Status:
COMPLETED
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)
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Optic Neuritis
Eligibility:
All Genders
18-45 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00856635
Start Date
February 1 2009
End Date
February 1 2011
Last Update
February 6 2018
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