drugset / Trial / NCT01936129

Investigating the Neuroprotective Effect of Cop-1 (Copaxone) in Acute Primary Angle Closure

NCT01936129

Phase 3 Unknown 196 enrolled Singapore Eye Research Institute
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This is a randomised controlled trial to assess the neuroprotective effect of Cop-1 (Copaxone) in patients with acute primary angle closure (APAC). The standardized management of APAC will include medical therapy to reduce intraocular pressure (IOP), followed by laser peripheral iridotomy. Cop-1 will be administered in addition to standard therapy as a subcutaneous dose once within 24 hours of presentation, and then one week later (total 2 injections). The control group will have placebo in addition to standard regimen. Subjects in the study will have visual field test performed with the Humphrey Visual Field Analyzer II, retinal nerve fibre layer (RNFL) thickness measured with the Stratus optical coherence tomography (OCT) and Optic nerve head evaluated with the Heidelberg retinal tomography (HRT). At least 2 baseline visual field tests will also be performed in the first week. Subsequent visits will be at week 4, 8, 12 and 16. The outcome criteria will be difference in visual field, RNFL thickness, and optic nerve head structural changes.

Timeline

Start
2010-09
Primary completion
2013-10
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Glatiramer Acetate Small molecule 20 mg Subcutaneous