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NCT01064505 · ClinicalTrials.gov registry record · Phase 1
Safety Study of a Single IVT Injection of QPI-1007 in Chronic Optic Nerve Atrophy and Recent Onset NAION Patients
A Phase 1 study of Optic Atrophy and Non-arteritic Anterior Ischemic Optic Neuropathy, sponsored by Quark Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 20
- Study locations
NCT01064505: Completed Phase 1 study of Optic Atrophy and Non-arteritic Anterior Ischemic Optic Neuropathy, sponsored by Quark Pharmaceuticals.
NCT01064505 is a Phase 1 study of Optic Atrophy and Non-arteritic Anterior Ischemic Optic Neuropathy that has completed, run by Quark Pharmaceuticals. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01064505, a Phase 1 study of Optic Atrophy and Non-arteritic Anterior Ischemic Optic Neuropathy, has completed, sponsored by Quark Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 20
- Study locations
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 |
What the finished NCT01064505 record still lists
NCT01064505 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
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.
NCT01064505 names 20 study sites across 14 states, led by North Carolina, California, Florida.
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.
What interventions are being tested in trial NCT01064505?
The interventions under investigation include: QPI-1007 at various doses (DRUG).
Who is sponsoring clinical trial NCT01064505?
This trial is sponsored by Quark Pharmaceuticals, which has 14 total clinical trials registered on ClinicalTrials.gov.
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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Where NCT01064505's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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