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 ]
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