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)

NCT01965106 | Completed Phase 2

• 1 other identifier: QRK208
• Study Type: interventional
• Target: 46
• Locations: 3 countries
• Sites: 8

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.

Conditions

Glaucoma, Angle-closure, Primary, Acute

Keywords

Glaucoma, Angle-Closure; Glaucoma, Closed-Angle; Primary angle closure; Acute angle closure; Acute angle-closure glaucoma

Outcome Measures

Primary Outcomes (9)

• 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

• 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

Secondary Outcomes (8)

• 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)

  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

Study Arms (2)

QPI-1007 Injection

ACTIVE COMPARATOR

single intravitreal (IVT) injection of QPI-1007

Drug: QPI-1007 Injection

Control

SHAM COMPARATOR

Placebo (Sham injection procedure)

Drug: (including placebo)

Interventions

QPI-1007 Injection DRUG

1.5 mg QPI-1007 Injection

QPI-1007 Injection

(including placebo) DRUG

Sham injection procedure

Control

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Quark Pharmaceuticals: lead

Study Sites (8)

The Gavin Herbert Eye Institute, UC Irvine

Orange, California, 92868, United States

Location

Doheny Eye Center, UCLA

Pasadena, California, 91105, United States

Location

Robert Cizik Eye Clinic - Clinical Trials Unit

Houston, Texas, 77030, United States

Location

Dept. of Ophthalmology, University of Washington Medical Center

Seattle, Washington, 98104, United States

Location

Singapore National Eye Centre

Singapore, 168751, Singapore

Location

Hanoi Eye Hospital

Hà Nội, Vietnam

Location

Vietnam National Institute of Ophthalmology

Hà Nội, Vietnam

Location

Ho Chi Minh City Eye Hospital

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Glaucoma; Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Avner Ingerman, M.D., MSc.

  Quark Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2013
• First Posted: October 18, 2013
• Study Start: December 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: April 7, 2017

Record last verified: 2017-04

Locations

SG (1); US (4); VN (3)