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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)

Primary Purpose

Glaucoma, Angle-closure, Primary, Acute

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

QPI-1007 Injection

(including placebo)

About this trial

This is an interventional other trial for Glaucoma, Angle-closure, Primary, Acute focused on measuring Glaucoma, Angle-Closure, Glaucoma, Closed-Angle, Primary angle closure, Acute angle closure, Acute angle-closure glaucoma

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The Gavin Herbert Eye Institute, UC Irvine
Doheny Eye Center, UCLA
Robert Cizik Eye Clinic - Clinical Trials Unit
Dept. of Ophthalmology, University of Washington Medical Center
Singapore National Eye Centre
Hanoi Eye Hospital
Vietnam National Institute of Ophthalmology
Ho Chi Minh City Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

QPI-1007 Injection

Control

Arm Description

single intravitreal (IVT) injection of QPI-1007

Placebo (Sham injection procedure)

Outcomes

Primary Outcome Measures

Safety and tolerability of a single intravitreal (IVT) dose of QPI-1007 as assessed by adverse events (AE)

Safety and tolerability of a single IVT dose of QPI-1007 as assessed by laboratory evaluations

Safety and tolerability of a single IVT dose of QPI-1007 as assessed by vital signs and weight

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)

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)

Safety and tolerability of a single IVT dose of QPI-1007 as assessed by ophthalmic evaluation intraocular pressure (IOP)

Safety and tolerability of a single IVT dose of QPI-1007 as assessed by ophthalmic evaluation, Fundus Photographs (FP)

Safety and tolerability of a single IVT dose of QPI-1007 as assessed by ophthalmic evaluations optic nerve head stereo photographs and contrast sensitivity

Safety and tolerability of a single IVT dose of QPI-1007 as assessed by use of concomitant treatments

Secondary Outcome Measures

QPI-1007 pharmacokinetics (PK) parameters as assessed by the peak plasma concentration (Cmax)

QPI-1007 pharmacokinetics (PK) parameters as assessed by the time to peak plasma concentration (Tmax)

Difference between QPI-1007 and control group (sham) as assessed by the prevalence of the abnormal visual fields

Difference between QPI-1007 and control group (sham) as assessed by change in the mean deviation compared to baseline

Difference between QPI-1007 and control group (sham) as assessed by progression of the visual fields compared to baseline

Difference between QPI-1007 and control group (sham) as assessed by change in the mean BCVA using the EDTRS chart compared to baseline

Difference between QPI-1007 and control group (sham) as assessed by SD-OCT parameters

Difference between QPI-1007 and control group (sham) as assessed by change in the mean contrast sensitivity compared to baseline

Full Information

NCT ID

NCT01965106

First Posted

September 11, 2013

Last Updated

April 6, 2017

Sponsor

Quark Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01965106

Brief 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 (APACG)

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 (APACG)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

December 2013 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Quark Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Angle-closure, Primary, Acute

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

QPI-1007 Injection

Arm Type

Active Comparator

Arm Description

single intravitreal (IVT) injection of QPI-1007

Arm Title

Control

Arm Type

Sham Comparator

Arm Description

Placebo (Sham injection procedure)

Intervention Type

Drug

Intervention Name(s)

QPI-1007 Injection

Intervention Description

1.5 mg QPI-1007 Injection

Intervention Type

Drug

Intervention Name(s)

(including placebo)

Intervention Description

Sham injection procedure

Primary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

Time Frame

Screening, Days 0, 1 and 7, and Month 1 to 6

Title

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

Title

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

Title

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

Title

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

Title

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

Secondary Outcome Measure Information:

Title

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

Title

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

Title

Difference between QPI-1007 and control group (sham) as assessed by the prevalence of the abnormal visual fields

Time Frame

4 months after injection

Title

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

Title

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

Title

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

Title

Difference between QPI-1007 and control group (sham) as assessed by SD-OCT parameters

Time Frame

4 months after injection

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Avner Ingerman, M.D., MSc.

Organizational Affiliation

Quark Pharmaceuticals

Official's Role

Study Chair

Facility Information:

Facility Name

The Gavin Herbert Eye Institute, UC Irvine

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Doheny Eye Center, UCLA

City

Pasadena

State/Province

California

ZIP/Postal Code

91105

Country

United States

Facility Name

Robert Cizik Eye Clinic - Clinical Trials Unit

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Dept. of Ophthalmology, University of Washington Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

Singapore National Eye Centre

City

Singapore

ZIP/Postal Code

168751

Country

Singapore

Facility Name

Hanoi Eye Hospital

City

Ha Noi

Country

Vietnam

Facility Name

Vietnam National Institute of Ophthalmology

City

Ha Noi

Country

Vietnam

Facility Name

Ho Chi Minh City Eye Hospital

City

Ho Chi Minh City

Country

Vietnam

12. IPD Sharing Statement

Learn more about this 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)

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