, not recruiting | Henan Provincial Eye Hospital | Henan, 450008, China |
Active, not recruiting | People's Hospital of Ningxia Hui Autonomous Region - Opthalmology | Ningxia, 750002, China |
Active, not recruiting | Aier Eye Hospital (LIAONING) | Shenyang, N/A, China |
Active, not recruiting | ZheJiang Provincial People's Hospital | Hangzhou, 310014, China |
Active, not recruiting | Beijing Aier Intech Eye Hospital | Beijing, 100000, China |
Active, not recruiting | Beijing Hospital | Beijing, 100730, China |
Active, not recruiting | Eye Center of the second Bethune Hospital, jinlin University | Changchun, 130022, China |
Withdrawn | Tianjin Medical University General Hospital | Tianjin, 300052, China |
Completed | Seoul National University Bundang Hospital | Seongnam-si, 13620, Korea,_republic_of |
Completed | Asan Medical Center | Seoul, 05505, Korea,_republic_of |
Completed | Samsung Medical Center | Seoul, 06351, Korea,_republic_of |
Completed | Yeungnam University Medical Center | Daegu, 42415, Korea,_republic_of |
Completed | Kim's Eye Hospital | Seoul, 150-034, Korea,_republic_of |
Completed | LTD "IQ Clinic"- Ophthalmology | Tbilisi, 0162, Georgia |
Completed | LTD "Chichua Medical Center MZERA" | Tbilisi, 114, Georgia |
Completed | SBU Gulhane Egitim ve Arastirma Hastanesi | Ankara, 6010, Turkey |
Withdrawn | Istanbul Universitesi Istanbul Tip Fakultesi | Istanbul, 34093, Turkey |
Completed | Adnan Menderes Universitesi Tip fakultesi | Aydin, 9100, Turkey |
Completed | Ankara Numune Egitim ve Arastirma Hastanesi | Ankara, 6100, Turkey |
Withdrawn | Cukurova Universitesi Tip Fakultesi Hastanesi | Adana, TBC, Turkey |
Completed | Ankara Bilkent Sehir Hastanesi | Bilkent ankara, 6800, Turkey |
Withdrawn | Ankara Universitesi Tip Fakultesi Hastanesi | Ankara, 6100, Turkey |
Withdrawn | Gazi Universitesi Tip Fakultesi | Ankara, 6560, Turkey |
Completed | Kocaeli Universitesi Tip Fakultesi | Kocaeli, 41380, Turkey |
Withdrawn | Ege Universitesi Tip Fakultesi | Izmir, 35100, Turkey |
Withdrawn | Beyoglu Eye Training and Research Hospital | Istanbul, 34420, Turkey |
Completed | Pusan National University Hospital | Busan, 49241, Korea,_republic_of |
Completed | St. Mary Hospital | Seoul, 137-701, Korea,_republic_of |
Completed | Seoul National University Hospital | Seoul, 3080, Korea,_republic_of |
Completed | Korea University Ansan Hospital | Gyeonggi-do, 425-707, Korea,_republic_of |
Completed | Gangnam Severance Hospital, Yonsei University Health System | Seoul, 6273, Korea,_republic_of |
Completed | OasisEye Specialists | Kuala Lumpur, 59200, Malaysia |
Completed | Hospital Selayang | Shah Alam, 68100, Malaysia |
Completed | Chiangmai University | Chiangmai, 50200, Thailand |
Withdrawn | Thammasat University | Pathum Thani,, 12120, Thailand |
Completed | Srinagarind Hospital | Khon Kaen, 40002, Thailand |
Completed | Moorfields Eye Hospital | London, EC1V2PD, United Kingdom |
Withdrawn | Barnet General Hospital | London Borough Of Barnet, EN53DJ, United Kingdom |
Withdrawn | Epsom General Hospital | Epsom, KT18 7EG, United Kingdom |
Completed | Leicester Royal Infirmary | Leicester, LE1 5WW, United Kingdom |
Completed | Sunderland Eye Infirmary | Sunderland, SR29HP, United Kingdom |
Completed | Frimley Park Hospital NHS | Frimley, GU167UJ, United Kingdom |
Completed | Bradford Royal Infirmary | Bradford, BD9 6RJ, United Kingdom |
Withdrawn | University Hospitals Coventry and Warwickshire NHS Trust | Coventry, CV2 2DX, United Kingdom |
Withdrawn | James Paget Hospital | Great Yarmouth, NR316LA, United Kingdom |
Completed | Royal Liverpool University Hospital | Liverpool, L7 8XP, United Kingdom |
Completed | New Cross Hospital | Wolverhampton, WV100QP, United Kingdom |
Completed | Leeds Teaching Hospitals NHS Trust | St James's University Hospital - Oncology | Leeds, LS9 7TF, United Kingdom |
Completed | Retina Consultants of Southern California | Redlands, 92374, United States |
Withdrawn | Ophthalmic Consultants of the Capital Region | Troy, 12180, United States |
Completed | The Retina Group of Washington | Fairfax | Fairfax, 22031, United States |
Completed | NJ Retina | Teaneck | Teaneck, 07666, United States |
Completed | Retina Associates of Western New York | Rochester, 14620, United States |
Terminated | Ophthalmic Consultants of Long Island | Lynbrook, 11563, United States |
Completed | Retina Consultants of Nevada - Summerlin | Las Vegas, 89144, United States |
Completed | Retina Consultants of Southern Colorado, PC | Colorado Springs, 80909, United States |
Withdrawn | Wake Forest Baptist Health | Winston-Salem, 27157, United States |
Completed | Retina Consultants of Texas - Bellaire | Bellaire, 77401, United States |
Completed | Azul Vision Pasadena | Pasadena, 91107, United States |
Completed | Vitreo-Retinal Associates, PC | Grand Rapids, 49525, United States |
Completed | Retina Consultants of South Carolina - Ladson | Ladson, 29456, United States |
Completed | Retina Consultants of Texas - San Antonio Medical Center | San Antonio, 78240, United States |
Completed | Retina Associates - Lenexa | Lenexa, 66215, United States |
Completed | Center for Retina and Macular Disease - Winter Haven | Winter Haven, 33880, United States |
Completed | University of North Carolina at Chapel Hill (UNC) | Ophthalmology | Chapel Hill, 27599, United States |
Completed | South Coast Retina - Long Beach | Long Beach, 90807, United States |
Completed | Rocky Mountain Retina Consultants - Main Office | Salt Lake City, 84107, United States |
Completed | Marietta Eye Clinic | Marietta, 30060, United States |
Completed | Cincinnati Eye Institute - Blue Ash | Blue Ash, 45242-5664, United States |
Terminated | Palmetto Retina Center, LLC - Florence | Florence, 29501, United States |
Completed | Mid Atlantic Retina - Philadelphia / Wills Eye Hospital | Philadelphia, 19107, United States |
Withdrawn | University of South Florida | Tampa, 33612, United States |
Completed | Eye Associates of New Mexico - Albuquerque - Retina Center | Albuquerque, 87109, United States |
Withdrawn | Stanford University | Stanford, 94305, United States |
Completed | RCM - St. Louis Park Retina Clinic | St Louis Park, 55416, United States |
Completed | The Eye Institute of West Florida | Largo, 33770, United States |
Completed | Austin Retina Associates - Central | Austin, 78705, United States |
Withdrawn | University of Pennsylvania | Philadelphia, 19104, United States |
Completed | NJ Retina - New Brunswick | New Brunswick, 08901, United States |
Completed | National Ophthalmic Research Institute - Fort Myers | Fort Myers, 33912, United States |
Completed | Retina Consultants of Texas - Bellaire | Bellaire, 77401, United States |
Completed | Chofu Eye Clinic | Chofu, 182-0024, Japan |
Completed | Medical corporation Eiwakai Dannoue Ophthalmology clinic | Kawasaki, 211-0053, Japan |
Completed | Tokiwadai Muranaka Eye Clinic | Itabashi-ku, 174-0071, Japan |
Completed | The University of Tokyo Hospital | Bunkyo-ku, 113-8655, Japan |
Completed | National Defense Medical College Hospital | Tokorozawa, 359-8513, Japan |
Completed | Japanese Red Cross Nagasaki Genbaku Hospital | Nagasaki, 852-8511, Japan |
Completed | National Hospital Organization Tokyo Medical Center | Meguro-ku, 152-8902, Japan |
Completed | Hayashi Eye Hospital | Fukuoka, 812-0011, Japan |
Completed | Nagoya City University Hospital | Nagoya, 467-8602, Japan |
Completed | Osaka Metropolitan University Hospital | Osaka, 545-8586, Japan |
Completed | University of Miyazaki Hospital | Miyazaki, 889-1692, Japan |
Completed | Kozawa Eye Hospital and Diabetes Center | Mito, 310-0845, Japan |
Completed | Southern Tohoku Eye Clinic | Koriyama, 963-8052, Japan |
Completed | Mie University Hospital | Tsu, 514-8507, Japan |
Completed | Murakami Karindoh Hospital | Fukuoka, 819-8585, Japan |
Completed | Japanese Red Cross Wakayama Medical Center | Wakayama, 640-8558, Japan |
Completed | Hyogo Prefectural Amagasaki General Medical Center | Amagasaki, 660-8550, Japan |
Completed | Kagoshima University Hospital | Kagoshima, 890-8520, Japan |
Completed | University of Yamanashi Hospital | Chuo, 409-3898, Japan |
Completed | Fukushima Medical University Hospital | Fukushima, 960-1295, Japan |
Completed | Tokyo Medical University Hachioji Medical Center | Hachioji, 193-0998, Japan |
Withdrawn | Mie University Hospital | Tsu, 514-8507, Japan |
Completed | Kurume University Hospital | Kurume, 830-0011, Japan |
Completed | Akita University Hospital | Akita, 010-8543, Japan |
Completed | Shinshu University Hospital | Matsumoto, 390-8621, Japan |
Completed | Keio University Hospital | Shinjuku-ku, 160-8582, Japan |
Completed | Kagawa University Hospital | Kita-gun, 761-0793, Japan |
Completed | University of Fukui Hospital | Yoshida, 910-1193, Japan |
Completed | Tokyo Metropolitan Institute for Geriatrics and Gerontology | Itabashi-ku, 173-0015, Japan |
Completed | Yamaguchi University Hospital | Ube, 755-8505, Japan |
Completed | Kobe University Hospital | Kobe, 650-0017, Japan |
Completed | St. Marianna University Hospital | Kawasaki, 216-8511, Japan |
Completed | Japanese Red Cross Saitama Hospital | Saitama, 330-8553, Japan |
Completed | Yamagata University Hospital | Yamagata, 990-9585, Japan |
Completed | Nihon University Hospital | Chiyoda-ku, 101-8309, Japan |
Not yet recruiting | Shiga University of Medical Science Hospital | Otsu, 520-2192, Japan |
Completed | Shida Eye Clinic | Fujieda-shi, 426-0029, Japan |
Completed | Gunma University Hospital | Maebashi, 371-8511, Japan |
Completed | Hyogo Medical University Hospital | Nishinomiya, 663-8501, Japan |
Completed | Toho University Sakura Medical Center | Sakura, 285-8741, Japan |
Completed | Yokohama City University Medical Center | Yokohama, 232-0024, Japan |
Completed | Matsumoto Eye Clinic | Toride, 302-0014, Japan |
Completed | Shamir Medical Center (Assaf Harofeh) | Zerifin, 7030000, Israel |
Completed | Lady Davis Carmel Medical Center | Haifa, 3436212, Israel |
Completed | Edith Wolfson Medical Center | Internal Medicine Department | Holon, 5822012, Israel |
Completed | Rabin Medical Center | Beilinson Hospital - Internal Medicine C Department | Petach Tikva, 4941492, Israel |
Completed | Sydney Eye Hospital | Sydney, 2000, Australia |
Completed | Marsden Eye Surgery Center | Parramatta, 2150, Australia |
Completed | Centre for Eye Research | East Melbourne, 3002, Australia |
Completed | Lion Eye Institute | Nedlands, 6009, Australia |
Active, not recruiting | Lanzhou University - The Second Hospital (The Second Clinical Medical College of Lanzhou University) | Lanzhou, 730030, China |
Active, not recruiting | Capital Medical University (CMU) - Beijing Tongren Hospital | Beijing, 100062, China |
Withdrawn | The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an, 710061, China |
Withdrawn | The Affiliated Eye Hospital of Wenzhou Medical College | Wenzhou, China |
Active, not recruiting | Aier Eye Hospital (Chengdu) | Chengdu, N/A, China |
Withdrawn | The First People's Hospital of Xuzhou | Xuzhou, 221002, China |
Active, not recruiting | Shijiazhuang General Hospital | Shijiazhuang, 50000, China |
Active, not recruiting | The Second Hospital of Anhui medical university | Hefei, 230601, China |
Completed | Peking Union Medical College Hospital CAMS | Beijing, 100730, China |
Active, not recruiting | Tianjin Medical University Eye Hospital | Tianjin, 300384, China |
Active, not recruiting | The Fourth People's Hospital of Shenyang | Shenyang, 110082, China |
Active, not recruiting | Hebei eye hospital | Hebei, 050010, China |
Withdrawn | West China Hospital,Sichuan University | Chengdu, 610041, China |
Withdrawn | Second Hospital Affiliated of Chongqing Medical University | Chongqing, China |
Active, not recruiting | Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech. | Wuhan, 430030, China |
Active, not recruiting | Peking University First Hospital | Beijing, 100034, China |
Withdrawn | China Medical University (CMU) - First Affiliated Hospital | Shenyang, 110001, China |
Withdrawn | The First Affiliated Hospital of Chongqing Medical Universit | Chongqing, 401147, China |
Withdrawn | Eye & Ent Hospital of Fudan University | Shanghai, China |
Active, not recruiting | China-Japan Friendship Hospital | Beijing, 100029, China |
Completed | Chongqing Aier Ophthalmology Hospital | Chongqing, 400020, China |
Active, not recruiting | Qilu Hosp., Shandong Univ. | Jinan, 250000, China |
Withdrawn | Zhejiang University School of Medicine - The First Affiliated Hospital - Kidney Disease Center | Hangzhou, 310003, China |
Active, not recruiting | Shanxi Eye Hospital | Shanxi, 030002, China |
Active, not recruiting | Dongyang People's Hospital | Jinhua, 322199, China |
Completed | Severance Hospital, Yonsei University Health System | Seoul, 03722, Korea,_republic_of |
Withdrawn | LTD Israeli-Georgian Medical Research Clinic “Helsicore” | Tbilisi, 112, Georgia |
Withdrawn | Caucasus Medical Center- Opthamology | Tbilisi, N/A, Georgia |
Withdrawn | Renmin Hospital of Wuhan University | Wuhan, 430040, China |
Completed | Hospital Shah Alam | Ophthalmology | Shah Alam, 40000, Malaysia |
Withdrawn | Sierra Eye Associates | Reno, 89502, United States |
Completed | Hospital Al-Sultan Abdullah, UiTM | Opthalmology | Bandar Puncak Alam, 42300, Malaysia |
Withdrawn | Instituto de la Retina del Bajío SC | Queretaro, 76187, Mexico |
Withdrawn | Hospital Angeles Mocel | Oftalmologia | Mexico City, 11850, Mexico |
Withdrawn | Instituto Mexicano de Oftalmologia, IMO | Queretaro, 76090, Mexico |
Withdrawn | Fundacion Hospital Nuestra Señora de la Luz | Mexico City, 6030, Mexico |
Withdrawn | Instituto de Oftalmología FAP Conde de Valenciana, IAP. | Oftalmología | Mexico City, 06800, Mexico |
Withdrawn | Santa Lucia Clinica | Oftalmologica | Guadalajara, 44670, Mexico |
Completed | Ankara Etlik City Hospital | Ophthalmology | Ankara, 06170, Turkey |
Withdrawn | Universitätsmedizin Göttingen - Ophthalmology | Göttingen, 37075, Germany |
Withdrawn | Medizinische Hochschule Hannover (MHH) - Universitätsklinik für Augenheilkunde | Hannover, 30625, Germany |
Completed | Klinikum d. Stadt Ludwigshafen - Ophthalmology | Ludwigshafen, 67063, Germany |
Withdrawn | Universitaetsklinikum Tuebingen - Ophthalmology | Tuebingen, 72076, Germany |
Completed | Uniklinik Bonn / Eye Clinic | Bonn, 53127, Germany |
Completed | St. Franziskus-Hospital Münster - Eye Center | Muenster, 48145, Germany |
Withdrawn | Universitätsklinikum Düsseldorf / Ophthalmology | Düsseldorf, 40225, Germany |
Withdrawn | Universitätsklinikum Freiburg | Freiburg, 79106, Germany |
Withdrawn | Universitätsklinik Gießen und Marburg GmbH (UKGM) - Ophthalmology | Marburg, 35043, Germany |
Completed | Uni Heidelberg / Augenklinik | Heidelberg, Germany |
Withdrawn | Ludwig-Maximilians-Universitaet Muenchen (LMU) Klinikum - Eye Clinic and Polyclinic | Munich, 80336, Germany |
Withdrawn | Universitaetsklinikum Jena - Ophthalmology | Jena, 07747, Germany |
Completed | Knappschaftskrankenhaus Sulzbach | Sulzbach, 66280, Germany |
Withdrawn | University of Chicago | Chicago, 60637-1447, United States |
Withdrawn | Beijing Tongren Hospital, Capital Medical University (West) | Beijing, 100730, China |
Completed | International University of Health and Welfare Narita Hospital | Narita, 286-8520, Japan |
Completed | Tokyo Women's Medical University Hospital | Shinjuku-ku, 162-8666, Japan |
Not yet recruiting | Okayama University Hospital | Okayama, 700-8558, Japan |
Not yet recruiting | Toyama University Hospital | Toyama, 930-0194, Japan |
Not yet recruiting | Aichi Medical University Hospital | Nagakute, 480-1195, Japan |
Primary Outcome
- Change from baseline in BCVA measured by the ETDRS letter score at Week 36BCVA: 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)date_rangeTime Frame:At Week 36
Secondary Outcome
- Number of active injections from baseline to Week 64date_rangeTime Frame:From baseline to Week 64
- Number of active injections from baseline to Week 36date_rangeTime Frame:From baseline to Week 36
- Change from baseline in BCVA measured by the ETDRS letter score at Week 44ETDRS letter score (ranging from 0 to 100 letters). A higher letter score means a better outcome (better visual acuity)date_rangeTime Frame:At baseline, week 44
- Change from baseline in BCVA measured by the ETDRS letter score at Week 64ETDRS letter score (ranging from 0 to 100 letters). A higher letter score means a better outcome (better visual acuity)date_rangeTime Frame:At baseline, week 64
- Number of participants gaining at least 15 letters in BCVA from baseline at Weeks 36 and 64date_rangeTime Frame:From baseline at week 36 and week 64
- Number of participant achieving an ETDRS letter score of at least 69 (approximate 20/40 Snellen equivalent) at Weeks 36 and 64ETDRS letter score (ranging from 0 to 100 letters). A higher letter score means a better outcome (better visual acuity)date_rangeTime Frame:At week 36 and week 64
- Participant having no IRF and no SRF in the center subfield at Weeks 36 and 64 (yes/no)date_rangeTime Frame:At week 36 and week 64
- Change from baseline in CST at Weeks 36 and 64CST: Central Sub-field Thickness;date_rangeTime Frame:At baseline, week 36 and week 64
- Change from baseline in NEI VFQ 25 total score at Weeks 36 and 64NEI-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).date_rangeTime Frame:At baseline, week 36 and week 64
- Number of participant with TEAEs and SAEs through Weeks 36 and 64date_rangeTime Frame:Through weeks 36 and 64
- Participants dosed only Q8W through Week 36 in the 8 mg Q8W groupdate_rangeTime Frame:Through weeks 36
- Participants having last treatment intervals ≥12 or of 16 weeks at Week 64date_rangeTime Frame:At week 64
- Participants having next intended interval ≥12 or of 16 weeks at Week 64date_rangeTime Frame: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 64date_rangeTime Frame:From baseline through weeks 36 and 64
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
3