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Completed

NCT Number: NCT01064505

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

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.

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Key information

Conditions

Optic Atrophy Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cranial Nerve Diseases Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Metabolic Diseases Mitochondrial Diseases Nervous System Diseases Neurodegenerative Diseases Non-Arteritic Anterior Ischemic Optic Neuropathy Nutritional and Metabolic Diseases Optic Atrophies, Hereditary Optic Atrophy, Hereditary, Leber Optic Nerve Diseases Optic Neuritis Optic Neuropathy, Ischemic Retinal Degeneration Retinal Diseases Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Soroka University Medical Center, Dept of Ophthalmology, Beersheba, Israel

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About this study

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

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

QPI-1007 at various doses

Drug

Single Intravitreal Injection

Other names: QPI-1007, siRNA, small interfering RNA, short interfering RNA

Primary outcomes

  1. 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

  2. To assess the pharmacokinetics (PK) of QPI-1007 when administered as a single IVT injection.

    Time frame: 12 Months Post-Injection

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Quark Pharmaceuticals

Industry

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Feb 8, 2010
Registry last updated
May 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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