Uveitis Clinical Trial
Official title:
Peptide B27PD (Optiquel®) as Corticosteroid-sparing Therapy for Chronic Non-infectious Uveitis (BOOTS)
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.
Objective: The objective of this study is to evaluate the safety and efficacy of the peptide
B27PD (Optiquel®) as a corticosteroid-sparing agent for chronic non-infectious uveitis in
participants receiving oral corticosteroid therapy alone or combined with an
immunosuppressive agent in a proof-of-concept clinical trial.
Study Population: Patients with non-infectious uveitis requiring at least 20 mg but no more
than 40 mg of oral prednisone, or equipotent dose of alternative corticosteroid medication to
maintain a quiescent eye, will be eligible.
Design: In this single center, Phase I/II, double-masked, randomized, placebo-controlled,
parallel group treatment study, the safety and efficacy of the peptide B27PD will be
investigated in 60 participants with non-infectious uveitis. Initially, 60 participants were
to be enrolled; however, due to lack of efficacy, only 31 participants were enrolled.
Eligible participants will be randomized to one of three treatment groups: 1 mg B27PD, 4 mg
B27PD or placebo, to be taken three times per week for 24 weeks. All remaining participants
will be followed through a common termination date. The common termination date will be
established once the last enrolled participant reaches his/her Week 28 visit (four weeks
following his/her last investigational treatment).The time to recurrence of uveitis in either
eye occurring in the 52 weeks following the initial dosing will be evaluated in each
treatment group. Recurrence will be defined as an increase in anterior chamber cells and/or
vitreous haze of at least 2 steps [using the Standardization of Uveitis Nomenclature (SUN)
grading system]. Ophthalmic examinations to assess uveitis will include visual acuity,
intraocular pressure (IOP), slit lamp biomicroscopy, ophthalmoscopy, optical coherence
tomography (OCT) and fluorescein angiography.
Outcome Measures: The primary outcome variable is the time to recurrence of uveitis activity
in participants of each treatment group, during or after tapering of oral prednisone to a
dose of 7.5 mg/day, or equipotent dose of alternative corticosteroid medication. Secondary
efficacy outcome variables include the proportion of participants determined to be a
Treatment Failure, defined as recurrence (or flare) of uveitis (at least a 2-step increase
using the SUN grading system) or a drop in visual acuity of ≥ 15 Early Treatment Diabetic
Retinopathy Study (ETDRS) letters at 24 and 52 weeks. Other secondary efficacy outcomes
include the reduction in exposure to corticosteroid as measured by the area under the
dose-time curve, and changes in best-corrected visual acuity (BCVA), fluorescein angiography,
fundus autofluorescence and high-speed indocyanine green angiography (HS-ICG). Ocular safety
measurements include intraocular pressure (IOP) and optical coherence tomography (OCT) for
confirmation of suspected macular edema. Systemic safety variables include adverse events,
clinical blood chemistry and hematology, urinalysis, vital signs, weight and medical
evaluation at baseline and at the end of the study.
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