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)
ID Number NYEE-16-08Principal Investigator(s)
Department(s) or Division(s)
The purpose of this research is to evaluate vision loss because there was not enough blood flow to the nerve tissue in the eye. This is sometimes called a stroke of the optic nerve. The medical term for this disease is Nonarteritic Anterior Ischemic Optic Neuropathy (NAION).
This study will test the experimental drug, QPI-1007. QPI-1007 is being developed to treat vision loss that can occur when there is not enough blood flow to the nerve tissue in the eye; that is, after a stroke of the optic nerve or NAION. QPI-1007 is an investigational drug called a “small interfering ribonucleic acid”, or “siRNA”. siRNA drugs are designed to temporarily block cells from making specific proteins called “caspase 2”. High levels of caspase 2 have been found when cells are damaged due to lack of oxygen.
Temporarily stopping the nerve cells in the eye from making caspase 2 after they are damaged could give the cells more time to make repairs which may prevent further loss of vision and possibly improve vision.
Participants need to be of 50 to 80 years of age with a positive diagnosis of first episode NAION in the study eye with symptom onset within 14 days prior to the screening visit.
Participants needs to have a best corrected visual acuity score in the study eye of 20/125 and better. Participants must not presently use or have had used treatment for the current episode of NAION, including systemic steroids, brimonidine, or traditional Chinese herbal medicine.
Participants are compensated for all study visits completed.
Recruiting Patients: Yes