Phase IIA Double-Masked Randomized Sham-Controlled Trial of QPI-1007 Delivered by a Single Intravitreal Injection to Subjects With Acute Primary Angle-Closure Glaucoma (APACG)

Phase 2CompletedNCT01965106

Quark Pharmaceuticals46 enrolled

Overview

This study will assess any side effects that may occur when QPI-1007 is injected into the eye in subjects with acute primary angle-closure glaucoma, as well as how long it takes for the body to clear the drug. This study will also test whether QPI-1007, injected into the eye, helps prevent both structural damage of the nerve tissue in the eye and the loss of visual function in subjects with acute primary angle-closure glaucoma.

This is a Phase IIa double-masked, single dose, randomized, sham-controlled study evaluating the safety and tolerability, and pharmacokinetics of QPI-1007 versus Control (sham procedure) in subjects with an acute attack of primary angle-closure glaucoma. Subjects will be randomized at a ratio of 1:1 into one of two study arms: 1.5 QPI-1007 arm or Control arm (sham procedure). The study will enroll approximately 30 subjects into each arm. Randomization will be stratified by time from symptom onset to the study drug administration or sham procedure (≤72 hours and \>72 hours).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Glaucoma, Angle-closure, Primary, Acute

Interventions

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males and females aged at least 40 years or older. * Onset of symptoms of an acute attack of primary angle-closure in the study eye within the 120 hours prior to the planned study drug administration. * Best-corrected visual acuity (BCVA) 20/40 or better in the study eye after resolution of the acute attack. * Received successful treatment for the acute attack of angle-closure, and have undergone laser iridotomy with intraocular pressure in the study eye \<25mm Hg. * Sufficiently clear ocular media and adequate pupil dilation to allow the optic nerve and fovea to be visualized and assessed in the study eye. * Female subjects must be: (1) post menopausal, (2) surgically sterile, or (3) using an effective means of contraception. Exclusion Criteria: * Previously diagnosed with glaucoma in either eye. * The time planned for study drug administration is more than 120 hours from the onset of the symptoms. * History of chronic angle-closure in either eye. * Secondary angle-closure/secondary angle-closure glaucoma in the study eye. * Monocular subjects. * Prior incisional intraocular surgery. * Inability to perform a reliable visual field test on Day 0 in the study eye. * History of panretinal photocoagulation or macular laser photocoagulation in the study eye. * History of active malignancy within the last 5 years (however, non facial, basal cell carcinoma is allowed). * History of myocardial infarction within the last 6 months. * Received any drugs known to cause optic nerve or retinal toxicity within 14 days prior to dosing. * Women who are pregnant or lactating. * Participating in a concurrent interventional study with the last intervention occurring within 30 days prior to planned dosing with QPI-1007.

Locations (8)

The Gavin Herbert Eye Institute, UC Irvine

Orange, California, United States

Doheny Eye Center, UCLA

Pasadena, California, United States

Robert Cizik Eye Clinic - Clinical Trials Unit

Houston, Texas, United States

Dept. of Ophthalmology, University of Washington Medical Center

Seattle, Washington, United States

Singapore National Eye Centre

Singapore, Singapore

Hanoi Eye Hospital

Hà Nội, Vietnam

Vietnam National Institute of Ophthalmology

Hà Nội, Vietnam

Ho Chi Minh City Eye Hospital

Ho Chi Minh City, Vietnam

Outcomes

Primary Outcomes

Safety and tolerability of a single intravitreal (IVT) dose of QPI-1007 as assessed by adverse events (AE)

Time frame: Day 0 (after injection) through Month 4. Systemic serious AEs (SAEs) assessed as related to study drug and all ocular SAEs Month 4 to Month 6 after injection

Safety and tolerability of a single IVT dose of QPI-1007 as assessed by laboratory evaluations

Time frame: Screening, Day 1, and Month 4 after injection

Safety and tolerability of a single IVT dose of QPI-1007 as assessed by vital signs and weight

Time frame: Weight: Screening and Month 4; Vital signs: Screening, Days 0 (before injection), 1 and 7, and Month 4 to 6

Safety and tolerability of a single IVT dose of QPI-1007 as assessed by ophthalmic evaluations, Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (EDTRS) chart and slit lamp exams (anterior & posterior segment)

Time frame: Screening, Days 0, 1 and 7, and Month 1 to 6

Safety and tolerability of a single IVT dose of QPI-1007 as assessed by ophthalmic evaluations, Visual Field (VF) and Spectral Domain Optical Coherence Tomography (SD-OCT)

Time frame: Days 0 and 7, and Month 1 to 6

Safety and tolerability of a single IVT dose of QPI-1007 as assessed by ophthalmic evaluation intraocular pressure (IOP)

Time frame: Screening, Days 0 (before injection, both eyes; after injection study eye only), 1 and 7, and Month 1 to 6

Safety and tolerability of a single IVT dose of QPI-1007 as assessed by ophthalmic evaluation, Fundus Photographs (FP)

Time frame: Days 0 and 7, and Month 4

Safety and tolerability of a single IVT dose of QPI-1007 as assessed by ophthalmic evaluations optic nerve head stereo photographs and contrast sensitivity

Time frame: Days 0 and 7, and Month 4 and 6

Safety and tolerability of a single IVT dose of QPI-1007 as assessed by use of concomitant treatments

Time frame: Days 0, 1 and 7, and Month 1 to 6

Secondary Outcomes

QPI-1007 pharmacokinetics (PK) parameters as assessed by the peak plasma concentration (Cmax)

Time frame: Pre-injection, 1, 4 and 24 hours after injection, and 7 days after injection

QPI-1007 pharmacokinetics (PK) parameters as assessed by the time to peak plasma concentration (Tmax)

Time frame: Pre-injection, 1, 4 and 24 hours after injection, and 7 days after injection

Difference between QPI-1007 and control group (sham) as assessed by the prevalence of the abnormal visual fields