Phase 2 N=31 Randomized Triple-blind Treatment

Optiquel® as Corticosteroid-sparing Therapy for Chronic Noninfectious Uveitis

Uveitis

Bottom Line

View on ClinicalTrials.gov: NCT01195948 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2014

Primary outcome: Primary: The Primary Outcome is the Time to Recurrence of Uveitis 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. — 52; 52; 45 weeks

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: B27PD (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Eye Institute (NEI)
Primary completion: Nov 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY The Primary Outcome is the Time to Recurrence of Uveitis 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.	52; 52; 45	—
SECONDARY Proportion of Participants Determined to be a Treatment Failure, Defined as Recurrent (or Flare) of Uveitis or a Drop in Visual Acuity of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters	1; 3; 3	—
SECONDARY Proportion of Participants Determined to be a Treatment Failure, Defined as Recurrent (or Flare) of Uveitis or a Drop in Visual Acuity of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters	1; 3; 3	—
SECONDARY Mean Change in Best-Corrected Visual Acuity (BCVA) in Right Eye (OD) at Week 24 Compared to Baseline	1.50; 2.10; 2.80	—
SECONDARY Mean Change in Best-Corrected Visual Acuity (BCVA) in Left Eye (OS) at Week 24 Compared to Baseline	2.80; 2.00; 0.50	—
SECONDARY Number of Participants Presenting No Change in Retinal Vessel Leakage Observed by Fluorescein Angiography (FA) at Week 24 Compared to Baseline	9; 9; 7	—
SECONDARY Number of Participants Presenting No Change in Autofluorescence Patterns as Observed on Fundus Autofluorescence (FAF) at Week 24 Compared to Baseline	10; 10; 9	—
SECONDARY Reduction in Exposure to Corticosteroid as Measured by the Area Under the Dose-time Curve.	—	—
SECONDARY Changes in High-speed Indocyanine Green Angiography (HS-ICG)	0; 1; 0; 0; 2; 0	—

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.

Eligibility Criteria

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 wh

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Data sourced from ClinicalTrials.gov (NCT01195948). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.