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. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
48
Single Intravitreal Injection
To determine the safety, tolerability and the dose-limiting toxicities (DLTs) of QPI 1007 when administered as a single intravitreal (IVT) injection.
Time frame: 12 Months Post-injection
To assess the pharmacokinetics (PK) of QPI-1007 when administered as a single IVT injection.
Time frame: 12 Months Post-Injection
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.
Time frame: 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.
Time frame: 12 Months Post-Injection
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...and 18 more locations