Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 in Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Non Arteritic Anterior Ischemic Optic Neuropathy

Intervention / Treatment
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* Drug: QPI-1007 Injection - 1.5 mg
* Drug: QPI-1007 Injection - 3.0 mg
* Other: Sham Injection Procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: single dose or multiple dose<br>QPI-1007 Injection - 1.5 mg | Drug: QPI-1007 Injection - 1.5 mg<br> <br> * Other names: QPI-1007;|
| Active Comparator: single or multiple dose<br>QPI-1007 Injection - 3.0 mg | Drug: QPI-1007 Injection - 3.0 mg<br> <br> * Other names: QPI-1007;|
| Sham Comparator: Sham<br>Sham injection procedure | Other: Sham Injection Procedure<br>* Sham Procedure<br>* Other names: Sham;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of QPI-1007 as assessed by Best Corrected Visual Acuity (BCVA) |  | 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 |  | Baseline through Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in BCVA score, as measured by ETDRS visual acuity protocol in the study eye |  | Day 1 through Month 12 | 
| Mean change of Visual Fields, as assessed by Humphrey standard automated perimetry |  | Day 1 through Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NAION