Optiquel(Trademark) as Corticosteroid-sparing Therapy for Chronic Noninfectious Uveitis
- 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(Trademark) is a natural product. It is an experimental medication being tested for its effectiveness again 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 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.
- To evaluate the safety and effectiveness of B27PD (Optiquel(Trademark)) as a treatment for uveitis.
- 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.
- Participants will be screened with a physical examination, medical history, blood and urine tests, and an eye exam.
- This study will last 52 weeks, with at least 17 study visits.
- Participants will be divided into three groups, and will randomly be selected to receive 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 pill three times per week on Monday, Wednesday, and Friday, for a total of 26 weeks. The pill should be taken in the morning (at least 4 hours after eating and at least 30 minutes before eating). Participants may take the pill with water, but should not consume any other beverages or any kind of food until at least 30 minutes have passed to prevent stomach upset. The pills should be stored in the refrigerator.
- 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Peptide B27PD (Optiquel(Registered Trademark)) as Corticosteroid-sparing Therapy for Chronic Non-infectious Uveitis (BOOTS)|
- The objective of the proposed study is to evaluate the safety and efficacy of Optiquel(Trademark) as a corticosteroid-sparing agent for chronic non-infectious uveitis in participants receiving oral corticosteroid therapy alone or with an anti-me... [ Time Frame: Time from randomization to recurrence, loss to follow-up, or end of study ]
- Proportion of participants determine to be a Treatment Failure, defined as recurrent (or flare) of uveitis, defined as at least a 2-step increase in anterior chamber cells and/or vitreous haze (using SUN grading system) or a drop in visual acuit...
- Reduction in exposure to corticosteroid as measured by the area under the dose-time curve.
- Changes in best-corrected visual acuity (BCVA).
- Changes in fundus autofluorescence.
- Changes in HS-ICG.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Drug: Peptide B27PD
Objective: The objective of this study is to evaluate the safety and efficacy of the peptide B27PD (Optiquel(Trademark)) 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: Eligible 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. 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 and then will be followed for 28 weeks. 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 SUN grading system). Ophthalmic examinations to assess the 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 greater than or equal to 15 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.
|Contact: Dominic Obiyor, R.N.||(301) firstname.lastname@example.org|
|Contact: Robert B Nussenblatt, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Robert B Nussenblatt, M.D.||National Eye Institute (NEI)|