NCT01936129

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: Singapore Eye Research Institute · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Aim To assess the neuroprotective effect of Cop-1 (Copaxone) in reducing functional and structural damage after acute primary angle closure (APAC) Outcome measures: The primary outcome measures will be the point-wise linear regression in the visual fields. The secondary outcome measure will be the evaluation of structural changes, namely, RNFL thickness and Optic disc changes as measured by stratus OCT and HRT respectively. Study population The study population (n=196; 1:1 randomisation) will be patients with APAC attending the Singapore National Eye Centre who fulfil the inclusion criteria and are willing to take part in the study. Study design: The study design is a randomized, placebo controlled, double blinded trial where patients with APAC will be randomized to receive either Cop-1 (Copaxone) or placebo in addition to the standard medical therapy. An interim analysis will be conducted after 40 patients complete the trial. Routine examination will be done at all visits.

Conditions

• Glaucoma, Angle-closure, Primary, Acute

Interventions

Type	Name	Description
DRUG	Copaxone
DRUG	Placebo (buffered normal saline w/v)

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-10-01
• First posted: 2013-09-05
• Last updated: 2013-09-06

Locations

1 site across 1 country: Singapore