This study examined the safety and potential efficacy of the monoclonal antibody efalizumab
(Raptiva) for treating sight-threatening uveitis (eye inflammation). Efalizumab controls the
activity of white blood cells called lymphocytes that cause inflammation. The drug is
currently approved in the United States to treat patients with moderate to severe psoriasis.
Participants 18 and older with sight-threatening intermediate or posterior uveitis of at
least 3 months duration, causing persistent macular edema in one or both eyes, were eligible
for this study. The uveitis required treatment with at least 20 milligrams per day of
prednisone, or the equivalent, or a combination of two or more anti-inflammatory treatments
such as prednisone, methotrexate, cyclophosphamide, cyclosporine, etc.
Participants underwent the following tests and procedures:
- Medical history and physical examination.
- Weekly efalizumab treatment.
- Weekly eye examination, including measurement of vision and pressure in the eyes,
dilation of the eyes and examination of the front and back parts of the eye.
- Weekly blood tests to measure the number and types of cells in the blood and to check
for signs of inflammation and treatment side effects. At some visits, blood samples were
collected to measure how much efalizumab remains in the blood and whether the body has
developed an immune response to the medicine.
- Blood draw at enrollment and at 2 and 4 months for research tests to examine how
participants' immune response was operating.
- Fluorescein angiography at enrollment and 1 and 3 months after enrollment, unless
additional tests are needed, for medical management. This test checked for abnormalities
of eye blood vessels. A yellow dye was injected into an arm vein and travels to the
blood vessels in the eyes. Pictures of the retina (the back portion of the eye) were
taken with a special camera that flashes a blue light into the eye. The pictures show
whether any dye has leaked from the vessels into the retina, indicating possible
abnormalities.
- Monthly pregnancy test for women who could become pregnant.
Participants returned for treatment and clinic visits weekly for 16 weeks. After 16 weeks,
participants whose macular edema had decreased and whose vision may have improved were
offered to continue the injections.