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)



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:40 - Any
Updated:4/8/2017
Start Date:December 2013
End Date:July 2015

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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).

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.
We found this trial at
5
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Houston, TX
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Orange, CA
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Pasadena, California 91105
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Pasadena, CA
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Seattle, WA
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Singapore,
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