Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 in Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
Trial ID or NCT#
NCT02341560
Status
NOT RECRUITING
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)
Eligibility Criteria
Ages Eligible for Study: 50 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
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
Investigator(s)
Y. Joyce Liao, MD, PhD
Neuro-ophthalmology specialist
Stanford Medicine Professor of Ophthalmology and Professor of Neurology and Neurological Sciences
Shannon Beres, MD
Neuro-ophthalmology specialist,
General neurologist
Clinical Associate Professor, Neurology
Clinical Associate Professor (By courtesy), Ophthalmology
Heather E. Moss, MD, PhD
Neuro-ophthalmology specialist
Professor of Ophthalmology and of Neurology and Neurological Sciences
Theodore Leng, MD, FACS
Ophthalmologist
Associate Professor of Ophthalmology (Ophthalmology Research/Clinical Trials) and, by courtesy, of Anesthesiology, Perioperative and Pain Medicine (MSD)
Contact us to find out if this trial is right for you.
Contact
Mariana Nunez
650-497-7846
View on ClinicalTrials.gov
