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.
- Non Arteritic Anterior Ischemic Optic Neuropathy
- Eligible Ages
- Between 50 Years and 80 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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
- 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
- Phase 2/Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
single dose or multiple dose
|QPI-1007 Injection - 1.5 mg||
single or multiple dose
|QPI-1007 Injection - 3.0 mg||
|Sham injection procedure||
- NCT ID
- Quark Pharmaceuticals
This is a double masked, randomized, sham-controlled efficacy and safety study that will enroll approximately 800 subjects with recent-onset NAION. Subjects will be randomized into one of 3 groups in a 1:1:1 ratio, and assigned to receive QPI-1007 and/or a sham procedure. Subjects will have a two in three (66%) chance of receiving active treatment (no sham procedure) and a one in three (33%) chance of receiving sham procedure (no active treatment). Total study time involvement is approximately 12 months.