A Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Effects of Glatiramer Acetate (GA) on the Retinal Nerve Fiber Layer (RNFL) and Visual Function in Patients With a First Episode of Acute Optic Neuritis (AON). (Octagon)

What Was Tested

The trial (phase 3) is built around Glatiramer Acetate.

It had two arms (groups): Glatiramer acetate (experimental) and Placebo (placebo comparator).

Participants received placebo subcutaneous injection once a day for up to 6 months.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 44 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: Age: 18 - 45 years. Isolated, unilateral, first acute optic neuritis (AON) event consistent with inflammatory demyelinization, not explained by other etiologies. Onset of AON is defined by the presentation of visual disturbances. Able to provide written informed consent prior to enrollment. Willing and able to comply with the protocol requirements for the duration of the study. For women of child bearing potential:.

The full record lists 8 inclusion and 20 exclusion criteria; among the exclusions: A diagnosis of clinically definite multiple sclerosis (MS) (Clinically Definite Multiple Sclerosis); current use of any approved disease modifying agents for treatment of ms; prior clinical episode of optic neuritis in either eye.

How the Study Was Run

Design: randomized, parallel-group and triple-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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 and investigator.

It started in 2009-02 with completion listed for 2010-12.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Retinal Nerve Fiber Layer Thickness at Baseline and Month 6 (time frame: Baseline and Month 6).

It also tracked 1 secondary outcome, for example To Evaluate Changes on Additional OCT Parameters and Other Visual Function and Clinical Parameters.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glatiramer Acetate in 44 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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