Non-Arteritic Anterior Ischemic Optic Neuropathy

ARK Study

About The Study:

Sponsored by Quark Pharmaceuticals, the purpose of this study is to test whether an investigational drug called QPI-1007 helps prevent loss of visual acuity, in participants with Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION). This study will assess the safety and tolerability of QPI-1007

All participants will be randomized to one of five study groups:

Group A—One 1.5 mg of QPI-1007 administered by intravitreal injection followed by 2 sham injections
Group B—One 3 mg of QPI-1007 administered by intravitreal injection followed by 2 sham injections
Group C—1.5 mg of QPI-1007 administered by intravitreal injection every 2 months, 3 injections total
Group D—3 mg of QPI-1007 administered by intravitreal injection every 2 months, 3 injections total
Group E—3 Sham injections

Participants participating in this study will make up to 8 scheduled study visits over a period of 12 months. Each visit will last anywhere from 2-5 hours.

Key Inclusion Criteria:

NAION in the study eye, with symptom onset within 14 days
Age 50-80 years

Key Exclusion Criteria:

Present use or history or any treatment for the current episode of NAION
Prior episode of NAION in the study eye only
Bilateral (simultaneous) NAION
Macular disease, proliferative diabetic retinopathy or other eye disease limiting visual acuity in study eye only
Pain on eye movement in either eye
Glaucoma or OHT in the study eye

For additional information about the trials or to refer a patient, contact the study coordinators:

Ashton Leone, MPH at (434) 243-5737 or aml7q@virginia.edu
Tamika Mercer at (434) 243-2852 or tmm2v@virginia.edu