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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 : Terminated (An interim analysis did not warrant to continue enrollment)
First Posted : January 19, 2015
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Quark Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE January 13, 2015
First Posted Date  ICMJE January 19, 2015
Last Update Posted Date July 16, 2019
Actual Study Start Date  ICMJE February 24, 2016
Actual Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2015)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 13, 2015)
Effect of QPI-1007 as assessed by ophthalmic evaluations and Best Corrected Visual Acuity (BCVA) [ Time Frame: Day 0 (after injection) through Month 12 ]
Change History Complete list of historical versions of study NCT02341560 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
  • 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 [ Time Frame: Day 1 through Month 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2015)
  • Evaluation of structural changes in the retina as assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) [ Time Frame: Day 0 (after injection) 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: Day 0 (after injection) through Month 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 in Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
Official Title  ICMJE 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)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Non Arteritic Anterior Ischemic Optic Neuropathy
Intervention  ICMJE
  • Drug: QPI-1007 Injection - 1.5 mg
    Other Name: QPI-1007
  • Drug: QPI-1007 Injection - 3.0 mg
    Other Name: QPI-1007
  • Other: Sham Injection Procedure
    Sham Procedure
    Other Name: Sham
Study Arms  ICMJE
  • Active Comparator: single dose or multiple dose
    QPI-1007 Injection - 1.5 mg
    Intervention: Drug: QPI-1007 Injection - 1.5 mg
  • Active Comparator: single or multiple dose
    QPI-1007 Injection - 3.0 mg
    Intervention: Drug: QPI-1007 Injection - 3.0 mg
  • Sham Comparator: Sham
    Sham injection procedure
    Intervention: Other: Sham Injection Procedure
Publications * Davis JL. The Blunt End: Surgical Challenges of Gene Therapy for Inherited Retinal Diseases. Am J Ophthalmol. 2018 Dec;196:xxv-xxix. doi: 10.1016/j.ajo.2018.08.038. Epub 2018 Sep 5. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 12, 2019)
732
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2015)
352
Actual Study Completion Date  ICMJE July 1, 2019
Actual Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   China,   Germany,   India,   Israel,   Italy,   Singapore,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02341560
Other Study ID Numbers  ICMJE QRK207
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Quark Pharmaceuticals
Study Sponsor  ICMJE Quark Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sharon Klier, M.D. Quark Pharmaceuticals
PRS Account Quark Pharmaceuticals
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP