Non-arteritic Anterior Ischemic Optic Neuropathy, Optic Atrophy
Conditions
Keywords
Ocular Neuroprotection, ocular neuroprotectant, NAION, NAAION, Non-arteritic ischemic optic neuropathy, Non-arteritic anterior ischemic optic neuropathy, chronic optic nerve atrophy, optic nerve atrophy, retinal degeneration, optic neuritis, end stage glaucoma, Leber's hereditary optic neuropathy
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.
Detailed description
Patients will be enrolled according to one of two sets of criteria designated as Stratum I and Stratum II. 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.
Interventions
DRUGQPI-1007 at various doses
Single Intravitreal Injection
Sponsors
Quark Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Stratum I (Chronic Optic Nerve Atrophy) Inclusion Criteria: * 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. Key Stratum I (Chronic Optic Nerve Atrophy)
Exclusion criteria
* 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. Key Stratum II (Acute NAION) Inclusion Criteria: * 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. Key Stratum II (Acute NAION)
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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. | 12 Months Post-Injection |
Countries
Israel, United States
Outcome results
None listed