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:

NCT04423718

EudraCT Number:

2019-003851-12

EU CT Number:

Not Available

Recruitment Complete

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
1011
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Aflibercept (VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
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Kobe University Hospital

Kobe, Japan, 650-0017

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Hyogo Prefectural Amagasaki General Medical Center

Amagasaki, Japan, 660-8550

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Nagoya City University Hospital

Nagoya, Japan, 467-8602

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University of the Ryukyus Hospital

Nakagami, Japan, 903-0215

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AXON Clinical s.r.o.

Praha 5, Czech Republic, 150 00

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Fakultni nemocnice Ostrava

Ostrava, Czech Republic, 708 52

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Fakultni Nemocnice Hradec Kralove

Hradec Kralove, Czech Republic, 500 05

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Charles University in Prague

Prague, Czech Republic, 110 00

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Sydney Retina Clinic

Sydney, Australia, 2000

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Marsden Eye Surgery Center

Parramatta, Australia, 2150

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Westmead Hospital

Westmead, Australia, 2145

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Eyeclinic Albury Wodonga

Albury, Australia, 2640

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Hobart Eye Surgeons

Hobart, Australia, 7000

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Klinikum Klagenfurt am Wörthersee

Klagenfurt, Austria, 9020

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Pusan National University Hospital

Busan, South Korea, 49241

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Asan Medical Center

Seoul, South Korea, 138-736

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Samsung Medical Center

Seoul, South Korea, 6351

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Seoul National University Hospital

Seoul, South Korea, 03080

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Seoul National University Bundang Hospital

Seongnam-si, South Korea, 13620

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New England Retina Associates

New London, United States, 06320

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Ophthalmic Consultants of Boston

Boston, United States, 02114

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Palmetto Retina Center, LLC

West Columbia, United States, 29169

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Medical Center Ophthalmology Associates

San Antonio, United States, 78240

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Hayashi Eye Hospital

Fukuoka, Japan, 812-0011

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Daiyukai Daiichi Hospital

Ichinomiya, Japan, 491-8551

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National Hospital Organization Tokyo Medical Center

Meguro-ku, Japan, 152-8902

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Fakultna nemocnica Trencin

Trencin, Slovakia, 911 71

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Stadtspital Triemli

Zürich, Switzerland, 8063

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Chang Gung Memorial Hospital at Linkou

Taoyuan, Taiwan, China, 33305

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Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan, China, 111

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National University Hospital

Singapore, Singapore, 119074

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Organizacion Medica de Investigacion (OMI)

Buenos Aires, Argentina, C1015ABO

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Konventhospital Barmherzige Brüder Linz

Linz, Austria, 4021

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Hanusch-Krankenhaus Wien

Wien, Austria, 1140

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Mie University Hospital

Tsu, Japan, 514-8507

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Akita University Hospital

Akita, Japan, 010-8543

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Nagoya University Hospital

Nagoya, Japan, 466-8560

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Kansai Medical University Hospital

Hirakata, Japan, 573-1191

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Hiroshima University Hospital

Hiroshima, Japan, 734-8551

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AIBILI

Coimbra, Portugal, 3000-548

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Oita University Hospital

Yufu, Japan, 879-5593

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Taipei Veterans General Hospital

Taipei, Taiwan, China, 11217

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Fukushima Medical University Hospital

Fukushima, Japan, 960-1295

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Okayama University Hospital

Okayama, Japan, 700-8558

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Kurume University Hospital

Kurume, Japan, 830-0011

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Yamaguchi University Hospital

Ube, Japan, 755-8505

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Kanazawa University Hospital

Kanazawa, Japan, 920-8641

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Fakultni nemocnice Kralovske Vinohrady

Praha 10, Czech Republic, 10034

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Hospital of LT University of Health Sciences Kaunas Clinics

Kaunas, Lithuania, LT-50161

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Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania, LT-08661

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PI Klaipedos University Hospital

Klaipeda, Lithuania, LT-92288

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East Tallinn Central Hospital

Tallinn, Estonia, 10138

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Latvian American Eye Center

Riga, Latvia, LV-1009

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Department of Ophthalmology

Riga, Latvia, 1002

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Long Island Vitreoretinal Consultants

Great Neck, United States, 11021

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Ophthalmic Consultants of Long Island

Lynbrook, United States, 11563

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Long Island Vitreoretinal Consultants - Hauppauge

Hauppauge, United States, 11788

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NJ Retina

Edison, United States, 08820

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Texas Retina Associates

Fort Worth, United States, 76104

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Retina Northwest, PC

Portland, United States, 97210

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Retina Care Center

Baltimore, United States, 21209

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Retina Consultants of Nevada

Las Vegas, United States, 89144

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Retina Center of New Jersey

Bloomfield, United States, 07003

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Retina Vitreous Associates of Florida - Saint Petersburg

Saint Petersburg, United States, 33711-1141

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West Virginia University

Morgantown, United States, 26505

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Spokane Eye Clinical Research

Spokane, United States, 99204

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Arizona Retina and Vitreous Consultants - Research

Phoenix, United States, 85021

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Florida Retina Institute

Jacksonville, United States, 32204

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California Eye Specialists

Pasadena, United States, 91107

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Retinal Consultants of Texas - San Antonio

San Antonio, United States, 78240

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Mid Atlantic Retina

Bethlehem, United States, 18017

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Retina Consultants of Texas - The Woodlands

The Woodlands, United States, 77384

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Charles Retina Institute

Memphis, United States, 38119

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Retina Consultants of Houston

The Woodlands, United States, 77384

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Vitreo Retinal Surgery PA

Edina, United States, 55435

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Retina Consultants San Diego

Poway, United States, 92064

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University Retina and Macula Associates

Oak Forest, United States, 60452

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Florida Retina Institute

Orlando, United States, 32806

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Southern Vitreoretinal Associates

Tallahassee, United States, 32308

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Vitreo-Retinal Associates

Gainesville, United States, 32607

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Retina Group of Florida

Ft. Lauderdale, United States, 33308

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Vanderbilt University Medical School

Nashville, United States, 37232

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Eye Associates of New Mexico

Albuquerque, United States, 87109-5853

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Black Hills Regional Eye Institute

Rapid City, United States, 57701-7374

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Eye Care Specialists

Kingston, United States, 18704

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Northern California Retina-Vitreous Associates

Mountain View, United States, 94040

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Charleston Neuroscience Center

Charleston, United States, 29414

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Retina Macula Specialists of Miami

Miami, United States, 33126

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Midwest Retina - Main Office

Dublin, United States, 43016

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Retina Consultants of Hawaii

Aiea, United States, 96701

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Fletcher Allen Health Care

Burlington, United States, 05401-1420

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Retina Associates IL

Elmhurst, United States, 60126

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Florida Eye Associates

Melbourne, United States, 32901

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Erie Retinal Surgery, Inc.

Erie, United States, 16507

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Austin Retina Associates

Austin, United States, 78705

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Retina Consultants of Southern California

Redlands, United States, 92374

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University of Wisconsin - Madison

Madison, United States, 53792

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Wake Forest Baptist Health

Winston-Salem, United States, 27103

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University of California San Diego

La Jolla, United States, 92093-0698

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Retina Specialists

Pensacola, United States, 32503

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Retina Consultants of Orange County

Fullerton, United States, 92835

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Ophthalmic Consultants of the Capital Region

Troy, United States, 12180

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Retina Consultants, LLC

Salem, United States, 97302-2152

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Kaiser Permanente Riverside Medical Center

Riverside, United States, 92505

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Kozawa Eye Hospital and Diabetes Center

Mito, Japan, 310-0845

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The University of Tokyo Hospital

Bunkyo-ku, Japan, 113-8655

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Kansai Medical University Medical Center

Moriguchi, Japan, 570-8507

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Kindai University Hospital

Osakasayama, Japan, 589-8511

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Aichi Medical University Hospital

Nagakute, Japan, 480-1195

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Lexum a.s., Evropska ocni klinika

Praha 4, Czech Republic, 140 00

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Fakultni nemocnice Plzen - Lochotin

Plzen-Lochotin, Czech Republic, 323 00

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Szent-Gyorgyi Albert Orvostudomanyi Egyetem

Szeged, Hungary, 6720

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Tartu University Hospital

Tartu, Estonia

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Riga East Clinical University Hospital "Gailezers"

Riga, Latvia, LV-1006

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Shinshu University Hospital

Matsumoto, Japan, 390-8621

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Japanese Red Cross Saitama Hospital

Saitama, Japan, 330-8553

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Kokura Memorial Hospital

Kitakyushu, Japan, 802-8555

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Japanese Red Cross Nagasaki Genbaku Hospital

Nagasaki, Japan, 852-8511

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Japanese Red Cross Wakayama Medical center

Wakayama, Japan, 640-8558

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Singapore National Eye Centre

Singapore, Singapore, 168751

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University of Miyazaki Hospital

Miyazaki, Japan, 889-1692

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Keio University Hospital

Shinjuku-ku, Japan, 160-8582

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Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi

Poltava, Ukraine, 36011

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Centralna Polyclinica MVS Ukraiiny

Kyiv, Ukraine, 01024

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Ospedale San Raffaele s.r.l.

Milano, Italy, 20132

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Fondazione PTV Policlinico Tor Vergata

Roma, Italy, 00133

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IRCCS Fondazione G.B. Bietti Studio e Ricerca in Otalmologia

Roma, Italy, 00198

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A.O. di Perugia

Perugia, Italy, 06129

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A.O.U. di Cagliari

Cagliari, Italy, 09124

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ALM Oftalmolaser - Oftalmologia Medica e Cirurgica

Lisbon, Portugal, 1050-078

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Centro Hospitalar Universitario do Porto

Porto, Portugal, 4099-001

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Centro Hospitalar Vila Nova de Gaia/Espinho | Unit 1 - Clinical Research Office

Porto, Portugal, 4434-502

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Fakultna nemocnica s poliklinikou Zilina

Zilina, Slovakia, 012 07

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Fakultna nemocnica Nitra

Nitra, Slovakia, 950 01

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Nemocnica s Poliklinikou Trebisov, Svet zdravia a.s.

Trebisov, Slovakia, 075 01

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University of Yamanashi Hospital

Chuo, Japan, 409-3898

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Kanazawa Medical University Hospital

Kahoku-gun, Japan, 920-0293

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Otakeganka Tsukimino Clinic

Yamato, Japan, 242-0001

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Kagawa University Hospital

Kita-gun, Japan, 761-0793

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy, 00168

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ASST Fatebenefratelli Sacco

Milano, Italy, 20157

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Nara Medical University Hospital

Kashihara, Japan, 634-8522

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Tokushima University Hospital

Tokushima, Japan, 770-8503

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Gunma University Hospital

Maebashi, Japan, 371-8511

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Medical corporation Eiwakai Dannoue Ophthalmology clinic

Kawasaki, Japan, 211-0053

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Tokiwadai Muranaka Eye Clinic

Itabashi-ku, Japan, 174-0071

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Kurashiki Medical Center

Kurashiki, Japan, 710-8522

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Medizinische Universität Graz

Graz, Austria, 8036

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Kepler Universitätsklinikum Campus III

Linz, Austria, 4020

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Hospital de la Santa Creu i Sant Pau | Gynecology Department

Barcelona, Spain, 8041

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Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 8036

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Hospital Reina Sofía

Córdoba, Spain, 14004

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Hospital Miguel Servet

Zaragoza, Spain, 50009

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Hospital General Universitario de Valencia

Valencia, Spain, 46014

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Instituto Oftalmológico Francisco Gomez Ulla

Santiago de Compostela, Spain, 15706

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Hospital Universitari i Politècnic La Fe

Valencia, Spain, 46026

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Meir Medical Center

Kfar Saba, Israel, 4428164

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Chaim Sheba Medical Center

Ramat Gan, Israel, 5262000

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Assuta Medical Centers - HaShalom

Tel Aviv, Israel, 6789140

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Lady Davis Carmel Medical Center

Haifa, Israel, 3436212

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Rambam Health Corporation

Haifa, Israel, 3109601

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Kaplan Medical Center

Rehovot, Israel, 7610001

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Hadassah Hebrew University Hospital Ein Kerem

Jerusalem, Israel, 9112001

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RétinElysée

Lausanne, Switzerland, 1006

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Berner Augenklinik am Lindenhofspital

Bern, Switzerland, TBC

Locations

Inje University Haeundae Paik Hospital

Busan, South Korea, 612-862

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Retina Center Nune Eye Hospital

Seoul, South Korea, 135-280

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SEHAT Pentagram

Sofia, Bulgaria, 1309

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Sveta Petka Eye Hospital

Varna, Bulgaria, 9002

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Multiprofile Hospital for Active Treatment Sveta Sofia | Internal Diseases Department

Sofia, Bulgaria, 1618

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UMHAT Alexandrovska EAD

Sofia, Bulgaria, 1431

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Specialized Hospital For Active Treatment of Eye Diseases Zora

Sofia, Bulgaria, 1784

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Spec. Hosp. for Active Treatment for Eye Diseases Zrenie

Sofia, Bulgaria, 1408

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St.Joseph's Health Care-London

London, Canada, N6A 4V2

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Toronto Retina Institute

Toronto, Canada, M3C 0G9

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Institut de l'Oeil des Laurentides

Boisbriand, Canada, J7H1S6

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Scientific Research Institution of Ophthalmic Diseases

Moscow, Russia, 119021

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FBSI IRTC Eye Microsurgery n.a. acad. S.N. Fyodorov

Moscow, Russia, 127486

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Southern Tohoku Eye Clinic

Koriyama, Japan, 963-8052

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Clinical hospital center Zvezdara

Belgrade, Serbia, 11000

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Clinical Center of Serbia

Belgrade, Serbia, 11000

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Klinicki centar Vojvodine

Novi Sad, Serbia, 21000

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St.Luke's International Hospital

Chuoku, Japan, 104-8560

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LTD "Innova"

Tbilisi, Georgia, 105

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LTD "Chichua Medical Center MZERA"

Tbilisi, Georgia, 114

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JSC "Evex Hospitals'

Tbilisi, Georgia, 0186

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LTD "Clinic LJ"

Kutaisi, Georgia, 4600

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Tokyo Women's Medical University Hospital

Shinjuku-ku, Japan, 162-8666

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Yamagata University Hospital

Yamagata, Japan, 990-9585

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Sapporo City General Hospital

Sapporo, Japan, 060-8604

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Nishikasai Inouye Eye Hospital

Edogawa-ku, Japan, 134-0088

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Shanghai General Hospital

Shanghai, China, 200080

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TianJin eye hospital

Tianjin, China

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The Affiliated Eye Hospital of Wenzhou Medical College

Wenzhou, China

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Peking University People's Hospital

Beijing, China, 100044

Locations

Tianjin Medical University Eye Hospital

Tianjin, China, 300384

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Retina Consultants of Southern Colorado, PC

Colorado Springs, United States, 80909

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Wolfe Eye Clinic, PC

West Des Moines, United States, 50266

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OFTALMOS, Instituto Oftalmologico de Alta Complejidad

Buenos Aires, Argentina, C1120AAN

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Tokyo Medical University Hachioji Medical Center

Hachioji, Japan, 193-0998

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KKR Sapporo Medical Center

Sapporo, Japan, 062-0931

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Espaco Medico de Coimbra

Coimbra, Portugal, 3000-548

Locations

St. Marianna University Hospital

Kawasaki, Japan, 216-8511

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Guangzhou Aier Eye Hospital

Guangzhou, China,  634050

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Centre d'Ophtalmologie - Paradis-Monticelli

MARSEILLE, France, 13008

Locations

Centre ophtalmologique Saint-Exupéry

Saint-Cyr-Sur-Loire, France, 37540

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Private enterprise private production company " Acinus"

Kropyvnytskyi, Ukraine, 25006

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Union Hospt Tongji Medical Colleg. Huazhong univ. Scien&Tech

Wuhan, China, 430030

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Henan Provincial Ophthalmology Hospital (Henan Eye Institute

Zhengzhou, China, 450003

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The First Affiliated Hospital of Xinjiang Medical University

Urumqi, China, 830054

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Beijing Hospital

Beijing, China, 100730

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Eye Center of the second Bethune Hospital, jinlin University

Changchun, China, 130022

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Tianjin Medical University General Hospital

Tianjin, China, 300052

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Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.

Wuhan, China, 430030

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The People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, China, 750000

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Beijing Aier Intech Eye Hospital Co. LTD - Ophthalmology

Beijing, China, 100021

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Aier Eye Hospital (Chengdu)

Chengdu, China, N/A

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SHENYANG HE EYE HOSPITAL

Shenyang, China, 110034

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ZheJiang Provincial People's Hospital

Hangzhou, China, 310014

Locations

The 1st Affiliated Hospital of Zhejiang University

Hangzhou, China, 310000

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The 1st Affiliated Hospital Fujian Medical University

Fuzhou, China, TBC

Locations

Chongqing Aier Ophthalmology Hospital

Chongqing, China, 400020

Locations

Beijing Tongren Hospital, Capital Medical University (East)

Beijing, China, 100005

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The Second Hospital of Anhui medical university

Hefei, China, 230601

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The First People's Hospital of Xuzhou

Xuzhou, China, 221002

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Hebei Eye Hospital

Xingtai, China

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Jiangxi Provincial People’s Hospital

Nanchang, China, 330006

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The First Affiliated Hospital of NanChang University

Nanchang, China, 330006

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The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China, 710061

Locations

Shanghai Tongji Hospital of Tongji University

Shanghai, China, TBC

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Tonghua Central Hospital

Tonghua, China, 134001

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Shijiazhuang General Hospital

Shijiazhuang, China, 050000

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Hôpital Lariboisière - Paris

PARIS, France, 75475

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Budapest Retina Associates

Budapest, Hungary, 1133

Locations

Rand Eye Institute

Deerfield Beach, United States, 33064

Trial Design