Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 in Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

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.

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • other: Sham Injection Procedure
  • drug: QPI-1007 Injection - 1.5 mg
  • drug: QPI-1007 Injection - 3.0 mg

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

Ages Eligible for Study

50 Years - 80 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mariana Nunez
650-497-7846
Not Recruiting

Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation,  mobile application development, and pharmaceutical trials.  

Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.