Clinical trial NCT00856635: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Optic Neuritis
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2009-03-06
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Retinal Nerve Fiber Layer Thickness at Baseline and Month 6
timeFrame: Baseline and Month 6
Secondary outcomes:
measure: To Evaluate Changes on Additional OCT Parameters and Other Visual Function and Clinical Parameters.
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Roosevelt Hospital
name: Mark J. Kupersmith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: John Hopkins School of Medicine
name: Peter Calabresi, MD
role: PRINCIPAL_INVESTIGATOR
References: