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.
- Drug: QPI-1007 Injection - 1.5 mg
- Drug: QPI-1007 Injection - 3.0 mg
- Other: Sham Injection Procedure
Phase 2/Phase 3
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
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
- Clinical evidence of temporal arteritis
Ages Eligible for Study
50 Years - 80 Years
Genders Eligible for Study