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Optiquel® as Corticosteroid-sparing Therapy for Chronic Noninfectious Uveitis

NCT01195948 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2018-09-11

Study results available
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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.

Conditions

  • Uveitis

Interventions

DRUG

B27PD

DRUG

Placebo

Capsule with no active ingredients to mimic B27PD

Sponsors & Collaborators

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • National Eye Institute (NEI)

    lead NIH

Principal Investigators

  • Robert B Nussenblatt, M.D. · National Eye Institute (NEI)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2013-11-30
Completion
2014-02-28

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01195948 on ClinicalTrials.gov