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.

Lead Sponsor:

Quark Pharmaceuticals

Intervention(s):

  • Drug: QPI-1007 Injection - 1.5 mg
  • Drug: QPI-1007 Injection - 3.0 mg
  • Other: Sham Injection Procedure

Phase:

Phase 2/Phase 3

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