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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.
1. Stratum I will enroll Optic Nerve Atrophy patients who meet necessary criteria.
2. Stratum II will enroll patients diagnosed with acute Non Arteritic Anterior Ischemic Optic Neuropathy (NAION) within 14 days of symptom onset who meet necessary criteria.
Stratum I will consist of a maximum of 4 cohorts and each cohort will enroll 3 to 6 evaluable patients. Stratum II will consist of a maximum of 3 cohorts and each cohort will enroll up to 10 evaluable patients.
Allocation: Non-Randomized, Control: Dose Comparison, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
Chronic Optic Nerve Atrophy
QPI-1007 at various doses
Retina-Vitreous Associates Medical Group
Published on BioPortfolio: 2014-08-27T03:16:03-0400
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