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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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)

NCT00856635•Teva Branded Pharmaceutical Products R&D, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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:
•* A negative urine pregnancy test o
•* Willing to practice an acceptable method of birth control •
•Willing to receive a steroidal regimen

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)
+10 more criteria

Key Dates

Start Date

February 1, 2009

Primary Completion Date

December 1, 2010

Completion Date

February 1, 2011

Last Updated

February 6, 2018

Enrollment

ACTUAL participants

Conditions

Optic Neuritis

Interventions

Glatiramer Acetate

DRUG

placebo

DRUG

Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)

NCT07100990

Optic NeuritisMyelitis+1 more

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RECRUITINGPHASE2

Efgartigimod for the Treatment of Acute Optic Neuritis

NCT06453694

Optic Neuritis

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)

Efgartigimod for the Treatment of Acute Optic Neuritis

Retinal Neuro-vascular Coupling in Patients With Multiple Sclerosis

Visual (Path)Ways in Multiple Sclerosis - Part II

Light Stimulation to Improve Visual Function After Optic Neuritis in Persons with Multiple Sclerosis

The Longitudinal CONQUER Study of Rare Neuroimmunologic Disorders