- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01965106
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Singapore, Singapore, 168751
- Singapore National Eye Centre
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California
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Orange, California, United States, 92868
- The Gavin Herbert Eye Institute, UC Irvine
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Pasadena, California, United States, 91105
- Doheny Eye Center, UCLA
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Texas
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Houston, Texas, United States, 77030
- Robert Cizik Eye Clinic - Clinical Trials Unit
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Washington
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Seattle, Washington, United States, 98104
- Dept. of Ophthalmology, University of Washington Medical Center
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Ha Noi, Vietnam
- Hanoi Eye Hospital
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Ha Noi, Vietnam
- Vietnam National Institute of Ophthalmology
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Ho Chi Minh City, Vietnam
- Ho Chi Minh City Eye Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: QPI-1007 Injection
single intravitreal (IVT) injection of QPI-1007
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1.5 mg QPI-1007 Injection
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Sham Comparator: Control
Placebo (Sham injection procedure)
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Sham injection procedure
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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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
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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
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Screening, Day 1, and Month 4 after injection
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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
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Weight: Screening and Month 4; Vital signs: Screening, Days 0 (before injection), 1 and 7, and Month 4 to 6
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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
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Screening, Days 0, 1 and 7, and Month 1 to 6
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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
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Days 0 and 7, and Month 1 to 6
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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
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Screening, Days 0 (before injection, both eyes; after injection study eye only), 1 and 7, and Month 1 to 6
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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
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Days 0 and 7, and Month 4
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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
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Days 0 and 7, and Month 4 and 6
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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
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Days 0, 1 and 7, and Month 1 to 6
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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
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Pre-injection, 1, 4 and 24 hours after injection, and 7 days after injection
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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
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Pre-injection, 1, 4 and 24 hours after injection, and 7 days after injection
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Difference between QPI-1007 and control group (sham) as assessed by the prevalence of the abnormal visual fields
Time Frame: 4 months after injection
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4 months after injection
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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
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4 months after injection
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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
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4 months after injection
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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
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4 months after injection
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Difference between QPI-1007 and control group (sham) as assessed by SD-OCT parameters
Time Frame: 4 months after injection
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4 months after injection
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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
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4 months after injection
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Avner Ingerman, M.D., MSc., Quark Pharmaceuticals
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- QRK208
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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