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

Quark Pharmaceuticals

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Non Arteritic Anterior Ischemic Optic Neuropathy

Treatments: Other: Sham Injection Procedure; Drug: QPI-1007 Injection - 3.0 mg; Drug: QPI-1007 Injection - 1.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02341560

QRK207

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 732 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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732 participants in 3 patient groups

single dose or multiple dose

Active Comparator group

Description:

QPI-1007 Injection - 1.5 mg

Treatment:

Drug: QPI-1007 Injection - 1.5 mg

single or multiple dose

Active Comparator group

Description:

QPI-1007 Injection - 3.0 mg

Treatment:

Drug: QPI-1007 Injection - 3.0 mg

Sham

Sham Comparator group

Description:

Sham injection procedure

Treatment:

Other: Sham Injection Procedure