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

Status:	Archived
Conditions:	Peripheral Vascular Disease, Ocular
Therapuetic Areas:	Cardiology / Vascular Diseases, Ophthalmology
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	February 2010
End Date:	December 2013

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)

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 14 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.

We found this trial at

sites

Duke University Hospital

Durham, North Carolina 27705

from

Durham, NC