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Ustekinumab for Active Sight-Threatening Uveitis

NCT01647152 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2019-12-05

No results posted yet for this study

Summary

Background:

\- Uveitis is an eye inflammation that can cause vision loss. It is treated with eye drops, drugs and sometimes surgery. In some people, treatment may not prevent vision loss. A type of white blood cells called T-cells often have a role in causing uveitis. In some cases of uveitis, T-cells attack the eye and cause inflammation. A drug called ustekinumab reduces inflammation from these T-cells. Researchers want to see if ustekinumab can be used to treat uveitis.

Objectives:

\- To see if ustekinumab can be used to treat uveitis.

Eligibility:

\- Individuals at least 18 years of age who have active uveitis that needs treatment.

Design:

* Participants will be screened with a physical exam, eye exam, and medical history. Blood and urine samples will be taken.
* Participants will have at least eight clinic visits during the 64-week study period. After the first visit, visits will occur at 2, 4, and 8 weeks, and then every 12 weeks.
* Participants will have a ustekinumab injection at the first study visit. They will have additional doses at the second and third visits, and then every 12 weeks until 1 year after the first dose (Week 52).
* Treatment will be monitored with frequent blood tests and eye exams. Other standard treatments for uveitis may be given as needed.
* There will be a final study visit 3 months after the last injection.

Conditions

  • Uveitis

Interventions

DRUG

Ustekinumab

Sponsors & Collaborators

  • National Eye Institute (NEI)

    lead NIH

Principal Investigators

  • Hatice N Sen, M.D. · National Eye Institute (NEI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-03
Primary Completion
2015-06-30
Completion
2015-06-30

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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 NCT01647152 on ClinicalTrials.gov