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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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Quark Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Quark Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01965106
First received: September 11, 2013
Last updated: September 9, 2014
Last verified: May 2014

September 11, 2013
September 9, 2014
December 2013
December 2014   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01965106 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Difference between QPI-1007 and control group (sham) as assessed by the prevalence of the abnormal visual fields [ Time Frame: 4 months after injection ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Difference between QPI-1007 and control group (sham) as assessed by SD-OCT parameters [ Time Frame: 4 months after injection ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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 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)

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Glaucoma, Angle-closure, Primary, Acute
  • Drug: QPI-1007 Injection
    1.5 mg QPI-1007 Injection
  • Drug: (including placebo)
    Sham injection procedure
  • Active Comparator: QPI-1007 Injection
    single intravitreal (IVT) injection of QPI-1007
    Intervention: Drug: QPI-1007 Injection
  • Sham Comparator: Control
    Placebo (Sham injection procedure)
    Intervention: Drug: (including placebo)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
July 2015
December 2014   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact: Judith Lynn jlynn@quarkpharma.com
United States,   Singapore,   Vietnam
 
NCT01965106
QRK208
No
Quark Pharmaceuticals
Quark Pharmaceuticals
Not Provided
Study Chair: Avner Ingerman, M.D., MSc. Quark Pharmaceuticals
Quark Pharmaceuticals
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP