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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 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG QPI-1007 at various doses
Study Locations (20)
North Carolina
- Western Carolina Retinal Associates — Asheville
- Charlotte Eye, Ear, Nose and Throat Associates, PA — Charlotte
- Duke Eye Center, Duke University Medical Center — Durham
California
- Retina-Vitreous Associates Medical Group — Beverly Hills
- Jules Stein Eye Institute, University of California, Los Angeles — Los Angeles
Florida
- Bascom Palmer at the University of Miami — Miami
- Sarasota Retina Institute — Sarasota
New York
- New York Eye and Ear Infirmary — New York
- Flaum Eye Institute, University of Rochester Medical Center — Rochester
Pennsylvania
- University of Pennsylvania, Department of Ophthalmology — Philadelphia
- Allegheny Ophthalmic and Orbital Associates — Pittsburgh
Arizona
- Retinal Consultants of Arizona — Phoenix
Colorado
- Rocky Mountain Multiple Sclerosis Center at Anschutz Medical Campus, University of Colorado — Aurora
Illinois
- University of Illinois at Chicago, Eye and Ear Infirmary — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2010-02 |
| Est. Completion | 2013-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01064505
The ClinicalTrials.gov registry entry for NCT01064505 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Quark Pharmaceuticals, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Optic Atrophy appearing as the primary indexed condition, and to 1 intervention — of which QPI-1007 at various doses is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01064505 reports 20 study locations spanning 14 distinct geographic areas — top geographies include North Carolina, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01064505 about?
NCT01064505 is a clinical study titled "Safety Study of a Single IVT Injection of QPI-1007 in Chronic Optic Nerve Atrophy and Recent Onset NAION Patients". 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 ...
What is the current status of trial NCT01064505?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2010-02. Estimated completion is 2013-04.
What conditions does trial NCT01064505 study?
This clinical trial studies the following conditions: Optic Atrophy, Non-arteritic Anterior Ischemic Optic Neuropathy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01064505?
The interventions under investigation include: QPI-1007 at various doses (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01064505?
This trial is sponsored by Quark Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01064505 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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