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Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 in Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
Not Recruiting
Trial ID: NCT02341560
Purpose
This study will determine the effect of QPI-1007 on visual function in subjects with
recent-onset NAION and assess the safety and tolerability of intravitreal injections of
QPI-1007 in this population. This study will also evaluate the structural changes in the
retina following administration of QPI-1007.
Official Title
A Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 Delivered By Single or Multi-Dose Intravitreal Injection(s) to Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
Stanford Investigator(s)
Y. Joyce Liao, MD, PhD
Stanford Medicine Professor of Ophthalmology and Professor of Neurology
Heather E. Moss, MD, PhD
Professor of Ophthalmology and of Neurology
Theodore Leng, MD, FACS
Associate Professor of Ophthalmology and, by courtesy, of Anesthesiology, Perioperative and Pain Medicine (Adult MSD)
Shannon Beres, MD
Clinical Associate Professor, Neurology Clinical Associate Professor (By courtesy), Ophthalmology
Steven Sanislo, MD
Clinical Professor, Ophthalmology
Eligibility
Key Inclusion Criteria:
- Positive diagnosis of first episode of NAION in the study eye with symptom onset
within 14 days prior to planned study drug administration/sham procedure
- Best corrected visual acuity score in the study eye is better than or equal to 15
letter score, measured using the ETDRS visual acuity protocol at Day 1 prior to study
drug administration/sham procedure.
- Clear ocular media and able to undergo adequate pupil dilation to allow a good fundus
examination
Key Exclusion Criteria:
- Present use or history of any treatment for the current episode of NAION, including
systemic steroids, brimonidine, or traditional Chinese herbal medicine
- Prior episode of NAION in the study eye only
- Present use of drugs known to cause optic nerve or retinal toxicity at Day
1/Randomization, such as: chloroquine or hydroxychloroquine, ethambutol, Vigabatrin.
Subjects who need to be prescribed any of these drugs during the course of the study
will be discontinued from the trial.
- Any medical condition, concomitant therapy, or previous incisional or laser surgery
that, in the opinion of the Investigator, would preclude IVT injection in the study
eye only
- Clinical evidence of temporal arteritis
Intervention(s):
other: Sham Injection Procedure
drug: QPI-1007 Injection - 1.5 mg
drug: QPI-1007 Injection - 3.0 mg
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Mariana Nunez
650-497-7846