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)

Completed · Phase 2 · Has a placebo group

Conditions studied: Glaucoma, Angle-closure, Primary, Acute

In brief

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.

Key facts

Study ID

NCT01965106

Run by

Quark Pharmaceuticals

People needed

46

Starts

2013-12-01

Expected to finish

2015-07-01

Last updated by the study team

2017-04-07

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• The Gavin Herbert Eye Institute, UC Irvine — Orange, California, United States
• Doheny Eye Center, UCLA — Pasadena, California, United States
• Robert Cizik Eye Clinic - Clinical Trials Unit — Houston, Texas, United States
• Dept. of Ophthalmology, University of Washington Medical Center — Seattle, Washington, United States
• Singapore National Eye Centre — Singapore, Singapore
• Hanoi Eye Hospital — Hà Nội, Vietnam
• Vietnam National Institute of Ophthalmology — Hà Nội, Vietnam
• Ho Chi Minh City Eye Hospital — Ho Chi Minh City, Vietnam

Full record on ClinicalTrials.gov

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