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

NCT01064505 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2013-05-13

No results posted yet for this study

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.

Conditions

  • Optic Atrophy
  • Non-arteritic Anterior Ischemic Optic Neuropathy

Interventions

DRUG

QPI-1007 at various doses

Single Intravitreal Injection

Sponsors & Collaborators

  • Quark Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Rabia Ozden, MD · Quark Pharmaceuticals

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01064505 on ClinicalTrials.gov