NCT01965106

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Quark Pharmaceuticals · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Glaucoma, Angle-closure, Primary, Acute

Interventions

Type	Name	Description
DRUG	QPI-1007 Injection	1.5 mg QPI-1007 Injection
DRUG	(including placebo)	Sham injection procedure

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-06-01
• Completion: 2015-07-01
• First posted: 2013-10-18
• Last updated: 2017-04-07

Locations

8 sites across 3 countries: United States, Singapore, Vietnam