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Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 in Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

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研究单位: [1]Quark Pharmaceuticals [2]University of Arkansas Medical Center, Jones Eye Institute,Little Rock,Arkansas,United States,72205 [3]Loma Linda University Eye Institute,Loma Linda,California,United States,92354 [4]University of Southern California,Los Angeles,California,United States,90033 [5]NeuroEyeOrbit Institute,Los Angeles,California,United States,90048 [6]Stanford University,Palo Alto,California,United States,94303 [7]Unversity of California, Los Angeles (UCLA),Pasadena,California,United States,91105 [8]Tan Tock Seng Hospital, Department of Ophthalmology,Singapore,Singapore,308433 [9]University of Colorado Denver, Department of Neurology,Aurora,Colorado,United States,80045 [10]Retina Consultants of Southern Colorado, PC,Colorado Springs,Colorado,United States,80909 [11]The Eye Care Group,Waterbury,Connecticut,United States,06708 [12]Cape Coral Eye Center,Cape Coral,Florida,United States,33904 [13]University of Miami Miller School of Medicine/Bascom Palmer Eye Institute,Miami,Florida,United States,33136 [14]Sarasota Retina Institute,Sarasota,Florida,United States,34239 [15]Northwestern University,Chicago,Illinois,United States,60611 [16]University of Illinois at Chicago, Department of Ophthalmology (MC 648),Chicago,Illinois,United States,60612 [17]NorthShore University Healthsystem,Glenview,Illinois,United States,60026 [18]University of Kentucky, Department of Neurology,Lexington,Kentucky,United States,40536 [19]Greater Baltimore Medical Center,Baltimore,Maryland,United States,21204 [20]Bethesda Neurology, LLC,Bethesda,Maryland,United States,20852 [21]Massachusetts Eye and Ear Infirmary,Boston,Massachusetts,United States,02114 [22]Boston Medical Center,Boston,Massachusetts,United States,21118 [23]University of Michigan,Ann Arbor,Michigan,United States,48105 [24]University of Minnesota,Minneapolis,Minnesota,United States,55455 [25]Mayo Clinic,Rochester,Minnesota,United States,55905 [26]Washington University in St. Louis,Saint Louis,Missouri,United States,63110 [27]University of Nebraska Medical Center and Truhlsen Eye Institute,Omaha,Nebraska,United States,68198 [28]Rutgers, New Jersey Medical School,Newark,New Jersey,United States,07103 [29]New York Eye and Ear Infirmary of Mount Sinai,New York,New York,United States,10003 [30]Cornell University School of Medicine,New York,New York,United States,10583 [31]University of Rochester, Flaum Eye Institute,Rochester,New York,United States,14642 [32]State University of New York at Stony Brook,Stony Brook,New York,United States,11794 [33]SUNY Upstate Medical University,Syracuse,New York,United States,13210 [34]Duke University Eye Center,Durham,North Carolina,United States,27705 [35]Raleigh Neurology Associates,Raleigh,North Carolina,United States,27607 [36]Cleveland Clinic, Cole Eye Institute,Cleveland,Ohio,United States,44195 [37]Dean McGee Eye Institute,Oklahoma City,Oklahoma,United States,73013 [38]University of Pennsylvania, Scheie Eye Institute,Philadelphia,Pennsylvania,United States,19104 [39]Retina Consultants of Charleston,Charleston,South Carolina,United States,29414 [40]University of Houston, Neuro-Ophth of Texas,Houston,Texas,United States,77025 [41]Houston Methodist Hospital, Blanton Eye Institute,Houston,Texas,United States,77030 [42]Foresight Studies,San Antonio,Texas,United States,78240 [43]University of Utah John A. Moran Eye Center,Salt Lake City,Utah,United States,84132 [44]University of Virginia Health Sciences Center,Charlottesville,Virginia,United States,22908 [45]Swedish Medical Center, CO/NOCNW,Seattle,Washington,United States,98104 [46]University of Washington Department of Ophthalmology,Seattle,Washington,United States,98104 [47]Sydney Eye Hospital/Save Sight Institute,Sydney,New South Wales,Australia,2000 [48]Vision South Australia,Kent Town,South Australia,Australia,5267 [49]The Royal Victorian Eye and Ear Hospital,Fitzroy,Victoria,Australia,3002 [50]Royal Perth Hospital,Perth,Western Australia,Australia,6000 [51]The Second Xiangya Hospital of Central South University,Changsha,Hunan,China,410013 [52]Peking University Eye Center, The Third Hospital Peking University.,Beijing,China,100191 [53]Beijing Tongren Hospital, Capital Medical University,Beijing,China,100730 [54]Peking Union Medical College Hospital,Beijing,China,100730 [55]Tianjin Eye Hospital,Tianjin,China,300000 [56]Universitätsmedizin d. Johannes Gutenberg-Universität Mainz,Mainz,Rheinland-Pfalz,Germany,55131 [57]Universitätsklinikum Aachen-Augenklinik,Aachen,Germany,52074 [58]Universitätsklinikum Carl Gustav Carus-Dresden-Klinik und Poliklinik für Augenheilkunde,Dresden,Germany,01307 [59]Universitätsklinikum Münster,Münster,Germany,48149 [60]Universitätsklinikum Regensburg-Klinik und Poliklinik für Augenheilkunde,Regensburg,Germany,93053 [61]Universitäts-Augenklinik Tübingen,Tubingen,Germany,72076 [62]L V Prasad Eye Institute,Hyderabad,Andhra Pradesh,India,500034 [63]L V Prasad Eye Institute,Visakhapatnam,Andhra Pradesh,India,530040 [64]Sri Sankaradeva Nethralaya,Guwahati,Assam,India,781028 [65]Narayana Nethralaya,Bangalore,Karnataka,,India,560010 [66]PBMA'S H. V. Desai Eye Hospital,Pune,Maharashtra,India,411060 [67]L V Prasad Eye Institute,Bhubaneswar,Orissa,India,751024 [68]Sankara Nethralaya (Vision Research Foundation),Chennai,Tami Nadu,India,600006 [69]Aravind Eye Hospital,Madurai,Tamil Nadu,India,625020 [70]Sanjay Gandhi Postgraduate Institute of Medical Sciences,Lucknow,Uttar Pradesh,India,226014 [71]ICARE Research Centre and Post Graduate Institute,Noida,Uttar Pradesh,India,201301 [72]Dr. Rajendra Prasad Centre for Ophthalmic Sciences, A.I.I.M.S.,New Delhi,India,110029 [73]Datta Meghe Institute of Medical Sciences,Wardha,India,442005 [74]Hadassah Medical Center,Jerusalem,Yerushalayim,Israel,9112001 [75]Soroka University Medical Center,Beer-Sheva,Israel,84101 [76]Bnai Zion Medical Center,Haifa,Israel,31048 [77]Rabin Medical Center, Belinson Campus,Petach-Tikva,Israel,49100 [78]Kaplan Medical Center,Rehovot,Israel,76100 [79]The Tel-Aviv Sourasky Medical Center,Tel-Aviv,Israel,64239 [80]The Chaim Sheba Medical Center,Tel-Hashomer,Israel,52621 [81]AOU Policlinico S. Orsola-Malpighi,Bologna,Italy,40139 [82]AOU Careggi,Firenze,Italy,50134 [83]Scientific Institute Auxologico Italiano,Milano,Italy [84]Scientific institute San Raffaele,Milano,Italy [85]University Eye Clinic,Parma,Italy,43100 [86]Singapore National Eye Centre,Singapore,Singapore,168751

关键词: NAION

研究目的:
This study will determine the effect of QPI-1007 on visual function in subjects with recent-onset NAION and assess the safety and tolerability of intravitreal injections of QPI-1007 in this population. This study will also evaluate the structural changes in the retina following administration of QPI-1007.

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