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)

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Pharmaceutical Industries
• Treatments: (T,G)-A-L; Glatiramer Acetate

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