Optiquel® as Corticosteroid-sparing Therapy for Chronic Noninfectious Uveitis
| Status: | Completed |
|---|---|
| Conditions: | Cervical Cancer, Ocular |
| Therapuetic Areas: | Oncology, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/13/2018 |
| Start Date: | August 2010 |
| End Date: | February 2014 |
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.
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.
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.
INCLUSION CRITERIA:
- Participant must be 18 years of age or older.
- Participant must be able to understand the informed consent process and sign the
informed consent form.
- Participant has been diagnosed with non-infectious unilateral or bilateral uveitis for
at least three months. Participants who were diagnosed more than a year prior to
enrollment must have had a recurrence in ocular inflammation within the past year.
- Participant must be receiving a current treatment with prednisone between 20 to 40
mg/day (or an equipotent dose of an alternative corticosteroid). Participants who are
on a regimen of no more than one anti-metabolite inhibitor at the time of
randomization (e.g., azathioprine, methotrexate, mycophenolate) in addition to the
prednisone may be enrolled and are allowed to continue the anti-metabolite.
- The participant's uveitis must be controlled in eligible eyes, quiescent eyes
[anterior chamber cells and vitreous haze Standardization of Uveitis Nomenclature
(SUN) grade of 0].
- The participant's eligible eye(s) is able to be evaluated for activity of disease both
biomicroscopically and ophthalmoscopically.
- The participant's baseline intraocular pressure must be > 5 mmHg and ≤ to 30 mmHg in
both eyes. Concurrent use of intraocular pressure-lowering medication and/or prior
glaucoma surgery is acceptable.
- Participant has best-corrected distance visual acuity in the better seeing eye of
20/200 or better [≥ 34 Early Treatment Diabetic Retinopathy Study (ETDRS) letters].
- Female participants of childbearing potential must not be pregnant or lactating and
must be willing to undergo serum pregnancy tests throughout the study.
- Women of childbearing potential must agree to use reliable methods of contraception
while receiving the study medication and for 6 weeks following the last
administration. Acceptable methods of contraception include hormonal contraception
(i.e., birth control pills, injected hormones, dermal patch or vaginal ring),
intrauterine device, barrier methods with spermicide (diaphragm with spermicide,
condom with spermicide) or surgical sterilization (hysterectomy, tubal ligation or
partner with vasectomy).
EXCLUSION CRITERIA:
- Participant has a non-iatrogenic immunodeficiency state [e.g., Human Immunodeficiency
Virus (HIV) infection or congenital immunodeficiency].
- Participant had intraocular surgery or intraocular injection within three months prior
to randomization.
- Participant is expected to have an elective ocular surgery or intraocular injection
during the study period.
- Participant is using systemic corticosteroid therapy for a non-ocular disease or
non-ocular organ involvement.
- Participant has a history or diagnosis of Behcet's disease.
- Participant has a clinically suspected and/or confirmed central nervous system or
ocular lymphoma.
- Participant has an active systemic infectious disease or malignancy that requires
treatment.
- Participant has a known chronic disease or condition of the gastrointestinal system
that may interfere wih the absorption of the investigational product as determined by
the investigator (e.g., active hepatitis, chronic diarrhea, inflammatory bowel
disease, Crohn's disease, ulcerative colitis, celiac disease, diverticulosis or
diverticulitis).
- Participant has two or more food allergies.
- Participant has an implant containing anti-inflammatory, immunosuppressive or
antiviral drugs, unless a period 50% longer than the anticipated duration of effect of
the implant has elapsed.
- Participant received periocular corticosteroid injections within 4 months prior to
randomization or is expected to need periocular corticosteroid injections during the
study duration.
- Participant received treatment with infliximab, etanercept, adalimumab, interferon,
cyclosporine, tacrolimus, sirolimus, within two weeks prior to randomization.
- Participant received cytotoxic therapy (e.g., cyclophosphamide) within six months
prior to randomization.
- Participants for whom, in the physician's opinion, any of the protocol procedures may
pose a special risk not outweighed by the potential benefits of participating in the
study.
- Participant who is unlikely to comply with the study protocol or who is likely to be
moving or lost to follow-up.
- Participant who is currently enrolled or has been participating in any other
investigative therapeutic clinical trial during the three months prior to
randomization.
- Participant has a known need for a colonoscopy or surgery of the gastrointestinal
tract during the study.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Click here to add this to my saved trials
