APR 19, 2016
Neuro-Ophthalmology/Orbit
The Neuro-Ophthalmology Research Disease Investigator Consortium (NORDIC) and Quark Pharmaceuticals are collaborating to investigate a caspase-2 inhibitor for acute nonarteritic anterior ischemic optic neuropathy (NAION). There is currently no level 1 clinical evidence supporting effective treatment for acute NAION.
The novel compound, QPI-1007, is a small interfering ribonucleic acid (siRNA) designed to temporarily block cells from producing caspase 2, which controls cell apoptosis. A phase 1 clinical trial, which was completed in April 2013, showed that a single intravitreal injection of QPI-1007 in 47 eyes was well-tolerated with no serious adverse effects.
The clinical trial (NCT02341560) will take place across 42 U.S. sites along with international sites in Israel, Australia, India, China and Germany with the hopes of enrolling 530 patients. The primary outcome measures are the effects of QPI-1007 on BCVA at 1 year.
Participants must be diagnosed with NAION in the study eye within 14 days and meet the visual field and OCT criteria for NAION. They must also be 50 to 80 years of age with a BCVA better than or equal to 15 letter score on ETDRS at presentation. All study sites have expertise in neuro-ophthalmology so rapidly referring potential subjects is essential for early intervention and will help patients get the complete evaluation required for this disorder.
Exclusion criteria include present use or history of any treatment for the current episode of NAION, prior episodes of NAION in the study eye, present use of drugs known to cause optic nerve or retinal toxicity or clinical evidence of temporal arteritis.
Contact: Kathleen Cheplo at kcheplo@quarkpharma.com or Elizabeth-Ann Moss at NORDIC at emoss@chpnet.org. More information can also be found at NORDICclinicaltrials.com