Safety Study of a Single IVT Injection of QPI-1007 in Chronic Optic Nerve Atrophy and Recent Onset NAION Patients
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|ClinicalTrials.gov Identifier: NCT01064505|
Recruitment Status : Completed
First Posted : February 8, 2010
Last Update Posted : May 13, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Optic Atrophy Non-arteritic Anterior Ischemic Optic Neuropathy||Drug: QPI-1007 at various doses||Phase 1|
Patients will be enrolled according to one of two sets of criteria designated as Stratum I and Stratum II.
- 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.
- 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 (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
Drug: QPI-1007 at various doses
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01064505
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|Study Director:||Rabia Ozden, MD||Quark Pharmaceuticals|