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 20, 2020
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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 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 732 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) |
Actual Study Start Date : | February 24, 2016 |
Actual Primary Completion Date : | July 1, 2019 |
Actual Study Completion Date : | July 1, 2019 |

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

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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 |
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

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

Study Director: | Sharon Klier, M.D. | Quark Pharmaceuticals |
Responsible Party: | Quark Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT02341560 |
Other Study ID Numbers: |
QRK207 |
First Posted: | January 19, 2015 Key Record Dates |
Last Update Posted: | July 20, 2020 |
Last Verified: | July 2019 |
NAION |
Optic Nerve Diseases Optic Neuropathy, Ischemic Ischemia Pathologic Processes Nervous System Diseases |
Cranial Nerve Diseases Eye Diseases Vascular Diseases Cardiovascular Diseases |