Optiquel® as Corticosteroid-sparing Therapy for Chronic Noninfectious Uveitis

This is an interventional treatment trial for Uveitis focused on measuring Uveitis, Oral Tolerance Read More

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.