Trial Condition(s):
Neovascular Age-Related Macular Degeneration
Study of the effects of high dose aflibercept injected into the eye of patients with an age-related disorder that causes loss of vision due to growth of abnormal blood vessels at the back of 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 | |
|---|---|
Locations Kobe University Hospital Kobe, Japan, 650-0017 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hyogo Prefectural Amagasaki General Medical Center Amagasaki, Japan, 660-8550 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nagoya City University Hospital Nagoya, Japan, 467-8602 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of the Ryukyus Hospital Nakagami, Japan, 903-0215 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AXON Clinical s.r.o. Praha 5, Czech Republic, 150 00 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Ostrava Ostrava, Czech Republic, 708 52 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni Nemocnice Hradec Kralove Hradec Kralove, Czech Republic, 500 05 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Charles University in Prague Prague, Czech Republic, 110 00 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sydney Retina Clinic Sydney, Australia, 2000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Marsden Eye Surgery Center Parramatta, Australia, 2150 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Westmead Hospital Westmead, Australia, 2145 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eyeclinic Albury Wodonga Albury, Australia, 2640 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hobart Eye Surgeons Hobart, Australia, 7000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinikum Klagenfurt am Wörthersee Klagenfurt, Austria, 9020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pusan National University Hospital Busan, South Korea, 49241 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Asan Medical Center Seoul, South Korea, 138-736 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Samsung Medical Center Seoul, South Korea, 6351 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seoul National University Hospital Seoul, South Korea, 03080 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seoul National University Bundang Hospital Seongnam-si, South Korea, 13620 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations New England Retina Associates New London, United States, 06320 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ophthalmic Consultants of Boston Boston, United States, 02114 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Palmetto Retina Center, LLC West Columbia, United States, 29169 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medical Center Ophthalmology Associates San Antonio, United States, 78240 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hayashi Eye Hospital Fukuoka, Japan, 812-0011 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Daiyukai Daiichi Hospital Ichinomiya, Japan, 491-8551 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Hospital Organization Tokyo Medical Center Meguro-ku, Japan, 152-8902 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultna nemocnica Trencin Trencin, Slovakia, 911 71 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Stadtspital Triemli Zürich, Switzerland, 8063 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chang Gung Memorial Hospital at Linkou Taoyuan, Taiwan, China, 33305 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shin Kong Wu Ho-Su Memorial Hospital Taipei, Taiwan, China, 111 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National University Hospital Singapore, Singapore, 119074 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Organizacion Medica de Investigacion (OMI) Buenos Aires, Argentina, C1015ABO | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Konventhospital Barmherzige Brüder Linz Linz, Austria, 4021 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hanusch-Krankenhaus Wien Wien, Austria, 1140 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mie University Hospital Tsu, Japan, 514-8507 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Akita University Hospital Akita, Japan, 010-8543 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nagoya University Hospital Nagoya, Japan, 466-8560 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kansai Medical University Hospital Hirakata, Japan, 573-1191 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hiroshima University Hospital Hiroshima, Japan, 734-8551 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AIBILI Coimbra, Portugal, 3000-548 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Oita University Hospital Yufu, Japan, 879-5593 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taipei Veterans General Hospital Taipei, Taiwan, China, 11217 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fukushima Medical University Hospital Fukushima, Japan, 960-1295 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Okayama University Hospital Okayama, Japan, 700-8558 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kurume University Hospital Kurume, Japan, 830-0011 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Yamaguchi University Hospital Ube, Japan, 755-8505 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kanazawa University Hospital Kanazawa, Japan, 920-8641 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Kralovske Vinohrady Praha 10, Czech Republic, 10034 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vilnius University Hospital Santaros Klinikos Vilnius, Lithuania, LT-08661 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations PI Klaipedos University Hospital Klaipeda, Lithuania, LT-92288 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations East Tallinn Central Hospital Tallinn, Estonia, 10138 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Latvian American Eye Center Riga, Latvia, LV-1009 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Department of Ophthalmology Riga, Latvia, 1002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Long Island Vitreoretinal Consultants Great Neck, United States, 11021 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ophthalmic Consultants of Long Island Lynbrook, United States, 11563 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Long Island Vitreoretinal Consultants - Hauppauge Hauppauge, United States, 11788 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations NJ Retina Edison, United States, 08820 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Texas Retina Associates Fort Worth, United States, 76104 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Northwest, PC Portland, United States, 97210 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Care Center Baltimore, United States, 21209 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Consultants of Nevada Las Vegas, United States, 89144 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Center of New Jersey Bloomfield, United States, 07003 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations West Virginia University Morgantown, United States, 26505 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Spokane Eye Clinical Research Spokane, United States, 99204 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Arizona Retina and Vitreous Consultants - Research Phoenix, United States, 85021 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Florida Retina Institute Jacksonville, United States, 32204 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations California Eye Specialists Pasadena, United States, 91107 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retinal Consultants of Texas - San Antonio San Antonio, United States, 78240 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mid Atlantic Retina Bethlehem, United States, 18017 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Consultants of Texas - The Woodlands The Woodlands, United States, 77384 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Charles Retina Institute Memphis, United States, 38119 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Consultants of Houston The Woodlands, United States, 77384 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vitreo Retinal Surgery PA Edina, United States, 55435 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Consultants San Diego Poway, United States, 92064 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Retina and Macula Associates Oak Forest, United States, 60452 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Florida Retina Institute Orlando, United States, 32806 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Southern Vitreoretinal Associates Tallahassee, United States, 32308 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vitreo-Retinal Associates Gainesville, United States, 32607 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Group of Florida Ft. Lauderdale, United States, 33308 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vanderbilt University Medical School Nashville, United States, 37232 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eye Associates of New Mexico Albuquerque, United States, 87109-5853 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Black Hills Regional Eye Institute Rapid City, United States, 57701-7374 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eye Care Specialists Kingston, United States, 18704 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Northern California Retina-Vitreous Associates Mountain View, United States, 94040 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Charleston Neuroscience Center Charleston, United States, 29414 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Macula Specialists of Miami Miami, United States, 33126 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Midwest Retina - Main Office Dublin, United States, 43016 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Consultants of Hawaii Aiea, United States, 96701 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fletcher Allen Health Care Burlington, United States, 05401-1420 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Associates IL Elmhurst, United States, 60126 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Florida Eye Associates Melbourne, United States, 32901 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Erie Retinal Surgery, Inc. Erie, United States, 16507 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Austin Retina Associates Austin, United States, 78705 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Consultants of Southern California Redlands, United States, 92374 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Wisconsin - Madison Madison, United States, 53792 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Wake Forest Baptist Health Winston-Salem, United States, 27103 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of California San Diego La Jolla, United States, 92093-0698 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Specialists Pensacola, United States, 32503 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Consultants of Orange County Fullerton, United States, 92835 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ophthalmic Consultants of the Capital Region Troy, United States, 12180 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Consultants, LLC Salem, United States, 97302-2152 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kaiser Permanente Riverside Medical Center Riverside, United States, 92505 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kozawa Eye Hospital and Diabetes Center Mito, Japan, 310-0845 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The University of Tokyo Hospital Bunkyo-ku, Japan, 113-8655 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kansai Medical University Medical Center Moriguchi, Japan, 570-8507 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kindai University Hospital Osakasayama, Japan, 589-8511 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aichi Medical University Hospital Nagakute, Japan, 480-1195 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lexum a.s., Evropska ocni klinika Praha 4, Czech Republic, 140 00 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Plzen - Lochotin Plzen, Czech Republic, 32300 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Szent-Gyorgyi Albert Orvostudomanyi Egyetem Szeged, Hungary, 6720 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tartu University Hospital Tartu, Estonia | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Riga East Clinical University Hospital "Gailezers" Riga, Latvia, LV-1006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shinshu University Hospital Matsumoto, Japan, 390-8621 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Japanese Red Cross Saitama Hospital Saitama, Japan, 330-8553 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kokura Memorial Hospital Kitakyushu, Japan, 802-8555 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Japanese Red Cross Nagasaki Genbaku Hospital Nagasaki, Japan, 852-8511 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Japanese Red Cross Wakayama Medical center Wakayama, Japan, 640-8558 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Singapore National Eye Centre Singapore, Singapore, 168751 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Miyazaki Hospital Miyazaki, Japan, 889-1692 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Keio University Hospital Shinjuku-ku, Japan, 160-8582 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi Poltava, Ukraine, 36011 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centralna Polyclinica MVS Ukraiiny Kyiv, Ukraine, 01024 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ospedale San Raffaele s.r.l. Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione PTV Policlinico Tor Vergata Roma, Italy, 00133 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O. di Perugia Perugia, Italy, 06129 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. di Cagliari Cagliari, Italy, 09124 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ALM Oftalmolaser - Oftalmologia Medica e Cirurgica Lisbon, Portugal, 1050-078 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Hospitalar Universitario do Porto Porto, Portugal, 4099-001 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultna nemocnica s poliklinikou Zilina Zilina, Slovakia, 012 07 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultna nemocnica Nitra Nitra, Slovakia, 950 01 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nemocnica s Poliklinikou Trebisov, Svet zdravia a.s. Trebisov, Slovakia, 075 01 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Yamanashi Hospital Chuo, Japan, 409-3898 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kanazawa Medical University Hospital Kahoku-gun, Japan, 920-0293 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Otakeganka Tsukimino Clinic Yamato, Japan, 242-0001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kagawa University Hospital Kita-gun, Japan, 761-0793 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma, Italy, 00168 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASST Fatebenefratelli Sacco Milano, Italy, 20157 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nara Medical University Hospital Kashihara, Japan, 634-8522 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tokushima University Hospital Tokushima, Japan, 770-8503 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gunma University Hospital Maebashi, Japan, 371-8511 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medical corporation Eiwakai Dannoue Ophthalmology clinic Kawasaki, Japan, 211-0053 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tokiwadai Muranaka Eye Clinic Itabashi-ku, Japan, 174-0071 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kurashiki Medical Center Kurashiki, Japan, 710-8522 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kepler Universitätsklinikum Campus III Linz, Austria, 4020 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 8036 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Reina Sofía Córdoba, Spain, 14004 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Miguel Servet Zaragoza, Spain, 50009 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital General Universitario de Valencia Valencia, Spain, 46014 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Instituto Oftalmológico Francisco Gomez Ulla Santiago de Compostela, Spain, 15706 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitari i Politècnic La Fe Valencia, Spain, 46026 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Meir Medical Center Kfar Saba, Israel, 4428164 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chaim Sheba Medical Center Ramat Gan, Israel, 5262000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Assuta Medical Centers - HaShalom Tel Aviv, Israel, 6789140 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lady Davis Carmel Medical Center Haifa, Israel, 3436212 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Rambam Health Corporation Haifa, Israel, 3109601 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kaplan Medical Center Rehovot, Israel, 7610001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hadassah Hebrew University Hospital Ein Kerem Jerusalem, Israel, 9112001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations RétinElysée Lausanne, Switzerland, 1006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Berner Augenklinik am Lindenhofspital Bern, Switzerland, TBC | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Inje University Haeundae Paik Hospital Busan, South Korea, 612-862 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Center Nune Eye Hospital Seoul, South Korea, 135-280 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SEHAT Pentagram Sofia, Bulgaria, 1309 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sveta Petka Eye Hospital Varna, Bulgaria, 9002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiprofile Hospital for Active Treatment Sveta Sofia | Internal Diseases Department Sofia, Bulgaria, 1618 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UMHAT Alexandrovska EAD Sofia, Bulgaria, 1431 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Specialized Hospital For Active Treatment of Eye Diseases Zora Sofia, Bulgaria, 1784 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Spec. Hosp. for Active Treatment for Eye Diseases Zrenie Sofia, Bulgaria, 1408 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St.Joseph's Health Care-London London, Canada, N6A 4V2 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Toronto Retina Institute Toronto, Canada, M3C 0G9 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut de l'Oeil des Laurentides Boisbriand, Canada, J7H1S6 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Scientific Research Institution of Ophthalmic Diseases Moscow, Russia, 119021 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Southern Tohoku Eye Clinic Koriyama, Japan, 963-8052 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical hospital center Zvezdara Belgrade, Serbia, 11000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Center of Serbia Belgrade, Serbia, 11000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinicki centar Vojvodine Novi Sad, Serbia, 21000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St.Luke's International Hospital Chuoku, Japan, 104-8560 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LTD "Innova" Tbilisi, Georgia, 105 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LTD "Chichua Medical Center MZERA" Tbilisi, Georgia, 114 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations JSC "Evex Hospitals' Tbilisi, Georgia, 0186 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LTD "Clinic LJ" Kutaisi, Georgia, 4600 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tokyo Women's Medical University Hospital Shinjuku-ku, Japan, 162-8666 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Yamagata University Hospital Yamagata, Japan, 990-9585 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sapporo City General Hospital Sapporo, Japan, 060-8604 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nishikasai Inouye Eye Hospital Edogawa-ku, Japan, 134-0088 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shanghai General Hospital Shanghai, China, 200080 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations TianJin eye hospital Tianjin, China | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Affiliated Eye Hospital of Wenzhou Medical College Wenzhou, China | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Peking University People's Hospital Beijing, China, 100044 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tianjin Medical University Eye Hospital Tianjin, China, 300384 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Consultants of Southern Colorado, PC Colorado Springs, United States, 80909 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Wolfe Eye Clinic, PC West Des Moines, United States, 50266 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations OFTALMOS, Instituto Oftalmologico de Alta Complejidad Buenos Aires, Argentina, C1120AAN | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tokyo Medical University Hachioji Medical Center Hachioji, Japan, 193-0998 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations KKR Sapporo Medical Center Sapporo, Japan, 062-0931 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Espaco Medico de Coimbra Coimbra, Portugal, 3000-548 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Marianna University Hospital Kawasaki, Japan, 216-8511 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Guangzhou Aier Eye Hospital Guangzhou, China, 634050 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre d'Ophtalmologie - Paradis-Monticelli MARSEILLE, France, 13008 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre ophtalmologique Saint-Exupéry Saint-Cyr-Sur-Loire, France, 37540 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Private enterprise private production company " Acinus" Kropyvnytskyi, Ukraine, 25006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Union Hospt Tongji Medical Colleg. Huazhong univ. Scien&Tech Wuhan, China, 430030 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Henan Provincial Ophthalmology Hospital (Henan Eye Institute Zhengzhou, China, 450003 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The First Affiliated Hospital of Xinjiang Medical University Urumqi, China, 830054 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Beijing Hospital Beijing, China, 100730 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eye Center of the second Bethune Hospital, jinlin University Changchun, China, 130022 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tianjin Medical University General Hospital Tianjin, China, 300052 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The People's Hospital of Ningxia Hui Autonomous Region Yinchuan, China, 750000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Beijing Aier Intech Eye Hospital Co. LTD - Ophthalmology Beijing, China, 100021 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aier Eye Hospital (Chengdu) Chengdu, China, N/A | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SHENYANG HE EYE HOSPITAL Shenyang, China, 110034 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ZheJiang Provincial People's Hospital Hangzhou, China, 310014 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The 1st Affiliated Hospital of Zhejiang University Hangzhou, China, 310000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The 1st Affiliated Hospital Fujian Medical University Fuzhou, China, TBC | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chongqing Aier Ophthalmology Hospital Chongqing, China, 400020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Beijing Tongren Hospital, Capital Medical University (East) Beijing, China, 100005 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Second Hospital of Anhui medical university Hefei, China, 230601 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The First People's Hospital of Xuzhou Xuzhou, China, 221002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hebei Eye Hospital Xingtai, China | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jiangxi Provincial People’s Hospital Nanchang, China, 330006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The First Affiliated Hospital of NanChang University Nanchang, China, 330006 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shanghai Tongji Hospital of Tongji University Shanghai, China, TBC | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tonghua Central Hospital Tonghua, China, 134001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shijiazhuang General Hospital Shijiazhuang, China, 050000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Lariboisière - Paris PARIS, France, 75475 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Budapest Retina Associates Budapest, Hungary, 1133 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Rand Eye Institute Deerfield Beach, United States, 33064 | 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 from baseline in BCVA measured by the ETDRS letter score at Week 48Timeframe: At baseline and Week 48
Secondary Outcome
- Change from baseline in BCVA measured by the ETDRS letter score at Week 60Timeframe: At baseline and Week 60
- Proportion of participants with no intraretinal fluid (IRF) and no subretinal fluid (SRF) in central subfield at Week 16Timeframe: At Week 16
- Proportion of participants gaining at least 15 letters in BCVA from baseline at Week 48Timeframe: At baseline and Week 48
- Proportion of participants achieving an ETDRS letter score of at least 69 (approximate 20/40 Snellen equivalent) at Week 48Timeframe: At Week 48
- Change in choroidal neovascularization (CNV) size from baseline to Week 48Timeframe: At baseline and Week 48
- Change in total lesion area from baseline to Week 48Timeframe: At baseline and Week 48
- Proportion of participants with no IRF and no SRF in the center subfield at Week 48Timeframe: At Week 48
- Change from baseline in central subfield retinal thickness (CST) at Week 48Timeframe: At baseline and Week 48
- Change from baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) total score at Week 48NEI VFQ-25 was a 25-item questionnaire that gave a score on a scale from 0 (worst) to 100 (best = no vision problems)Timeframe: At baseline and Week 48
- Number of participants with treatment-emergent adverse events (TEAEs) and serious AEs (SAEs)Timeframe: Up to 156 weeks
- Systemic exposure to aflibercept as assessed by plasma concentrations of free, adjusted bound and total aflibercept from baseline through Week 48Timeframe: Up to Week 48
- Assessment of immunogenicity to aflibercept by measuring the incidence of treatment-emergent anti-drug antibodies (ADA) response through end of masked studyTimeframe: Up to week 96
Additional Information
Copyright © Bayer
Powered by
