Trial Condition(s):
Neovascular Age-Related Macular Degeneration
Study to gather information on safety and use of high dose aflibercept injection into the eye in patients with an age related eye disorder that causes blurred vision or a blind spot due to abnormal blood vessels that leak fluid into the light sensitive lining inside the eye (PULSAR)
Bayer Identifier:
20968
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
In this study researchers want to learn more about changes in visual acuity (clarity of vision) with a high dose treatment with Aflibercept (Eylea) in patients suffering from neovascular age-related macular degeneration (nAMD). Neovascular AMD is an eye disease that causes blurred vision or a blind spot due to abnormal blood vessels that leak fluid or blood into the light sensitive lining inside the eye (retina). The fluid buildup causes the central part of the retina (macula) responsible for sharp, straight-ahead vision to swell and thicken (edema), which distorts vision.
Inclusion Criteria
- Active subfoveal CNV secondary to nAMD, including juxtafoveal lesions that affect the fovea as assessed in the study eye. - Total area of CNV (including both classic and occult components) must comprise greater than 50% of the total lesion area in the study eye. - BCVA ETDRS letter score of 78 to 24 (corresponding to a Snellen equivalent of approximately 20/32 to 20/320) in the study eye. - Decrease in BCVA determined to be primarily the result of nAMD in the study eye. - Presence of IRF and/or SRF affecting the central subfield of the study eye on OCT. - Contraceptive use by men or women should be consistent with local regulations regarding the methods of highly effective contraception for those participating in clinical studies. - Other protocol-specified inclusion criteria. Additional inclusion criteria for Year 3: - At least one BCVA value and one central subfield retinal thickness (CST) value from measurements at one of the following visits: Visit 24 (Week 84), Visit 25 (Week 88) or Visit 26 (Week 92). - Participant is enrolled at a site that participates in the extension period.
Exclusion Criteria
- Causes of CNV other than nAMD in the study eye. - Scar, fibrosis, or atrophy involving the central subfield in the study eye. - Presence of retinal pigment epithelial tears or rips involving the central subfield in the study eye. - Uncontrolled glaucoma (defined as IOP >25 mmHg despite treatment with anti-glaucoma medication) in the study eye. - History of idiopathic or autoimmune uveitis in the study eye. - Myopia of a spherical equivalent of at least 8 diopters in the study eye prior to any refractive or cataract surgery. - History or clinical evidence of diabetic retinopathy, diabetic macular edema, or any retinal vascular disease other than nAMD in either eye. - Evidence of extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening/randomization. - Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg). - Any prior or concomitant ocular (in the study eye) or systemic treatment (with an investigational or approved, anti-VEGF or other agent) or surgery for nAMD, except dietary supplements or vitamins. - Other protocol-specified exclusion criteria
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Kobe University Hospital Kobe, Japan, 650-0017 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hyogo Prefectural Amagasaki General Medical Center Amagasaki, Japan, 660-8550 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nagoya City University Hospital Nagoya, Japan, 467-8602 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of the Ryukyus Hospital Nakagami, Japan, 903-0215 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AXON Clinical s.r.o. Praha 5, Czech Republic, 150 00 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Ostrava Ostrava, Czech Republic, 708 52 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni Nemocnice Hradec Kralove Hradec Kralove, Czech Republic, 500 05 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Charles University in Prague Prague, Czech Republic, 110 00 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sydney Retina Clinic Sydney, Australia, 2000 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Marsden Eye Surgery Center Parramatta, Australia, 2150 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Westmead Hospital Westmead, Australia, 2145 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eyeclinic Albury Wodonga Albury, Australia, 2640 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hobart Eye Surgeons Hobart, Australia, 7000 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinikum Klagenfurt am Wörthersee Klagenfurt, Austria, 9020 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pusan National University Hospital Busan, South Korea, 49241 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Asan Medical Center Seoul, South Korea, 05505 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Samsung Medical Center Seoul, South Korea, 06351 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seoul National University Hospital Seoul, South Korea, 03080 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seoul National University Bundang Hospital Seongnam-si, South Korea, 13620 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Samsung Medical Center Seoul, South Korea, 06351 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations New England Retina Associates New London, United States, 06320 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ophthalmic Consultants of Boston Boston, United States, 02114 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Palmetto Retina Center, LLC West Columbia, United States, 29169 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medical Center Ophthalmology Associates San Antonio, United States, 78240 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hayashi Eye Hospital Fukuoka, Japan, 812-0011 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Daiyukai Daiichi Hospital Ichinomiya, Japan, 491-8551 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Hospital Organization Tokyo Medical Center Meguro-ku, Japan, 152-8902 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultna nemocnica Trencin Trencin, Slovakia, 911 71 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Stadtspital Triemli Zürich, Switzerland, 8063 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chang Gung Memorial Hospital at Linkou Taoyuan, Taiwan, China, 33305 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shin Kong Wu Ho-Su Memorial Hospital Taipei City, Taiwan, China, 111 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National University Hospital Singapore, Singapore, 119074 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Organizacion Medica de Investigacion (OMI) Buenos Aires, Argentina, C1015ABO | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Konventhospital Barmherzige Brüder Linz Linz, Austria, 4021 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hanusch-Krankenhaus Wien Wien, Austria, 1140 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mie University Hospital Tsu, Japan, 514-8507 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Akita University Hospital Akita, Japan, 010-8543 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nagoya University Hospital Nagoya, Japan, 466-8560 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kansai Medical University Hospital Hirakata, Japan, 573-1191 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hiroshima University Hospital Hiroshima, Japan, 734-8551 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AIBILI Coimbra, Portugal, 3000-548 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Oita University Hospital Yufu, Japan, 879-5593 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taipei Veterans General Hospital Taipei, Taiwan, China, 11217 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fukushima Medical University Hospital Fukushima, Japan, 960-1295 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Okayama University Hospital Okayama, Japan, 700-8558 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kurume University Hospital Kurume, Japan, 830-0011 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Yamaguchi University Hospital Ube, Japan, 755-8505 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kanazawa University Hospital Kanazawa, Japan, 920-8641 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Kralovske Vinohrady Praha 10, Czech Republic, 10034 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital of LT University of Health Sciences Kaunas Clinics Kaunas, Lithuania, LT-50161 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vilnius University Hospital Santaros Klinikos Vilnius, Lithuania, LT-08661 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations PI Klaipedos University Hospital Klaipeda, Lithuania, LT-92288 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations East Tallinn Central Hospital Tallinn, Estonia, 10138 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Latvian American Eye Center Riga, Latvia, LV-1009 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Department of Ophthalmology Riga, Latvia, 1002 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Long Island Vitreoretinal Consultants Great Neck, United States, 11021 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ophthalmic Consultants of Long Island Lynbrook, United States, 11563 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Long Island Vitreoretinal Consultants Hauppauge, United States, 11788 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations NJ Retina Edison, United States, 08820 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Texas Retina Associates Fort Worth, United States, 76104 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Northwest, PC Portland, United States, 97210 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Care Center Baltimore, United States, 21209 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Consultants of Nevada Las Vegas, United States, 89144 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Center of New Jersey Bloomfield, United States, 07003 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Vitreous Associates of Florida - Saint Petersburg Saint Petersburg, United States, 33711-1141 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations West Virginia University Morgantown, United States, 26506 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Spokane Eye Clinical Research Spokane, United States, 99204 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Arizona Retina and Vitreous Consultants - Research Phoenix, United States, 85021 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Florida Retina Institute Jacksonville, United States, 32204 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations California Eye Specialists Pasadena, United States, 91107 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retinal Consultants of Texas - San Antonio San Antonio, United States, 78240 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mid Atlantic Retina Bethlehem, United States, 18017 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Consultants of Houston Houston, United States, 77030 | Status Active, not recruiting | Contact Us: E-mail: clinical-tri[email protected] Phone: (+)1-888-84 22937 |
Locations Charles Retina Institute Memphis, United States, 38119 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Consultants of Houston The Woodlands, United States, 77384 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vitreo Retinal Surgery PA Edina, United States, 55435 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Consultants San Diego San Diego, United States, 92071 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Retina and Macula Associates Oak Forest, United States, 60452 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Florida Retina Institute Orlando, United States, 32806 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Southern Vitreoretinal Associates Tallahassee, United States, 32308 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vitreo-Retinal Associates Gainesville, United States, 32607 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Group of Florida Ft. Lauderdale, United States, 33308 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vanderbilt University Medical School Nashville, United States, 37232 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eye Associates of New Mexico Albuquerque, United States, 87106 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Black Hills Regional Eye Institute Rapid City, United States, 57701 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eye Care Specialists Kingston, United States, 18704 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Northern California Retina-Vitreous Associates Mountain View, United States, 94040 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Charleston Neuroscience Center Charleston, United States, 29414 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Macula Specialists of Miami Miami, United States, 33126 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Midwest Retina - Main Office Dublin, United States, 43016 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Consultants of Hawaii Aiea, United States, 96701 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fletcher Allen Health Care Burlington, United States, 05401-1420 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Associates IL Elmhurst, United States, 60126 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Florida Eye Associates Melbourne, United States, 32901 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Erie Retinal Surgery, Inc. Erie, United States, 16507 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Austin Retina Associates Austin, United States, 78705 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Consultants of Southern California Redlands, United States, 92374 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Wisconsin - Madison Madison, United States, 53792 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Wake Forest Baptist Health Winston-Salem, United States, 27157-1045 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of California San Diego La Jolla, United States, 92093-0698 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Specialists Pensacola, United States, 32503 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Consultants of Orange County Fullerton, United States, 92835 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ophthalmic Consultants of the Capital Region Troy, United States, 12180 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Consultants, LLC Salem, United States, 97302 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kaiser Permanente Riverside Medical Center Riverside, United States, 92505 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kozawa Eye Hospital and Diabetes Center Mito, Japan, 310-0845 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The University of Tokyo Hospital Bunkyo-ku, Japan, 113-8655 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kansai Medical University Medical Center Moriguchi, Japan, 570-8507 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kindai University Hospital Osakasayama, Japan, 589-8511 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aichi Medical University Hospital Nagakute, Japan, 480-1195 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lexum a.s., Evropska ocni klinika Praha 4, Czech Republic, 140 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Plzen - Lochotin Plzen, Czech Republic, 304 60 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Szent-Gyorgyi Albert Orvostudomanyi Egyetem Szeged, Hungary, 6720 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tartu University Hospital Tartu, Estonia | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Riga East Clinical University Hospital "Gailezers" Riga, Latvia, LV-1006 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shinshu University Hospital Matsumoto, Japan, 390-8621 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Japanese Red Cross Saitama Hospital Saitama, Japan, 330-8553 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kokura Memorial Hospital Kitakyushu, Japan, 802-8555 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Japanese Red Cross Nagasaki Genbaku Hospital Nagasaki, Japan, 852-8511 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Japanese Red Cross Wakayama Medical center Wakayama, Japan, 640-8558 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Singapore National Eye Centre Singapore, Singapore, 168751 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Miyazaki Hospital Miyazaki, Japan, 889-1692 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Keio University Hospital Shinjuku-ku, Japan, 160-8582 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi Poltava, Ukraine, 36011 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centralna Polyclinica MVS Ukraiiny Kyiv, Ukraine, 01024 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ospedale San Raffaele s.r.l. Milano, Italy, 20132 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione PTV Policlinico Tor Vergata Roma, Italy, 00133 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Fondazione G.B. Bietti Studio e Ricerca in Otalmologia Roma, Italy, 00198 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O. di Perugia Perugia, Italy, 06129 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. di Cagliari Cagliari, Italy, 09124 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ALM Oftalmolaser - Oftalmologia Medica e Cirurgica Lisboa, Portugal, 1050-078 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Hospitalar Universitario do Porto Porto, Portugal, 4099-001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Hospitalar Vila Nova de Gaia/Espinho | Unit 1 - Clinical Research Office Porto, Portugal, 4434-502 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultna nemocnica s poliklinikou Zilina Zilina, Slovakia, 012 07 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultna nemocnica Nitra Nitra, Slovakia, 950 01 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nemocnica s Poliklinikou Trebisov, Svet zdravia a.s. Trebisov, Slovakia, 075 01 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Yamanashi Hospital Chuo, Japan, 409-3898 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kanazawa Medical University Hospital Kahoku-gun, Japan, 920-0293 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Otakeganka Tsukimino Clinic Yamato, Japan, 242-0001 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kagawa University Hospital Kita-gun, Japan, 761-0793 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma, Italy, 00168 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASST Fatebenefratelli Sacco Milano, Italy, 20157 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nara Medical University Hospital Kashihara, Japan, 634-8522 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tokushima University Hospital Tokushima, Japan, 770-8503 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gunma University Hospital Maebashi, Japan, 371-8511 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medical corporation Eiwakai Dannoue Ophthalmology clinic Kawasaki, Japan, 211-0053 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tokiwadai Muranaka Eye Clinic Itabashi-ku, Japan, 174-0071 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kurashiki Medical Center Kurashiki, Japan, 710-8522 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kepler Universitätsklinikum Campus III Linz, Austria, 4020 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital de la Santa Creu i Sant Pau | Gynecology Department Barcelona, Spain, 8041 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 8036 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Reina Sofía Córdoba, Spain, 14004 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Miguel Servet Zaragoza, Spain, 50009 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital General Universitario de Valencia Valencia, Spain, 46014 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Instituto Oftalmológico Francisco Gomez Ulla Santiago de Compostela, Spain, 15706 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitari i Politècnic La Fe Valencia, Spain, 46026 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Meir Medical Center Kfar Saba, Israel, 4428164 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chaim Sheba Medical Center Ramat Gan, Israel, 5262000 | Status Active, not recruiting | Contact Us: E-mail: clinical-tri[email protected] Phone: (+)1-888-84 22937 |
Locations Assuta Medical Centers - HaShalom Tel Aviv, Israel, 6789140 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lady Davis Carmel Medical Center Haifa, Israel, 3436212 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Rambam Health Corporation Haifa, Israel, 3109601 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kaplan Medical Center Rehovot, Israel, 7610001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hadassah Hebrew University Hospital Ein Kerem Jerusalem, Israel, 9112001 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations RétinElysée Lausanne, Switzerland, 1006 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Berner Augenklinik am Lindenhofspital Bern, Switzerland | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Inje University Haeundae Paik Hospital Busan, South Korea, 612-862 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Center Nune Eye Hospital Seoul, South Korea, 135-280 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SEHAT Pentagram Sofia, Bulgaria, 1309 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sveta Petka Eye Hospital Varna, Bulgaria, 9002 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiprofile Hospital for Active Treatment Sveta Sofia Sofia, Bulgaria, 1618 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UMHAT Alexandrovska EAD Sofia, Bulgaria, 1431 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Specialized Hospital For Active Treatment of Eye Diseases Zora Sofia, Bulgaria, 1784 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Spec. Hosp. for Active Treatment for Eye Diseases Zrenie Sofia, Bulgaria, 1408 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St.Joseph's Health Care-London London, Canada, N6A 4V2 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Toronto Retina Institute Toronto, Canada, M3C 0G9 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut de l'Oeil des Laurentides Boisbriand, Canada, J7H 1S6 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Scientific Research Institution of Ophthalmic Diseases Moscow, Russia, 119021 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations FBSI IRTC Eye Microsurgery n.a. acad. S.N. Fyodorov Moscow, Russia, 127486 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Southern Tohoku Eye Clinic Koriyama, Japan, 963-8052 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical hospital center Zvezdara Belgrade, Serbia, 11000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Center of Serbia Belgrade, Serbia, 11000 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinicki centar Vojvodine Novi Sad, Serbia, 21000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St.Luke's International Hospital Chuoku, Japan, 104-8560 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LTD "Innova" Tbilisi, Georgia, 105 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LTD "Chichua Medical Center MZERA" Tbilisi, Georgia, 114 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations JSC "Evex Hospitals' Tbilisi, Georgia, 0186 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LTD "Clinic LJ" Kutaisi, Georgia, 4600 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tokyo Women's Medical University Hospital Shinjuku-ku, Japan, 162-8666 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Yamagata University Hospital Yamagata, Japan, 990-9585 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sapporo City General Hospital Sapporo, Japan, 060-8604 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nishikasai Inouye Eye Hospital Edogawa-ku, Japan, 134-0088 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shanghai General Hospital Shanghai, China, 200080 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations TianJin eye hospital Tianjin, China | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Affiliated Eye Hospital of Wenzhou Medical College Wenzhou, China | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Peking University People's Hospital Beijing, China, 100044 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tianjin Medical University Eye Hospital Tianjin, China, 300384 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Consultants of Southern Colorado, PC Colorado Springs, United States, 80909 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Wolfe Eye Clinic, PC West Des Moines, United States, 50266 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations OFTALMOS, Instituto Oftalmologico de Alta Complejidad Buenos Aires, Argentina, C1120AAN | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tokyo Medical University Hachioji Medical Center Hachioji, Japan, 193-0998 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations KKR Sapporo Medical Center Sapporo, Japan, 062-0931 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Espaco Medico de Coimbra Coimbra, Portugal, 3000-548 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Marianna University Hospital Kawasaki, Japan, 216-8511 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Guangzhou Aier Eye Hospital Guangzhou, China, 634050 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre d'Ophtalmologie - Paradis-Monticelli MARSEILLE, France, 13008 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre ophtalmologique Saint-Exupéry Saint-Cyr-Sur-Loire, France, 37540 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Private enterprise private production company " Acinus" Kropyvnytskyi, Ukraine, 25006 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Union Hospt Tongji Medical Colleg. Huazhong univ. Scien&Tech Wuhan, China, 430022 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Henan Provincial Ophthalmology Hospital (Henan Eye Institute Zhengzhou, China, 450003 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The First Affiliated Hospital of Xinjiang Medical University Urumqi, China, 830054 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Beijing Hospital Beijing, China, 100730 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eye Center of the second Bethune Hospital, jinlin University Changchun, China, 130022 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tianjin Medical University General Hospital Tianjin, China, 300052 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech. Wuhan, China, 430030 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The People's Hospital of Ningxia Hui Autonomous Region Yinchuan, China, 750000 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Beijing Aier Intech Eye Hospital Co. LTD - Ophthalmology Beijing, China, 100021 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aier Eye Hospital (Chengdu) Chengdu, China | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SHENYANG HE EYE HOSPITAL Shenyang, China, 110034 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ZheJiang Provincial People's Hospital Hangzhou, China, 310014 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The 1st Affiliated Hospital of Zhejiang University Hangzhou, China, 310000 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The 1st Affiliated Hospital Fujian Medical University Fuzhou, China | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chongqing Aier Ophthalmology Hospital Chongqing, China, 400000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Beijing Tongren Hospital, Capital Medical University (East) Beijing, China, 100005 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Second Hospital of Anhui medical university Hefei, China, 230601 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The First People's Hospital of Xuzhou Xuzhou, China, 221002 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hebei Eye Hospital Xingtai, China | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jiangxi Provincial People’s Hospital Nanchang, China, 330006 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The First Affiliated Hospital of NanChang University Nanchang, China, 330006 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The First Affiliated Hospital of Xi'an Jiaotong University Xi'an, China, 710061 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shanghai Tongji Hospital of Tongji University Shanghai, China, 200065 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tonghua Central Hospital Tonghua, China | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shijiazhuang General Hospital Shijiazhuang, China, 050000 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Lariboisière - Paris PARIS, France, 75475 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Budapest Retina Associates Budapest, Hungary, 1133 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Rand Eye Institute Deerfield Beach, United States, 33064 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of High Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Change in best corrected visual acuity (BCVA) measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter scoreTimeframe: At baseline and week 48
Secondary Outcome
- Change in BCVA measured by the ETDRS letter scoreTimeframe: At baseline and week 60
- Proportion of participants with no intraretinal fluid (IRF) and no subretinal fluid (SRF) in central subfieldTimeframe: At week 16
- Proportion of participants gaining at least 15 letters in BCVATimeframe: At baseline and week 48
- Proportion of participants achieving an ETDRS letter score of at least 69Timeframe: At week 48
- Change in choroidal neovascularization (CNV) sizeTimeframe: At baseline and week 48
- Change in total lesion areaTimeframe: At baseline and week 48
- Proportion of participants with no IRF and no SRF in the center subfieldTimeframe: At week 48
- Change in central subfield retinal thickness (CST)Timeframe: At baseline and week 48
- Change in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) total scoreTimeframe: At baseline and week 48
- Treatment-emergent adverse events (AEs) and serious AEs (SAEs)Timeframe: Up to 156 weeks
- Systemic exposure to aflibercept as assessed by plasma concentrationTimeframe: Up to week 48
- Assessment of immunogenicity to aflibercept by measuring the incidence of treatment-emergent anti-drug antibodies (ADA) responseTimeframe: Up to week 96
Additional Information
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