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) - NCT00856635(Clinical Trial 276111)
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Milwaukee |
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State:
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WI |
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53215 |
| Conditions: |
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Optic Neuritis |
| Purpose: |
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The main objective of the study is to determine whether GA 20mg SC once daily reduces the
amount of axonal loss in the optic nerve (measured by RFNL thickness) after a first event of
AON compared to placebo patients and to generate data supporting the potential
neuroprotective effect of GA in a human in vivo model of axonal loss..
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Age: 18 - 45 years
- Isolated, unilateral, first 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 MS (CDMS)
- 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, SLE, Wegener's Granulomatosis, Syphilis, HIV
- Known ocular conditions that preclude dilation
- Any condition that may interfere with performance of 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,
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 subject's ability to give informed consent or to complete the study
procedures
- Use of an investigational drug within 30 days prior to randomization |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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September 9, 2010 |
Modifications to
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