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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)

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ClinicalTrials.gov Identifier: NCT02341560
Recruitment Status : Recruiting
First Posted : January 19, 2015
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Quark Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non Arteritic Anterior Ischemic Optic Neuropathy Drug: QPI-1007 Injection - 1.5 mg Drug: QPI-1007 Injection - 3.0 mg Other: Sham Injection Procedure Phase 2 Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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)
Study Start Date : October 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: single dose or multiple dose
QPI-1007 Injection - 1.5 mg
 Drug: QPI-1007 Injection - 1.5 mg
Other Name: QPI-1007
Active Comparator: single or multiple dose
QPI-1007 Injection - 3.0 mg
 Drug: QPI-1007 Injection - 3.0 mg
Other Name: QPI-1007
Sham Comparator: Sham
Sham injection procedure
 Other: Sham Injection Procedure
Sham Procedure
Other Name: Sham


Outcome Measures
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Primary Outcome Measures :
  1. Effect of QPI-1007 as assessed by Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline through Month 12 ]
  2. 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 :
  1. Mean change in BCVA score, as measured by ETDRS visual acuity protocol in the study eye [ Time Frame: Day 1 through Month 12 ]
  2. Mean change of Visual Fields, as assessed by Humphrey standard automated perimetry [ Time Frame: Day 1 through Month 12 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341560


Contacts
Contact: Robert Shopbell 510.402.4005 rshopbell@quarkpharma.com

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Sponsors and Collaborators
Quark Pharmaceuticals
Investigators
Study Director: Sharon Klier, M.D. Quark Pharmaceuticals
More Information
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Responsible Party: Quark Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02341560     History of Changes
Other Study ID Numbers: QRK207
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: April 2018

Keywords provided by Quark Pharmaceuticals:
NAION

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