Non Arteritic Anterior Ischemic Optic Neuropathy
Conditions
Keywords
NAION
Brief summary
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.
Detailed description
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.
Interventions
DRUGQPI-1007 Injection - 1.5 mg
DRUGQPI-1007 Injection - 3.0 mg
Sham Procedure
Sponsors
Quark Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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 examination 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 eye only * Clinical evidence of temporal arteritis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of QPI-1007 as assessed by Best Corrected Visual Acuity (BCVA) | Baseline through Month 12 |
| Safety and tolerability of QPI-1007 as assessed by adverse events (AE), laboratory evaluations, ECGs, ophthalmic evaluations, slit lamp anterior/posterior examinations, intraocular pressure measurements, presence/absence of vitreous inflammation | Baseline through Month 12 |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in BCVA score, as measured by ETDRS visual acuity protocol in the study eye | Day 1 through Month 12 |
| Mean change of Visual Fields, as assessed by Humphrey standard automated perimetry | Day 1 through Month 12 |
Countries
Australia, China, Germany, India, Israel, Italy, Singapore, United States
Outcome results
None listed