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NCT01195948 · ClinicalTrials.gov registry record · Phase 1
Optiquel® as Corticosteroid-sparing Therapy for Chronic Noninfectious Uveitis
A Phase 1 study of Uveitis, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT01195948 is a Phase 1 study of Uveitis that has completed, run by National Eye Institute (NEI). The registered enrollment target is 31 participants, below the 616-participant average among 19 other Uveitis trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01195948, a Phase 1 study of Uveitis, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study 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 capsu
Conditions Studied
Interventions
- DRUG Placebo
- DRUG B27PD
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2010-08 |
| Est. Completion | 2014-02 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01195948
The ClinicalTrials.gov registry entry for NCT01195948 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 616-participant average among 19 other Uveitis trials with a reported enrollment target (95% lower). The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Uveitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01195948 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01195948 about?
NCT01195948 is a clinical study titled "Optiquel® as Corticosteroid-sparing Therapy for Chronic Noninfectious Uveitis". 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. Resea...
What is the current status of trial NCT01195948?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2010-08. Estimated completion is 2014-02.
What conditions does trial NCT01195948 study?
This clinical trial studies the following conditions: Uveitis.
What interventions are being tested in trial NCT01195948?
The interventions under investigation include: Placebo (DRUG), B27PD (DRUG).
Who is sponsoring clinical trial NCT01195948?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01195948 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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