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

Optic Atrophy Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01064505
• Other study ID #: QRK.007
• Status: Completed
• Phase: Phase 1
• First received: February 4, 2010
• Last updated: May 9, 2013
• Start date: February 2010
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: Quark Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Atrophy
• Ischemia
• Non-arteritic Anterior Ischemic Optic Neuropathy
• Optic Atrophy
• Optic Nerve Diseases
• Optic Neuropathy, Ischemic

Intervention

Drug:
• QPI-1007 at various doses
Single Intravitreal Injection

Locations

Country	Name	City	State
Israel	Soroka University Medical Center, Dept of Ophthalmology	Beer-Sheva
Israel	Bnai Zion Medical Center	Haifa
Israel	Rabin Medical Center, Belinson Campus, Dept of Ophthalmology	Petach Tikva
Israel	Kaplan Medical Center, Department of Ophthalmology	Rehovot
Israel	The Tel-Aviv Sourasky Medical Center, Dept of Ophthalmology	Tel-Aviv
Israel	The Chaim Sheba Medical Center, Dept of Ophthalmology	Tel-Hashomer
United States	Western Carolina Retinal Associates	Asheville	North Carolina
United States	Rocky Mountain Multiple Sclerosis Center at Anschutz Medical Campus, University of Colorado	Aurora	Colorado
United States	Retina-Vitreous Associates Medical Group	Beverly Hills	California
United States	Charlotte Eye, Ear, Nose and Throat Associates, PA	Charlotte	North Carolina
United States	University of Illinois at Chicago, Eye and Ear Infirmary	Chicago	Illinois
United States	Cole Eye Institute, Cleveland Clinic Foundation	Cleveland	Ohio
United States	Mason Eye Institute, University of Missouri	Columbia	Missouri
United States	Duke Eye Center, Duke University Medical Center	Durham	North Carolina
United States	Alkek Eye Center Baylor College of Medicine	Houston	Texas
United States	Kansas University Medical Center	Kansas City	Kansas
United States	University of Kentucky, Department of Ophthalmology	Lexington	Kentucky
United States	Jules Stein Eye Institute, University of California, Los Angeles	Los Angeles	California
United States	Bascom Palmer at the University of Miami	Miami	Florida
United States	University of Minnesota, Department of Ophthalmology	Minneapolis	Minnesota
United States	New York Eye and Ear Infirmary	New York	New York
United States	University of Pennsylvania, Department of Ophthalmology	Philadelphia	Pennsylvania
United States	Retinal Consultants of Arizona	Phoenix	Arizona
United States	Allegheny Ophthalmic and Orbital Associates	Pittsburgh	Pennsylvania
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Flaum Eye Institute, University of Rochester Medical Center	Rochester	New York
United States	John A. Moran Eye Center at the University of Utah	Salt Lake City	Utah
United States	Sarasota Retina Institute	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Quark Pharmaceuticals

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the safety, tolerability and the dose-limiting toxicities (DLTs) of QPI 1007 when administered as a single intravitreal (IVT) injection.		12 Months Post-injection	No
Primary	To assess the pharmacokinetics (PK) of QPI-1007 when administered as a single IVT injection.		12 Months Post-Injection	No
Secondary	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.		12 Months Post-Injection	No
Secondary	To assess any changes in visual acuity and visual field observed following the administration of a single IVT injection of QPI-1007.		12 Months Post-Injection	No