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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-07-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Glaucoma, Angle-closure, Primary, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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QPI-1007 Injection

single intravitreal (IVT) injection of QPI-1007

Group Type ACTIVE_COMPARATOR

QPI-1007 Injection

Intervention Type DRUG

1.5 mg QPI-1007 Injection

Control

Placebo (Sham injection procedure)

Group Type SHAM_COMPARATOR

(including placebo)

Intervention Type DRUG

Sham injection procedure

Interventions

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QPI-1007 Injection

1.5 mg QPI-1007 Injection

Intervention Type DRUG

(including placebo)

Sham injection procedure

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No