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Acute Optic Neuritis Treatment Trial
O.C.T.A.G.O.N. - TEVA Neuroscience
Acute Optic Neuritis (AON) affects about 3 patients per 100,000 in the United States. Currently there are no options for their treatment other than steroid administration. Dr. Rosa Tang, MD is a principal investigator for a research study evaluating the clinical effectiveness and safety of Copaxone®, once daily injection, for patients with a first episode of AON.
The OCTAGON study is a multi-center, randomized double-blind, placebo-controlled trial that is being conducted within the United States. We are currently enrolling participants in this study and these patients will receive standard of care therapy, plus Copaxone once daily or placebo. All trial related costs will be covered by the Sponsor, Teva Neuroscience.
We are the only site in Texas enrolling for this study!!
Pre-Enrollment Period:
( 0 - 9 days post acute optic neuritis )
Patients will be allowed to enroll within 9 days following the acute optic neuritis event manifested by visual disturbances. The patient will undergo the clinic's customary workup free of charge. Patients must be enrolled in less than 9 days following visual loss.
Inclusion Criteria:
Patients must meet all criteria to be eligible for the study:
- 18-45 years of age
- Isolated, unilateral, first acute optic neuritis event onset defined by visual disturbances
- Able to provide written informed consent prior to enrollment
- Willing and able to comply with protocol requirements for the six-month study duration
- Willing to receive steroidal regimen
- For women of child-bearing age:
- negative pregnancy test
- willing to practice an acceptable method of birth control
Exclusion Criteria:
- Multiple Sclerosis Diagnosis
- Current use of any approved disease-modifying agents for treatment of Multiple Sclerosis
- Prior clinical episode of optic neuritis in either eye
- Bilateral acute optic neuritis
- Inability to undergo study evaluations in both eyes
- Known ocular or neurological conditions or abnormalities
- Retrogeniculate visual loss
- Refrative error of greater than +6 or -6
- Neuromyelitis Optica (Devic's Disease)
- Systemic diseases that cause inflammatory optic neuropathy, including but not limited to Sarcoidosis, SLE, Wegener's, Granulomatosis, Syphilis and HIV
- Patients that cannot be dilated
- Any condition that precludes administration of Glatiramer Acetate, such as known history of sensitivity to mannitol
- Diabetes
- Gastric Bypass Surgery
- Current use of chemotherapy or radiotherapy
- Treatments that may cause visual loss such as plaquenil, anti-tubercular agents, IFN-alpha therapy or monoclonal antibodies
- Cardiac medications that may affect visual evaluations such as digitalis, amiodarone and quinine
- Unwilling or unable to receive short-term steroidal regimen
- Ongoing treatment with steroids (for longer than 10 days)
- Immunosuppressive conditions
- Organ transplant
- Tuberculosis
- Conditions that require rheumatologic agents or biologics
- Significant or unstable medical, systemic, psychiatric or logistical condition that affects the subjects ability to give informed consent or to complete the study procedures
- Use of an investigational drug within 30 days prior to randomization
Please send your patients to:
Dr. Rosa Tang, MD, MPH, MBA
MS Eye Care at The University Eye Institute
4901 Calhoun Rd, UH Entrance 2
Houston, Texas 77204
Phone: 713-942-2187
Fax: 713-942-0265
Call to schedule an appointment or download this form and fax it to us!
(please write OCTAGON under referral reason)
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