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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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ClinicalTrials.gov Identifier: NCT02341560
Recruitment Status : Terminated (An interim analysis did not warrant to continue enrollment)
First Posted : January 19, 2015
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Quark Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non Arteritic Anterior Ischemic Optic Neuropathy Drug: QPI-1007 Injection - 1.5 mg Drug: QPI-1007 Injection - 3.0 mg Other: Sham Injection Procedure Phase 2 Phase 3

Detailed Description:
This is a double masked, randomized, sham-controlled efficacy and safety study that will enroll approximately 800 subjects with recent-onset NAION. Subjects will be randomized into one of 3 groups in a 1:1:1 ratio, and assigned to receive QPI-1007 and/or a sham procedure. Subjects will have a two in three (66%) chance of receiving active treatment (no sham procedure) and a one in three (33%) chance of receiving sham procedure (no active treatment). Total study time involvement is approximately 12 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 732 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 Delivered By Single or Multi-Dose Intravitreal Injection(s) to Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
Actual Study Start Date : February 24, 2016
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 1, 2019


Arm Intervention/treatment
Active Comparator: single dose or multiple dose
QPI-1007 Injection - 1.5 mg
Drug: QPI-1007 Injection - 1.5 mg
Other Name: QPI-1007

Active Comparator: single or multiple dose
QPI-1007 Injection - 3.0 mg
Drug: QPI-1007 Injection - 3.0 mg
Other Name: QPI-1007

Sham Comparator: Sham
Sham injection procedure
Other: Sham Injection Procedure
Sham Procedure
Other Name: Sham




Primary Outcome Measures :
  1. Effect of QPI-1007 as assessed by Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline through Month 12 ]
  2. Safety and tolerability of QPI-1007 as assessed by adverse events (AE), laboratory evaluations, ECGs, ophthalmic evaluations, slit lamp anterior/posterior examinations, intraocular pressure measurements, presence/absence of vitreous inflammation [ Time Frame: Baseline through Month 12 ]

Secondary Outcome Measures :
  1. Mean change in BCVA score, as measured by ETDRS visual acuity protocol in the study eye [ Time Frame: Day 1 through Month 12 ]
  2. Mean change of Visual Fields, as assessed by Humphrey standard automated perimetry [ Time Frame: Day 1 through Month 12 ]


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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Positive diagnosis of first episode of NAION in the study eye with symptom onset within 14 days prior to planned study drug administration/sham procedure
  • 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

Key Exclusion Criteria:

  • Present use or history of any treatment for the current episode of NAION, including systemic steroids, brimonidine, or traditional Chinese herbal medicine
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341560


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Locations
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United States, Arkansas
University of Arkansas Medical Center, Jones Eye Institute
Little Rock, Arkansas, United States, 72205
United States, California
Loma Linda University Eye Institute
Loma Linda, California, United States, 92354
University of Southern California
Los Angeles, California, United States, 90033
NeuroEyeOrbit Institute
Los Angeles, California, United States, 90048
Stanford University
Palo Alto, California, United States, 94303
Unversity of California, Los Angeles (UCLA)
Pasadena, California, United States, 91105
United States, Colorado
University of Colorado Denver, Department of Neurology
Aurora, Colorado, United States, 80045
Retina Consultants of Southern Colorado, PC
Colorado Springs, Colorado, United States, 80909
United States, Connecticut
The Eye Care Group
Waterbury, Connecticut, United States, 06708
United States, Florida
Cape Coral Eye Center
Cape Coral, Florida, United States, 33904
University of Miami Miller School of Medicine/Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Sarasota Retina Institute
Sarasota, Florida, United States, 34239
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
University of Illinois at Chicago, Department of Ophthalmology (MC 648)
Chicago, Illinois, United States, 60612
NorthShore University Healthsystem
Glenview, Illinois, United States, 60026
United States, Kentucky
University of Kentucky, Department of Neurology
Lexington, Kentucky, United States, 40536
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Bethesda Neurology, LLC
Bethesda, Maryland, United States, 20852
United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Boston Medical Center
Boston, Massachusetts, United States, 21118
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48105
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University in St. Louis
Saint Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center and Truhlsen Eye Institute
Omaha, Nebraska, United States, 68198
United States, New Jersey
Rutgers, New Jersey Medical School
Newark, New Jersey, United States, 07103
United States, New York
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, United States, 10003
Cornell University School of Medicine
New York, New York, United States, 10583
University of Rochester, Flaum Eye Institute
Rochester, New York, United States, 14642
State University of New York at Stony Brook
Stony Brook, New York, United States, 11794
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Duke University Eye Center
Durham, North Carolina, United States, 27705
Raleigh Neurology Associates
Raleigh, North Carolina, United States, 27607
United States, Ohio
Cleveland Clinic, Cole Eye Institute
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Dean McGee Eye Institute
Oklahoma City, Oklahoma, United States, 73013
United States, Pennsylvania
University of Pennsylvania, Scheie Eye Institute
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Retina Consultants of Charleston
Charleston, South Carolina, United States, 29414
United States, Texas
University of Houston, Neuro-Ophth of Texas
Houston, Texas, United States, 77025
Houston Methodist Hospital, Blanton Eye Institute
Houston, Texas, United States, 77030
Foresight Studies
San Antonio, Texas, United States, 78240
United States, Utah
University of Utah John A. Moran Eye Center
Salt Lake City, Utah, United States, 84132
United States, Virginia
University of Virginia Health Sciences Center
Charlottesville, Virginia, United States, 22908
United States, Washington
Swedish Medical Center, CO/NOCNW
Seattle, Washington, United States, 98104
University of Washington Department of Ophthalmology
Seattle, Washington, United States, 98104
Australia, New South Wales
Sydney Eye Hospital/Save Sight Institute
Sydney, New South Wales, Australia, 2000
Australia, South Australia
Vision South Australia
Kent Town, South Australia, Australia, 5267
Australia, Victoria
The Royal Victorian Eye and Ear Hospital
Fitzroy, Victoria, Australia, 3002
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
China, Hunan
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013
China
Peking University Eye Center, The Third Hospital Peking University.
Beijing, China, 100191
Beijing Tongren Hospital, Capital Medical University
Beijing, China, 100730
Peking Union Medical College Hospital
Beijing, China, 100730
Tianjin Eye Hospital
Tianjin, China, 300000
Germany
Universitätsmedizin d. Johannes Gutenberg-Universität Mainz
Mainz, Rheinland-Pfalz, Germany, 55131
Universitätsklinikum Aachen-Augenklinik
Aachen, Germany, 52074
Universitätsklinikum Carl Gustav Carus-Dresden-Klinik und Poliklinik für Augenheilkunde
Dresden, Germany, 01307
Universitätsklinikum Münster
Münster, Germany, 48149
Universitätsklinikum Regensburg-Klinik und Poliklinik für Augenheilkunde
Regensburg, Germany, 93053
Universitäts-Augenklinik Tübingen
Tubingen, Germany, 72076
India
L V Prasad Eye Institute
Hyderabad, Andhra Pradesh, India, 500034
L V Prasad Eye Institute
Visakhapatnam, Andhra Pradesh, India, 530040
Sri Sankaradeva Nethralaya
Guwahati, Assam, India, 781028
Narayana Nethralaya
Bangalore, Karnataka,, India, 560010
PBMA'S H. V. Desai Eye Hospital
Pune, Maharashtra, India, 411060
L V Prasad Eye Institute
Bhubaneswar, Orissa, India, 751024
Sankara Nethralaya (Vision Research Foundation)
Chennai, Tami Nadu, India, 600006
Aravind Eye Hospital
Madurai, Tamil Nadu, India, 625020
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, India, 226014
ICARE Research Centre and Post Graduate Institute
Noida, Uttar Pradesh, India, 201301
Dr. Rajendra Prasad Centre for Ophthalmic Sciences, A.I.I.M.S.
New Delhi, India, 110029
Datta Meghe Institute of Medical Sciences
Wardha, India, 442005
Israel
Hadassah Medical Center
Jerusalem, Yerushalayim, Israel, 9112001
Soroka University Medical Center
Beer-Sheva, Israel, 84101
Bnai Zion Medical Center
Haifa, Israel, 31048
Rabin Medical Center, Belinson Campus
Petach-Tikva, Israel, 49100
Kaplan Medical Center
Rehovot, Israel, 76100
The Tel-Aviv Sourasky Medical Center
Tel-Aviv, Israel, 64239
The Chaim Sheba Medical Center
Tel-Hashomer, Israel, 52621
Italy
AOU Policlinico S. Orsola-Malpighi
Bologna, Italy, 40139
AOU Careggi
Firenze, Italy, 50134
Scientific Institute Auxologico Italiano
Milano, Italy
Scientific institute San Raffaele
Milano, Italy
University Eye Clinic
Parma, Italy, 43100
Singapore
Singapore National Eye Centre
Singapore, Singapore, 168751
Tan Tock Seng Hospital, Department of Ophthalmology
Singapore, Singapore, 308433
Sponsors and Collaborators
Quark Pharmaceuticals
Investigators
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Study Director: Sharon Klier, M.D. Quark Pharmaceuticals

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Responsible Party: Quark Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02341560     History of Changes
Other Study ID Numbers: QRK207
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019

Keywords provided by Quark Pharmaceuticals:
NAION

Additional relevant MeSH terms:
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Optic Nerve Diseases
Optic Neuritis
Optic Neuropathy, Ischemic
Ischemia
Pathologic Processes
Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases