Safety Study of a Single IVT Injection of QPI-1007 in Chronic Optic Nerve Atrophy and Recent Onset NAION Patients
A Phase I Open-Label, Dose Escalation Trial of QPI-1007 Delivered by a Single Intravitreal Injection to Patients With Optic Nerve Atrophy (Stratum I) and Acute Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) (Stratum II)
1 other identifier
interventional
48
2 countries
28
Brief Summary
This is an open-label, dose escalation, safety, tolerability and pharmacokinetic study, where active study drug (QPI-1007) will be given to all patients who participate. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2010
Typical duration for phase_1
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 4, 2010
CompletedFirst Posted
Study publicly available on registry
February 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedMay 13, 2013
May 1, 2013
3.2 years
February 4, 2010
May 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To determine the safety, tolerability and the dose-limiting toxicities (DLTs) of QPI 1007 when administered as a single intravitreal (IVT) injection.
12 Months Post-injection
To assess the pharmacokinetics (PK) of QPI-1007 when administered as a single IVT injection.
12 Months Post-Injection
Secondary Outcomes (2)
To determine the presence of and to describe any anatomical changes in the optic nerve head and retina observed following the administration of a single IVT injection of QPI 1007.
12 Months Post-Injection
To assess any changes in visual acuity and visual field observed following the administration of a single IVT injection of QPI-1007.
12 Months Post-Injection
Study Arms (1)
QPI-1007
EXPERIMENTALInterventions
Single Intravitreal Injection
Eligibility Criteria
You may qualify if:
- "Legally blind" in the study eye as the result of an irreversible condition affecting the posterior segment of the eye.
- 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.
You may not qualify if:
- For the study eye only: history of any IVT injection or vitrectomy, vitreous hemorrhage, retinal detachment, or active inflammatory condition (e.g. conjunctivitis).
- For either eye: history of uveitis.
- Enrollment is now closed in Stratum I.
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Retinal Consultants of Arizona
Phoenix, Arizona, 85014, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211, United States
Jules Stein Eye Institute, University of California, Los Angeles
Los Angeles, California, 90049, United States
Rocky Mountain Multiple Sclerosis Center at Anschutz Medical Campus, University of Colorado
Aurora, Colorado, 80045, United States
Bascom Palmer at the University of Miami
Miami, Florida, 33136, United States
Sarasota Retina Institute
Sarasota, Florida, 34239, United States
University of Illinois at Chicago, Eye and Ear Infirmary
Chicago, Illinois, 60612, United States
Kansas University Medical Center
Kansas City, Kansas, 66208, United States
University of Kentucky, Department of Ophthalmology
Lexington, Kentucky, 40536, United States
University of Minnesota, Department of Ophthalmology
Minneapolis, Minnesota, 55455, United States
Mason Eye Institute, University of Missouri
Columbia, Missouri, 65212, United States
New York Eye and Ear Infirmary
New York, New York, 10003, United States
Flaum Eye Institute, University of Rochester Medical Center
Rochester, New York, 14642, United States
Western Carolina Retinal Associates
Asheville, North Carolina, 28803, United States
Charlotte Eye, Ear, Nose and Throat Associates, PA
Charlotte, North Carolina, 28210, United States
Duke Eye Center, Duke University Medical Center
Durham, North Carolina, 27705, United States
Cole Eye Institute, Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
University of Pennsylvania, Department of Ophthalmology
Philadelphia, Pennsylvania, 19104, United States
Allegheny Ophthalmic and Orbital Associates
Pittsburgh, Pennsylvania, 15212, United States
Alkek Eye Center Baylor College of Medicine
Houston, Texas, 77030, United States
John A. Moran Eye Center at the University of Utah
Salt Lake City, Utah, 84132, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Soroka University Medical Center, Dept of Ophthalmology
Beersheba, 84101, Israel
Bnai Zion Medical Center
Haifa, 33394, Israel
Rabin Medical Center, Belinson Campus, Dept of Ophthalmology
Petah Tikva, 49100, Israel
Kaplan Medical Center, Department of Ophthalmology
Rehovot, 76100, Israel
The Tel-Aviv Sourasky Medical Center, Dept of Ophthalmology
Tel Aviv, 64239, Israel
The Chaim Sheba Medical Center, Dept of Ophthalmology
Tel Litwinsky, 52621, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rabia Ozden, MD
Quark Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2010
First Posted
February 8, 2010
Study Start
February 1, 2010
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
May 13, 2013
Record last verified: 2013-05