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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QPI-1007 Injection | Active Comparator | single intravitreal (IVT) injection of QPI-1007 |
|
| Control | Sham Comparator | Placebo (Sham injection procedure) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QPI-1007 Injection | Drug | 1.5 mg QPI-1007 Injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of a single intravitreal (IVT) dose of QPI-1007 as assessed by adverse events (AE) | 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 | 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 | 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) | 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) | 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) | 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) | Days 0 and 7, and Month 4 | |
| Measure | Description | Time Frame |
|---|---|---|
| QPI-1007 pharmacokinetics (PK) parameters as assessed by the peak plasma concentration (Cmax) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Avner Ingerman, M.D., MSc. | Quark Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Gavin Herbert Eye Institute, UC Irvine | Orange | California | 92868 | United States | ||
| Doheny Eye Center, UCLA |
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| (including placebo) |
| Drug |
Sham injection procedure |
|
| Safety and tolerability of a single IVT dose of QPI-1007 as assessed by ophthalmic evaluations optic nerve head stereo photographs and contrast sensitivity |
| 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 | Days 0, 1 and 7, and Month 1 to 6 |
| 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 | 4 months after injection |
| Difference between QPI-1007 and control group (sham) as assessed by change in the mean deviation compared to baseline | 4 months after injection |
| Difference between QPI-1007 and control group (sham) as assessed by progression of the visual fields compared to baseline | 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 | 4 months after injection |
| Difference between QPI-1007 and control group (sham) as assessed by SD-OCT parameters | 4 months after injection |
| Difference between QPI-1007 and control group (sham) as assessed by change in the mean contrast sensitivity compared to baseline | 4 months after injection |
| Pasadena |
| California |
| 91105 |
| United States |
| Robert Cizik Eye Clinic - Clinical Trials Unit | Houston | Texas | 77030 | United States |
| Dept. of Ophthalmology, University of Washington Medical Center | Seattle | Washington | 98104 | United States |
| Singapore National Eye Centre | Singapore | 168751 | 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 |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D015812 | Glaucoma, Angle-Closure |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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