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

NCT01936129 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2013-09-06

No results posted yet for this study

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.

Conditions

  • Glaucoma, Angle-closure, Primary, Acute

Interventions

DRUG

Copaxone

DRUG

Placebo (buffered normal saline w/v)

Sponsors & Collaborators

  • Singapore Eye Research Institute

    lead OTHER

Principal Investigators

  • Tin Aung, FRCOphth,PhD · Singapore National Eye Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-10-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01936129 on ClinicalTrials.gov