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

What Was Tested

In this phase 3 trial, researchers set out to test Glatiramer Acetate.

This is a randomised controlled trial to assess the neuroprotective effect of Cop-1 (Copaxone) in patients with acute primary angle closure (APAC).

It had two arms (groups): Copaxone (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

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 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.

Who Took Part

196 planned participants were the target.

It was open to people of any sex aged from 21 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: • patients with APAC who present to the centre not later than 7 days from the initiation of the attack. The presence of at least two of the following symptoms: ocular or periocular pain, nausea or vomiting or both, and an antecedent history of blurring of vision with haloes;. A presenting intraocular pressure of at least 28 mm Hg on Goldmann applanation tonometry;. The presence of at least three of the following signs: conjunctival injection, corneal epithelial oedema, middilated unreactive pupil, and shallow anterior chamber;. The presence of an occludable angle in the affected eye on gonioscopy;.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: pre-existing chronic angle closure glaucoma in the eye with apac; secondary causes of angle closure like subluxed lens, uveitis, trauma and neovascular glaucoma;; corneal abnormalities, media opacities, or retinal abnormalities that would affect scanning laser polarimetry;.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this Glatiramer Acetate study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Glatiramer Acetate group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Glatiramer Acetate, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2010-09 with completion listed for 2013-10.

It ran at 1 site in Singapore.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Visual field progression using point-wise linear regression (time frame: 16 weeks).

It also tracked 1 secondary outcome, for example The secondary outcome measure will be the evaluation of structural changes of the optic nerve head.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glatiramer Acetate in 196 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glatiramer Acetate compound page, all human trials.