Last updated on March 2019

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

Brief description of study

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 Study 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.

Clinical Study Identifier: NCT02341560

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University of Michigan

Ann Arbor, MI United States
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Cape Coral Eye Center

Cape Coral, FL United States
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Bethesda Neurology, LLC

Bethesda, MD United States
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Sarasota Retina Institute

Sarasota, FL United States
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Stanford University

Palo Alto, CA United States
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Dean McGee Eye Institute

Oklahoma City, OK United States
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Northwestern University

Chicago, IL United States
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Foresight Studies

San Antonio, TX United States
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University of Minnesota

Minneapolis, MN United States
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University of Southern California

Los Angeles, CA United States
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Mayo Clinic

Rochester, MN United States
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The Eye Care Group

Waterbury, CT United States
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Boston Medical Center

Boston, MA United States
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NeuroEyeOrbit Institute

Los Angeles, CA United States
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Recruitment Status: Open

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