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)
Condition: Optic Neuritis
MeSH terms: Neuritis; Optic Neuritis
Intervention: Glatiramer Acetate; placebo
Intervention description: 20 mg injected daily subcutaneously; injected daily subcutaneously
Intervention MeSH terms: Glatiramer Acetate; (T,G)-A-L
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

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 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