Safety Study of a Single IVT Injection of QPI-1007 in Chronic Optic Nerve Atrophy and Recent Onset NAION Patients
NCT ID: NCT01064505
Last Updated: 2013-05-13
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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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2010-02-28
2013-04-30
Brief Summary
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This study will determine whether QPI-1007 is safe when it is injected into the eye. The study will also reveal if there are any side effects of the drug and how long it takes for the body to clear the drug.
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Detailed Description
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1. Stratum I will enroll Optic Nerve Atrophy patients who meet necessary criteria. Stratum I will consist of a maximum of 6 cohorts and each cohort will enroll 3 to 6 evaluable patients. Enrollment in Stratum I is now closed.
2. Stratum II will enroll patients diagnosed with acute Non Arteritic Anterior Ischemic Optic Neuropathy (NAION) within 28 days of symptom onset who meet necessary criteria. Stratum II will consist of a maximum of 3 cohorts and each cohort will enroll up to 10 evaluable patients. Enrollment in Stratum II is still open.
Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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QPI-1007
QPI-1007 at various doses
Single Intravitreal Injection
Interventions
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QPI-1007 at various doses
Single Intravitreal Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clear ocular media and able to undergo adequate pupil dilation.
* Visual acuity and visual field in the non-study eye are better than or equal to the study eye
* At least 21 years old.
* Positive diagnosis of NAION with symptom onset within 28 days prior to planned dosing with QPI-1007.
* Visual acuity in the study eye is between 20/40 and light perception.
* Clear ocular media and able to undergo adequate pupil dilation.
* At least 50 years old.
Exclusion Criteria
* For either eye: history of uveitis.
Enrollment is now closed in Stratum I.
* For the study eye only: Macular disease, retinopathy, or other eye disease limiting visual acuity; prior intraocular surgery (other than Lasik) and cataract surgery within 3 months prior to dosing; glaucoma laser surgery within 1 month prior to dosing; pain on or aggravated by eye movement; history of vitreous hemorrhage; history of retinal detachment; any active inflammatory condition (e.g. conjunctivitis); glaucoma or ocular hypertension; or intraocular pressure \> 26 mmHg.
* For either eye: History of optic neuritis; or history of uveitis.
* Received any treatment for NAION prior to dosing.
* Any other abnormality which in the opinion of the investigator is suggestive of a disease other than NAION in the study eye only.
* Clinical evidence of temporal arteritis.
* History of collagen vascular disease or other inflammatory disease, or history of multiple sclerosis.
Enrollment in Stratum II is still open.
50 Years
ALL
No
Sponsors
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Quark Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Rabia Ozden, MD
Role: STUDY_DIRECTOR
Quark Pharmaceuticals
Locations
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Retinal Consultants of Arizona
Phoenix, Arizona, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Jules Stein Eye Institute, University of California, Los Angeles
Los Angeles, California, United States
Rocky Mountain Multiple Sclerosis Center at Anschutz Medical Campus, University of Colorado
Aurora, Colorado, United States
Bascom Palmer at the University of Miami
Miami, Florida, United States
Sarasota Retina Institute
Sarasota, Florida, United States
University of Illinois at Chicago, Eye and Ear Infirmary
Chicago, Illinois, United States
Kansas University Medical Center
Kansas City, Kansas, United States
University of Kentucky, Department of Ophthalmology
Lexington, Kentucky, United States
University of Minnesota, Department of Ophthalmology
Minneapolis, Minnesota, United States
Mason Eye Institute, University of Missouri
Columbia, Missouri, United States
New York Eye and Ear Infirmary
New York, New York, United States
Flaum Eye Institute, University of Rochester Medical Center
Rochester, New York, United States
Western Carolina Retinal Associates
Asheville, North Carolina, United States
Charlotte Eye, Ear, Nose and Throat Associates, PA
Charlotte, North Carolina, United States
Duke Eye Center, Duke University Medical Center
Durham, North Carolina, United States
Cole Eye Institute, Cleveland Clinic Foundation
Cleveland, Ohio, United States
University of Pennsylvania, Department of Ophthalmology
Philadelphia, Pennsylvania, United States
Allegheny Ophthalmic and Orbital Associates
Pittsburgh, Pennsylvania, United States
Alkek Eye Center Baylor College of Medicine
Houston, Texas, United States
John A. Moran Eye Center at the University of Utah
Salt Lake City, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Soroka University Medical Center, Dept of Ophthalmology
Beersheba, , Israel
Bnai Zion Medical Center
Haifa, , Israel
Rabin Medical Center, Belinson Campus, Dept of Ophthalmology
Petah Tikva, , Israel
Kaplan Medical Center, Department of Ophthalmology
Rehovot, , Israel
The Tel-Aviv Sourasky Medical Center, Dept of Ophthalmology
Tel Aviv, , Israel
The Chaim Sheba Medical Center, Dept of Ophthalmology
Tel Litwinsky, , Israel
Countries
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Other Identifiers
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QRK.007
Identifier Type: -
Identifier Source: org_study_id
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