Clinical Trial: 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)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief Summary: The main objective of the study is to determine whether glatiramer acetate 20 mg once daily reduces the amount of axonal loss in the optic nerve after a first event of acute optic neuritis compared to placebo patients and to generate data supporting the potential neuroprotective effect of glatiramer acetate in a human in vivo model of axonal loss.

Detailed Summary:
Sponsor: Teva Pharmaceutical Industries

Current Primary Outcome: Retinal Nerve Fiber Layer Thickness at Baseline and Month 6 [ Time Frame: Baseline and Month 6 ]

Axonal loss in the optic nerve (due to optic neuritis) was assessed by measuring retinal nerve fiber thickness of the affected eye using optical coherence tomography (OCT) at Baseline and Month 6.


Original Primary Outcome: Change in the mean RNFL (all sectors) in the affected eye from 0-6 months, in the Glatiramer Acetate vs. placebo assessed as the outcome RNFL adjusted for the baseline RNFL of the unaffected eye. [ Time Frame: 6 months ]

Current Secondary Outcome: To Evaluate Changes on Additional OCT Parameters and Other Visual Function and Clinical Parameters. [ Time Frame: 6 months ]

Original Secondary Outcome: Same as current

Information By: Teva Pharmaceutical Industries

Dates:
Date Received: March 4, 2009
Date Started: February 2009
Date Completion:
Last Updated: September 20, 2013
Last Verified: September 2013