Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 in Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
NCT ID: NCT02341560
Last Updated: 2020-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
732 participants
INTERVENTIONAL
2016-02-24
2019-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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single dose or multiple dose
QPI-1007 Injection - 1.5 mg
QPI-1007 Injection - 1.5 mg
single or multiple dose
QPI-1007 Injection - 3.0 mg
QPI-1007 Injection - 3.0 mg
Sham
Sham injection procedure
Sham Injection Procedure
Sham Procedure
Interventions
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QPI-1007 Injection - 1.5 mg
QPI-1007 Injection - 3.0 mg
Sham Injection Procedure
Sham Procedure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Best corrected visual acuity score in the study eye is better than or equal to 15 letter score, measured using the ETDRS visual acuity protocol at Day 1 prior to study drug administration/sham procedure.
* Clear ocular media and able to undergo adequate pupil dilation to allow a good fundus examination
Exclusion Criteria
* Prior episode of NAION in the study eye only
* Present use of drugs known to cause optic nerve or retinal toxicity at Day 1/Randomization, such as: chloroquine or hydroxychloroquine, ethambutol, Vigabatrin. Subjects who need to be prescribed any of these drugs during the course of the study will be discontinued from the trial.
* Any medical condition, concomitant therapy, or previous incisional or laser surgery that, in the opinion of the Investigator, would preclude IVT injection in the study eye only
* Clinical evidence of temporal arteritis
50 Years
80 Years
ALL
No
Sponsors
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Quark Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Sharon Klier, M.D.
Role: STUDY_DIRECTOR
Quark Pharmaceuticals
Locations
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University of Arkansas Medical Center, Jones Eye Institute
Little Rock, Arkansas, United States
Loma Linda University Eye Institute
Loma Linda, California, United States
University of Southern California
Los Angeles, California, United States
NeuroEyeOrbit Institute
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
Unversity of California, Los Angeles (UCLA)
Pasadena, California, United States
University of Colorado Denver, Department of Neurology
Aurora, Colorado, United States
Retina Consultants of Southern Colorado, PC
Colorado Springs, Colorado, United States
The Eye Care Group
Waterbury, Connecticut, United States
Cape Coral Eye Center
Cape Coral, Florida, United States
University of Miami Miller School of Medicine/Bascom Palmer Eye Institute
Miami, Florida, United States
Sarasota Retina Institute
Sarasota, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Illinois at Chicago, Department of Ophthalmology (MC 648)
Chicago, Illinois, United States
NorthShore University Healthsystem
Glenview, Illinois, United States
University of Kentucky, Department of Neurology
Lexington, Kentucky, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Bethesda Neurology, LLC
Bethesda, Maryland, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University in St. Louis
St Louis, Missouri, United States
University of Nebraska Medical Center and Truhlsen Eye Institute
Omaha, Nebraska, United States
Rutgers, New Jersey Medical School
Newark, New Jersey, United States
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, United States
Cornell University School of Medicine
New York, New York, United States
University of Rochester, Flaum Eye Institute
Rochester, New York, United States
State University of New York at Stony Brook
Stony Brook, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Duke University Eye Center
Durham, North Carolina, United States
Raleigh Neurology Associates
Raleigh, North Carolina, United States
Cleveland Clinic, Cole Eye Institute
Cleveland, Ohio, United States
Dean McGee Eye Institute
Oklahoma City, Oklahoma, United States
University of Pennsylvania, Scheie Eye Institute
Philadelphia, Pennsylvania, United States
Retina Consultants of Charleston
Charleston, South Carolina, United States
University of Houston, Neuro-Ophth of Texas
Houston, Texas, United States
Houston Methodist Hospital, Blanton Eye Institute
Houston, Texas, United States
Foresight Studies
San Antonio, Texas, United States
University of Utah John A. Moran Eye Center
Salt Lake City, Utah, United States
University of Virginia Health Sciences Center
Charlottesville, Virginia, United States
Swedish Medical Center, CO/NOCNW
Seattle, Washington, United States
University of Washington Department of Ophthalmology
Seattle, Washington, United States
Sydney Eye Hospital/Save Sight Institute
Sydney, New South Wales, Australia
Vision South Australia
Kent Town, South Australia, Australia
The Royal Victorian Eye and Ear Hospital
Fitzroy, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Peking University Eye Center, The Third Hospital Peking University.
Beijing, , China
Beijing Tongren Hospital, Capital Medical University
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
Tianjin Eye Hospital
Tianjin, , China
Universitätsmedizin d. Johannes Gutenberg-Universität Mainz
Mainz, Rhineland-Palatinate, Germany
Universitätsklinikum Aachen-Augenklinik
Aachen, , Germany
Universitätsklinikum Carl Gustav Carus-Dresden-Klinik und Poliklinik für Augenheilkunde
Dresden, , Germany
Universitätsklinikum Münster
Münster, , Germany
Universitätsklinikum Regensburg-Klinik und Poliklinik für Augenheilkunde
Regensburg, , Germany
Universitäts-Augenklinik Tübingen
Tübingen, , Germany
L V Prasad Eye Institute
Hyderabad, Andhra Pradesh, India
L V Prasad Eye Institute
Visakhapatnam, Andhra Pradesh, India
Sri Sankaradeva Nethralaya
Guwahati, Assam, India
Narayana Nethralaya
Bangalore, Karnataka, India
PBMA'S H. V. Desai Eye Hospital
Pune, Maharashtra, India
L V Prasad Eye Institute
Bhubaneswar, Odisha, India
Sankara Nethralaya (Vision Research Foundation)
Chennai, Tami Nadu, India
Aravind Eye Hospital
Madurai, Tamil Nadu, India
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, India
ICARE Research Centre and Post Graduate Institute
Noida, Uttar Pradesh, India
Dr. Rajendra Prasad Centre for Ophthalmic Sciences, A.I.I.M.S.
New Delhi, , India
Datta Meghe Institute of Medical Sciences
Wardha, , India
Hadassah Medical Center
Jerusalem, Jerusalem, Israel
Soroka University Medical Center
Beersheba, , Israel
Bnai Zion Medical Center
Haifa, , Israel
Rabin Medical Center, Belinson Campus
Petah Tikva, , Israel
Kaplan Medical Center
Rehovot, , Israel
The Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
The Chaim Sheba Medical Center
Tel Litwinsky, , Israel
AOU Policlinico S. Orsola-Malpighi
Bologna, , Italy
AOU Careggi
Florence, , Italy
Scientific Institute Auxologico Italiano
Milan, , Italy
Scientific institute San Raffaele
Milan, , Italy
University Eye Clinic
Parma, , Italy
Singapore National Eye Centre
Singapore, , Singapore
Tan Tock Seng Hospital, Department of Ophthalmology
Singapore, , Singapore
Countries
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References
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Davis JL. The Blunt End: Surgical Challenges of Gene Therapy for Inherited Retinal Diseases. Am J Ophthalmol. 2018 Dec;196:xxv-xxix. doi: 10.1016/j.ajo.2018.08.038. Epub 2018 Sep 5.
Other Identifiers
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QRK207
Identifier Type: -
Identifier Source: org_study_id
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