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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)

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Quark Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Quark Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02341560
First received: January 13, 2015
Last updated: March 17, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Nonarteritic Anterior Ischemic Optic Neuropathy Drug: QPI-1007 Injection - single low dose Drug: QPI-1007 Injection - single high dose Drug: QPI-1007 Injection - multiple low dose Drug: QPI-1007 Injection - multiple high dose Other: Sham Injection Procedure Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
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 Ischemic Optic Neuropathy (NAION)

Resource links provided by NLM:


Further study details as provided by Quark Pharmaceuticals:

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

Estimated Enrollment: 530
Study Start Date: October 2015
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cohort 1
QPI-1007 Injection - single low dose
Drug: QPI-1007 Injection - single low dose
QPI-1007 Injection, single low dose
Other Name: QPI-1007
Active Comparator: Cohort 2
QPI-1007 Injection - single high dose
Drug: QPI-1007 Injection - single high dose
QPI-1007 Injection, single high dose
Other Name: QPI-1007
Active Comparator: Cohort 3
QPI-1007 Injection - multiple low dose
Drug: QPI-1007 Injection - multiple low dose
QPI-1007 Injection, multiple low dose
Other Name: QPI-1007
Active Comparator: Cohort 4
QPI-1007 Injection - multiple high dose
Drug: QPI-1007 Injection - multiple high dose
QPI-1007 Injection, multiple high low dose
Other Name: QPI-1007
Sham Comparator: Cohort 5
Sham injection procedure
Other: Sham Injection Procedure
Sham Procedure
Other Name: Sham

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02341560

Contacts
Contact: Robert Shopbell 510.402.4005 rshopbell@quarkpharma.com

  Show 90 Study Locations
Sponsors and Collaborators
Quark Pharmaceuticals
Investigators
Study Director: Sharon Klier, M.D. Quark Pharmaceuticals
  More Information

Responsible Party: Quark Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02341560     History of Changes
Other Study ID Numbers: QRK207
Study First Received: January 13, 2015
Last Updated: March 17, 2017

Keywords provided by Quark Pharmaceuticals:
NAION

Additional relevant MeSH terms:
Ischemia
Optic Nerve Diseases
Optic Neuropathy, Ischemic
Pathologic Processes
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 26, 2017