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Safety Study of a Single IVT Injection of QPI-1007 in Chronic Optic Nerve Atrophy and Recent Onset NAION Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01064505
Recruitment Status : Completed
First Posted : February 8, 2010
Last Update Posted : May 13, 2013
Sponsor:
Information provided by (Responsible Party):
Quark Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE February 4, 2010
First Posted Date  ICMJE February 8, 2010
Last Update Posted Date May 13, 2013
Study Start Date  ICMJE February 2010
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2010)
  • To determine the safety, tolerability and the dose-limiting toxicities (DLTs) of QPI 1007 when administered as a single intravitreal (IVT) injection. [ Time Frame: 12 Months Post-injection ]
  • To assess the pharmacokinetics (PK) of QPI-1007 when administered as a single IVT injection. [ Time Frame: 12 Months Post-Injection ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2010)
  • To determine the presence of and to describe any anatomical changes in the optic nerve head and retina observed following the administration of a single IVT injection of QPI 1007. [ Time Frame: 12 Months Post-Injection ]
  • To assess any changes in visual acuity and visual field observed following the administration of a single IVT injection of QPI-1007. [ Time Frame: 12 Months Post-Injection ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of a Single IVT Injection of QPI-1007 in Chronic Optic Nerve Atrophy and Recent Onset NAION Patients
Official Title  ICMJE A Phase I Open-Label, Dose Escalation Trial of QPI-1007 Delivered by a Single Intravitreal Injection to Patients With Optic Nerve Atrophy (Stratum I) and Acute Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) (Stratum II)
Brief Summary

This is an open-label, dose escalation, safety, tolerability and pharmacokinetic study, where active study drug (QPI-1007) will be given to all patients who participate.

This study will determine whether QPI-1007 is safe when it is injected into the eye. The study will also reveal if there are any side effects of the drug and how long it takes for the body to clear the drug.

Detailed Description

Patients will be enrolled according to one of two sets of criteria designated as Stratum I and Stratum II.

  1. Stratum I will enroll Optic Nerve Atrophy patients who meet necessary criteria. Stratum I will consist of a maximum of 6 cohorts and each cohort will enroll 3 to 6 evaluable patients. Enrollment in Stratum I is now closed.
  2. Stratum II will enroll patients diagnosed with acute Non Arteritic Anterior Ischemic Optic Neuropathy (NAION) within 28 days of symptom onset who meet necessary criteria. Stratum II will consist of a maximum of 3 cohorts and each cohort will enroll up to 10 evaluable patients. Enrollment in Stratum II is still open.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Optic Atrophy
  • Non-arteritic Anterior Ischemic Optic Neuropathy
Intervention  ICMJE Drug: QPI-1007 at various doses
Single Intravitreal Injection
Other Names:
  • QPI-1007
  • siRNA
  • small interfering RNA
  • short interfering RNA
Study Arms  ICMJE Experimental: QPI-1007
Intervention: Drug: QPI-1007 at various doses
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2013)
48
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2010)
54
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Stratum I (Chronic Optic Nerve Atrophy) Inclusion Criteria:

  • "Legally blind" in the study eye as the result of an irreversible condition affecting the posterior segment of the eye.
  • Clear ocular media and able to undergo adequate pupil dilation.
  • Visual acuity and visual field in the non-study eye are better than or equal to the study eye
  • At least 21 years old.

Key Stratum I (Chronic Optic Nerve Atrophy) Exclusion Criteria:

  • For the study eye only: history of any IVT injection or vitrectomy, vitreous hemorrhage, retinal detachment, or active inflammatory condition (e.g. conjunctivitis).
  • For either eye: history of uveitis.

Enrollment is now closed in Stratum I.

Key Stratum II (Acute NAION) Inclusion Criteria:

  • Positive diagnosis of NAION with symptom onset within 28 days prior to planned dosing with QPI-1007.
  • Visual acuity in the study eye is between 20/40 and light perception.
  • Clear ocular media and able to undergo adequate pupil dilation.
  • At least 50 years old.

Key Stratum II (Acute NAION) Exclusion Criteria:

  • For the study eye only: Macular disease, retinopathy, or other eye disease limiting visual acuity; prior intraocular surgery (other than Lasik) and cataract surgery within 3 months prior to dosing; glaucoma laser surgery within 1 month prior to dosing; pain on or aggravated by eye movement; history of vitreous hemorrhage; history of retinal detachment; any active inflammatory condition (e.g. conjunctivitis); glaucoma or ocular hypertension; or intraocular pressure > 26 mmHg.
  • For either eye: History of optic neuritis; or history of uveitis.
  • Received any treatment for NAION prior to dosing.
  • Any other abnormality which in the opinion of the investigator is suggestive of a disease other than NAION in the study eye only.
  • Clinical evidence of temporal arteritis.
  • History of collagen vascular disease or other inflammatory disease, or history of multiple sclerosis.

Enrollment in Stratum II is still open.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (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 Israel,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01064505
Other Study ID Numbers  ICMJE QRK.007
Has Data Monitoring Committee No
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: Rabia Ozden, MD Quark Pharmaceuticals
PRS Account Quark Pharmaceuticals
Verification Date May 2013

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