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)

Phase 3

Completed

Conditions: Optic Neuritis

Interventions: Drug: Glatiramer Acetate
Drug: placebo

Registration Number: NCT00856635

Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

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 Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 44

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)
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glatiramer acetate	Glatiramer Acetate	Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
Placebo	placebo	Participants received placebo subcutaneous injection once a day for up to 6 months.

Primary Outcome Measures

Name	Time	Method
Retinal Nerve Fiber Layer Thickness at Baseline and Month 6	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.

Secondary Outcome Measures