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)

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)

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.

Study Overview

• Status: Completed
• Conditions: Optic Neuritis
• Intervention / Treatment: Drug: Glatiramer Acetate; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glatiramer acetate; Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.	Drug: Glatiramer Acetate; 20 mg injected daily subcutaneously; Other Names: Copaxone
Placebo Comparator: Placebo; Participants received placebo subcutaneous injection once a day for up to 6 months.	Drug: placebo; injected daily subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retinal Nerve Fiber Layer Thickness at 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.	Baseline and Month 6

Secondary Outcome Measures

Outcome Measure	Time Frame
To Evaluate Changes on Additional OCT Parameters and Other Visual Function and Clinical Parameters.	6 months

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Investigators: Principal Investigator: Mark J. Kupersmith, MD, Roosevelt hospital; Principal Investigator: Peter Calabresi, MD, John Hopkins School of Medicine

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: March 4, 2009
• First Submitted That Met QC Criteria: March 5, 2009
• First Posted (Estimate): March 6, 2009

Study Record Updates

• Last Update Posted (Actual): February 6, 2018
• Last Update Submitted That Met QC Criteria: January 8, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Neuritis; Optic Neuritis; Physiological Effects of Drugs; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Adjuvants, Immunologic; Glatiramer Acetate; (T,G)-A-L
• Other Study ID Numbers: PM030