Clinical Trial: 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)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 (AP

Brief Summary: 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.

Detailed Summary:

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).


Sponsor: Quark Pharmaceuticals

Current Primary Outcome:

  • 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

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 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 [ Time Frame: 4 months after injection ]
    • Difference between QPI-1007 and control group (sham) as assessed by change in the mean deviation compared to baseline [ Time Frame: 4 months after injection ]
    • Difference between QPI-1007 and control group (sham) as assessed by progression of the visual fields compared to baseline [ Time Frame: 4 months after injection ]
    • Difference between QPI-1007 and control group (sham) as assessed by change in the mean BCVA using the EDTRS chart compared to baseline [ Time Frame: 4 months after injection ]
    • Difference between QPI-1007 and control group (sham) as assessed by SD-OCT parameters [ Time Frame: 4 months after injection ]
    • Difference between QPI-1007 and control group (sham) as assessed by change in the mean contrast sensitivity compared to baseline [ Time Frame: 4 months after injection ]


    Original Secondary Outcome: Same as current

    Information By: Quark Pharmaceuticals

    Dates:
    Date Received: September 11, 2013
    Date Started: December 2013
    Date Completion:
    Last Updated: April 6, 2017
    Last Verified: April 2017