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

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 1, 2019

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

  • Drug: QPI-1007 Injection – 1.5 mg
  • Drug: QPI-1007 Injection – 3.0 mg
  • Other: Sham Injection Procedure
    • Sham Procedure

Arms, Groups and Cohorts

  • Active Comparator: single dose or multiple dose
    • QPI-1007 Injection – 1.5 mg
  • Active Comparator: single or multiple dose
    • QPI-1007 Injection – 3.0 mg
  • Sham Comparator: Sham
    • Sham injection procedure

Clinical Trial Outcome Measures

Primary Measures

  • Effect of QPI-1007 as assessed by Best Corrected Visual Acuity (BCVA)
    • Time Frame: 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
    • Time Frame: Baseline through Month 12

Secondary Measures

  • Mean change in BCVA score, as measured by ETDRS visual acuity protocol in the study eye
    • Time Frame: Day 1 through Month 12
  • Mean change of Visual Fields, as assessed by Humphrey standard automated perimetry
    • Time Frame: Day 1 through Month 12

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Quark Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sharon Klier, M.D., Study Director, Quark Pharmaceuticals

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