NCT02341560

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

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)

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 732 (actual)
• Sponsor: Quark Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Arteritic Anterior Ischemic Optic Neuropathy

Interventions

Type	Name	Description
DRUG	QPI-1007 Injection - 1.5 mg
DRUG	QPI-1007 Injection - 3.0 mg
OTHER	Sham Injection Procedure	Sham Procedure

Timeline

• Start date: 2016-02-24
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2015-01-19
• Last updated: 2020-07-20

Locations

85 sites across 8 countries: United States, Australia, China, Germany, India, Israel, Italy, Singapore