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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.
Patients will be enrolled according to one of two sets of criteria designated as Stratum I and Stratum II.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QPI-1007 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QPI-1007 at various doses | Drug | Single Intravitreal Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Key Stratum I (Chronic Optic Nerve Atrophy) Inclusion Criteria:
Key Stratum I (Chronic Optic Nerve Atrophy) Exclusion Criteria:
Enrollment is now closed in Stratum I.
Key Stratum II (Acute NAION) Inclusion Criteria:
Key Stratum II (Acute NAION) Exclusion Criteria:
Enrollment in Stratum II is still open.
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| Name | Affiliation | Role |
|---|---|---|
| Rabia Ozden, MD | Quark Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Consultants of Arizona | Phoenix | Arizona | 85014 | United States | ||
| Retina-Vitreous Associates Medical Group |
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| 12 Months Post-Injection |
| 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 |
| ID | Term |
|---|---|
| D009896 | Optic Atrophy |
| D018917 | Optic Neuropathy, Ischemic |
| D012162 | Retinal Degeneration |
| D009902 | Optic Neuritis |
| D029242 | Optic Atrophy, Hereditary, Leber |
| ID | Term |
|---|---|
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D015785 | Eye Diseases, Hereditary |
| D012164 | Retinal Diseases |
| D015418 | Optic Atrophies, Hereditary |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D028361 | Mitochondrial Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D034741 | RNA, Small Interfering |
| ID | Term |
|---|---|
| D016372 | RNA, Antisense |
| D016375 | Antisense Elements (Genetics) |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012313 | RNA |
| D009696 | Nucleic Acids |
| D058727 | RNA, Small Untranslated |
| D022661 | RNA, Untranslated |
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