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)

NCT ID: NCT00856635

Last Updated: 2018-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2011-02-28

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.

Conditions

Optic Neuritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Glatiramer acetate

Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.

Group Type: EXPERIMENTAL

Glatiramer Acetate

Intervention Type: DRUG

20 mg injected daily subcutaneously

Placebo

Participants received placebo subcutaneous injection once a day for up to 6 months.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

injected daily subcutaneously

Interventions

Glatiramer Acetate

20 mg injected daily subcutaneously

Intervention Type: DRUG

placebo

injected daily subcutaneously

Intervention Type: DRUG

Other Intervention Names

Copaxone

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark J. Kupersmith, MD

Role: PRINCIPAL_INVESTIGATOR

Roosevelt Hospital

Peter Calabresi, MD

Role: PRINCIPAL_INVESTIGATOR

John Hopkins School of Medicine

Other Identifiers

PM030

Identifier Type: -

Identifier Source: org_study_id