Optiquel® as Corticosteroid-sparing Therapy for Chronic Noninfectious Uveitis
Status:
Completed
Trial end date:
2014-02-01
Target enrollment:
Participant gender:
Summary
Background:
Uveitis is a serious inflammatory condition in which the body's immune system attacks parts
of the eye, often causing vision loss. Uveitis treatments involve various drugs that suppress
the immune system, but these medicines sometimes do not work or may cause serious side
effects. Researchers are interested in developing new treatments for uveitis that are more
effective and have fewer side effects.
Optiquel® is an experimental medication being tested for its effectiveness against uveitis.
It contains B27PD, a small protein fragment, which is similar to proteins in the parts of the
eye being attacked by the immune system. Taking Optiquel® (B27PD) by mouth may induce oral
tolerance, in which the immune system is taught to recognize and not attack normal parts of
the human body.
Objectives:
To evaluate the safety and effectiveness of B27PD (Optiquel®) as a treatment for uveitis.
Eligibility:
Individuals at least 18 years of age who have had noninfectious uveitis in one or both eyes
for at least 3 months, have vision of 20/200 or better in at least one eye, and are taking
daily prednisone or an equivalent medication.
Design:
Participants will be screened with a physical examination, medical history, blood and urine
tests, and an eye exam.
This study will last a maximum of 52 weeks. During the first 12 weeks of the study,
participants will have a study visit every 2 weeks. For the remainder of the study,
participants will have a study visit every 4 weeks.
Participants will have frequent blood and urine tests, and will also have eye examinations
and special procedures (fluorescein angiography and indocyanine green angiography) to
evaluate the effectiveness of the treatment.
Participants will be randomly assigned into one of three groups and will receive either one
of two different doses of B27PD or a placebo. During the study, participants will also have
their dose of prednisone or other steroid medication reduced.
Participants will take one capsule three times per week on Monday, Wednesday, and Friday, for
a total of 24 weeks. Participants may take the capsule with water, but should not consume any
other drinks or any kind of food until at least 30 minutes have passed to prevent stomach
upset. The capsules should be stored in the refrigerator.