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
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Quark Pharmaceuticals

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.