Efficacy of Bevacizumab (Avastin) in Treatment of Acute NMO Exacerbations

Inclusion Criteria

• •Subjects eligible for enrollment must meet all of the following criteria:
• •1. Able and willing to provide written informed consent.
• •2. 18-70 years of age.
• •3. New acute optic neuritis and/or transverse myelitis. A clinical event is defined as an episode of inflammation in the spinal cord and/or optic nerve leading to neurologic symptoms not ascribed to another disease process.
• •4. Known or suspected diagnosis of NMO according to the 2006 revisions of the Wingerchuk diagnostic criteria for NMO or AQP4 positive NMOSD per the EFNS Guidelines. For NMO, subjects must have two absolute criteria:
• •1. optic neuritis
• •2. myelitis and at least two of three supportive criteria:
• •3. presence of a contiguous spinal cord MRI lesion extending over three or more vertebral segments,
• •4. MRI criteria NOT satisfying the revised McDonald diagnostic criteria for MS \[Polman, 2011\]
• •5. NMO-IgG (AQP4) in serum. For NMOSD, subjects must have longitudinally extensive transverse myelitis (LETM) recurrent isolated optic neuritis (RION)/bilateral optic neuritis (BON), or opticospinal multiple sclerosis (OSMS) that is AQP4 antibody positive
• •5. A female subject is eligible to enter the study if she is:
• •A. Not pregnant or nursing; B. Of non-childbearing potential (i.e. women who have had a hysterectomy, are postmenopausal, which is defined as \>2 years without menses (female subjects who have been post-menopausal for \<2 years must be confirmed with Follicle Stimulating Hormone (FSH) and estradiol levels), have both ovaries surgically removed or have current documented tubal ligation); or,
• •C. Of childbearing potential (i.e. women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea (even severe), women who are perimenopausal or have just begun to menstruate. The subject must have a negative serum pregnancy test at screening and agrees to one of the following:
• •i. Complete abstinence from intercourse for the period from consent into the study until 6 months after the last dose of investigational product; or, ii. Consistent and correct use of one of the following acceptable methods of birth control for the period from consent into the study until 6 months after the last dose of investigational product:
• •1. Oral contraceptives (either combined or progesterone only)
• •2. Injectable progesterone
• •3. Levonorgestrel implants
• •4. Estrogenic vaginal ring
• •5. Percutaneous contraceptive patches
• •6. Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of \<1% per year
• •7. Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study; this male must be the sole partner for the subject
• •8. Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository).