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)

Exclusion Criteria

• •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
• •Bilateral AON
• •Inability to undergo study evaluations in both eyes
• •Known ocular or neurological conditions or abnormalities other than refractive error that impair visual function
• •Retrogeniculate visual loss
• •Refractive error of greater than +6 or -6 diopters
• •Neuromyelitis Optica (Devic's disease)
• •Systemic diseases that cause inflammatory optic neuropathy, including but not limited to Sarcoidosis, Systemic lupus erythematosus (SLE), Wegener's Granulomatosis, Syphilis, human immunodeficiency virus (HIV)
• •Known ocular conditions that preclude dilation
• •Any condition that may interfere with performance of Optical Coherence Tomography (OCT): corneal, lens or fundoscopic abnormality, a co-morbid ocular condition not related to optic neuritis as detected on the OCT reading
• •Any condition that precludes administration of Glatiramer Acetate, such as a known history of sensitivity to mannitol
• •Diabetes Mellitus Types I or II
• •Gastric bypass surgery
• •Current use of chemotherapy or radiotherapy
• •Treatments that may cause visual loss such as plaquenil, anti-tubercular agents, interferon (IFN)-alpha therapy, monoclonal antibodies Cardiac medications that may affect visual evaluations such as digitalis, amiodarone, quinine
• •Ongoing treatment with steroids (for longer than 10 days) within the last 3 months
• •Significant or unstable medical, systemic, psychiatric or logistical condition that affects the patient's ability to give informed consent or to complete the study procedures
• •Use of an investigational drug within 30 days prior to randomization