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NCT02911116 · ClinicalTrials.gov registry record · Phase 2
Ustekinumab (STELARA) for the Treatment of Active Sight-Threatening Uveitis (STAR Study)
A Phase 2 study of Uveitis, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT02911116: Completed Phase 2 study of Uveitis, sponsored by National Eye Institute (NEI).
NCT02911116 is a Phase 2 study of Uveitis that has completed, run by National Eye Institute (NEI). The registered enrollment target is 8 participants, below the 617-participant average among 19 other Uveitis trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02911116, a Phase 2 study of Uveitis, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Uveitis is an inflammation of the eye that can cause vision loss. It is treated with medications and sometimes surgery. However, in many people, treatment does not always prevent loss of vision. A new medication, ustekinumab, reduces inflammation in patients with other inflammatory diseases. Therefore, it might be helpful in treatment of uveitis. Objective: To see if ustekinumab is safe and can help people with uveitis. Eligibility: People ages 18 and older with uveitis Design: Participants will be screened with: Medical and eye disease history Physical exam Eye exam: The pupil is dilated with eye drops. A machine scans the back of the eye. Pictures are taken of the inside of the eye. Blood and urine tests Tuberculosis test Participants will have 6 clinic visits over 28 weeks. Visits lasts 2-3 hours and include: * Medical and eye disease history * Physical and eye exams * Blood and urine tests * Fluorescein angiography: A needle guides a thin plastic tube into an arm vein. A dye is injected into the tube. The dye travels through the veins up to the blood vessels in the eyes. A camera takes pictures of the dye as it flows through the blood vessels in the eyes. * Cohort 1 - Ustekinumab injections at Weeks 0, 4, and 8: The injection is under the skin of the upper arm, leg, or abdomen. Participants will have their uveitis monitored and receive standard uveitis care during the study. * Cohort 2 - Ustekinumab injections via intravenous (IV) injection at first visit, followed by a single 90 mg injection of ustekinumab under the skin of the upper arm, leg or abdomen. For the IV injection a needle will be used to guide a thin plastic tube (catheter) into one of the arm veins. The needle will be removed, leaving only the catheter in the vein.
Primary Outcome
The primary outcome is the number of participants in each cohort who experience a treatment response by Week 16. Treatment response is defined as experiencing all of the following for both/eligible eyes: no active inflammatory chorioretinal lesion and/or absent or decreased retinal vascular leakage; ≤ 0.5+ anterior chamber (AC) cells; ≤ 0.5+ vitreous haze.
Conditions Studied
Interventions
- DRUG Ustekinumab
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2017-03-30 |
| Est. Completion | 2020-05-28 |
| Phase | Phase 2 |
What the finished NCT02911116 record still lists
NCT02911116 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 617-participant average among 19 other Uveitis trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Uveitis appearing as the primary indexed condition, and to 1 intervention - of which Ustekinumab is the first listed.
NCT02911116 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02911116 about?
NCT02911116 is a clinical study titled "Ustekinumab (STELARA) for the Treatment of Active Sight-Threatening Uveitis (STAR Study)". Background: Uveitis is an inflammation of the eye that can cause vision loss. It is treated with medications and sometimes surgery. However, in many people, treatment does not always prevent loss of vision. A new medication, ustekinumab, reduces inflammation in patients with other inflammatory dise...
What is the current status of trial NCT02911116?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2017-03-30. Estimated completion is 2020-05-28.
What conditions does trial NCT02911116 study?
This clinical trial studies the following conditions: Uveitis.
What interventions are being tested in trial NCT02911116?
The interventions under investigation include: Ustekinumab (DRUG).
Who is sponsoring clinical trial NCT02911116?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02911116 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Uveitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02911116's enrollment target sits among peer trials
8 20th of 19 the lowest of 19 other Uveitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Uveitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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