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

NCT02341560 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 732

Last updated 2020-07-20

No results posted yet for this study

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.

Conditions

  • Non Arteritic Anterior Ischemic Optic Neuropathy

Interventions

DRUG

QPI-1007 Injection - 1.5 mg

DRUG

QPI-1007 Injection - 3.0 mg

OTHER

Sham Injection Procedure

Sham Procedure

Sponsors & Collaborators

  • Quark Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Sharon Klier, M.D. · Quark Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-24
Primary Completion
2019-07-01
Completion
2019-07-01

Countries

  • United States
  • Australia
  • China
  • Germany
  • India
  • Israel
  • Italy
  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02341560 on ClinicalTrials.gov