Clinical Trial: Safety Study of a Single IVT Injection of QPI-1007 in Chronic Optic Nerve Atrophy and Recent Onset NAION Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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-Arterit

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 Summary:

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.

Sponsor: Quark Pharmaceuticals

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Quark Pharmaceuticals

Dates:
Date Received: February 4, 2010
Date Started: February 2010
Date Completion:
Last Updated: May 9, 2013
Last Verified: May 2013