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Clinical trialNCT02911116CompletedPhase 2Interventional

Ustekinumab (STELARA) for the Treatment of Active Sight-Threatening Uveitis (STAR Study)

SponsorNational Eye Institute (NEI)Enrollment8Uveitis
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

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Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • National Institutes of Health Clinical Center

    Bethesda, Maryland, United States

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Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

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Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Mar 2017
Primary completion
5 Mar 2020
Completion
28 May 2020
Last update posted
26 Mar 2021
Registered enrollment
8
Registry id
NCT02911116

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.