Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 in Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

Purpose

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.

Condition

  • Non Arteritic Anterior Ischemic Optic Neuropathy

Eligibility

Eligible Ages
Between 50 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
single dose or multiple dose 		QPI-1007 Injection - 1.5 mg
  • Drug: QPI-1007 Injection - 1.5 mg
    Other names:
    • QPI-1007
Active Comparator
single or multiple dose 		QPI-1007 Injection - 3.0 mg
  • Drug: QPI-1007 Injection - 3.0 mg
    Other names:
    • QPI-1007
Sham Comparator
Sham 		Sham injection procedure
  • Other: Sham Injection Procedure
    Sham Procedure
    Other names:
    • Sham

Recruiting Locations

More Details

NCT ID
NCT02341560
Status
Terminated
Sponsor
Quark Pharmaceuticals

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.