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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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

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 Summary: This is a double masked, randomized, sham-controlled efficacy and safety study that will enroll approximately 530 subjects with recent-onset NAION. Subjects will be randomized into one of 5 groups in a 1:1:1:1:1 ratio, and assigned to receive QPI-1007 and/or a sham procedure. Subjects will have a one in five (20%) chance of receiving sham procedure (no active treatment). Total study time involvement is approximately 12 months.
Sponsor: Quark Pharmaceuticals

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Effect of QPI-1007 as assessed by ophthalmic evaluations and Best Corrected Visual Acuity (BCVA) [ Time Frame: Day 0 (after injection) through Month 12 ]

Current Secondary Outcome:

  • 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 using the SITA standard 24-2 testing protocol in the study eye [ Time Frame: Day 1 through Month 12 ]


Original Secondary Outcome:

  • Evaluation of structural changes in the retina as assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) [ Time Frame: Day 0 (after injection) 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: Day 0 (after injection) through Month 12 ]


Information By: Quark Pharmaceuticals

Dates:
Date Received: January 13, 2015
Date Started: October 2015
Date Completion: July 2019
Last Updated: March 17, 2017
Last Verified: March 2017