Advertisement

Topics

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

2016-09-22 21:08:21 | BioPortfolio

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.

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.

Description

Objective: Uveitis refers to intraocular inflammatory diseases that are an important cause of visual loss. Standard systemic immunosuppressive medications for uveitis can cause significant adverse effects and many patients continue to experience disease flare-ups. Ustekinumab is a human IL-12 and -23 antagonist. The involvement of IL-12 and IL-23 in the pathophysiology of uveitis and other autoimmune diseases known to be associated with uveitis suggests that ustekinumab could be a potential treatment for uveitis. The study objective is to investigate the safety, tolerability and potential efficacy of subcutaneous injections of ustekinumab as a possible treatment for active intermediate uveitis, posterior uveitis or panuveitis.

Study Population: Five participants with active intermediate uveitis, posterior uveitis or panuveitis who meet the inclusion criteria will be initially enrolled. Up to seven participants may be enrolled, as up to two participants may be accrued to account for participants who withdraw from the study prior to Week 16.

Design: This is a prospective, non-randomized, uncontrolled, single-center pilot study to evaluate subcutaneous injections of ustekinumab as a possible treatment for active intermediate uveitis, posterior uveitis or panuveitis. Participants will receive a 90 mg subcutaneous injection of ustekinumab at baseline and a second and third injection at Week 4 and 8 for a total of 3 injections. Participants will continue in the study for a total of 28 weeks and will be able to receive standard of care after the first 16 weeks.

Outcome Measures: The primary outcome is the number of participants who experience treatment response by Week 16. Secondary outcomes include changes in visual acuity, the number of participants who experience a recurrence, the number of days to recurrence, presence or extent of macular edema, the amount of retino-vascular leakage, changes in retinal thickening, the length of time to quiescence and the ability to taper concomitant immunosuppressive medications. Safety outcomes include the number and severity of systemic and ocular toxicities and adverse events, the proportion of participants who experience vision loss of greater than or equal to 15 letters as measured by Electronic Visual Acuity (EVA) and the number of participants who experience a substantial rise in elevated intraocular pressure (IOP).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Uveitis

Intervention

Ustekinumab

Location

National Institutes of Health Clinical Center
Bethesda
Maryland
United States
20892

Status

Recruiting

Source

National Institutes of Health Clinical Center (CC)

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-09-22T21:08:21-0400

Clinical Trials [119 Associated Clinical Trials listed on BioPortfolio]

Efficacy and Safety of Ustekinumab, a Human Monoclonal Anti-IL-12/IL-23 Antibody, in Patients With Behçet Disease

The purpose of this study is to evaluate the proof of concept of efficacy of ustekinumab in subjects with Behçet disease, including patients with oral ulcers (STELABEC-1) and patients wi...

A Study of the Safety and Efficacy of Ustekinumab in Patients With Psoriatic Arthritis Who Have Prior Exposure to Anti TNF Agents

The purpose of this study is to evaluate the efficacy (improvement of signs and symptoms) and safety of ustekinumab in patients with psoriatic arthritis with a history of prior use of anti...

A Pharmacokinetic Study of Single-Dose Intravenous Ustekinumab Delivered in 2 Different Liquid in Vial Formulations

The purpose of this study is to evaluate the pharmacokinetic (PK) (blood levels) comparability of 2 different formulations of ustekinumab, 90 milligram per milliliter (mg/mL) liquid in via...

A Study of the Safety and Efficacy of Ustekinumab in Adolescent Patients With Psoriasis (CADMUS)

This is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients with moderate to severe psoriasis.

A Study of the Safety and Effectiveness of Ustekinumab in Patients With Psoriatic Arthritis

The purpose of this study is to evaluate the effectiveness (improvement of signs and symptoms) and safety of ustekinumab in participants with active psoriatic arthritis.

PubMed Articles [144 Associated PubMed Articles listed on BioPortfolio]

Patients with Refractory Crohn's Disease Successfully Treated with Ustekinumab.

Ustekinumab is a new biologic therapy targeting interleukin-12 and interleukin -23. It is currently approved for the treatment of psoriasis, but clinical trials have shown that it can induce and maint...

A Focus on the Epidemiology of Uveitis.

Uveitis is a common, sight-threatening inflammatory ocular disease and includes multiple heterogeneous clinical entities. The prevalence of various types of uveitis depends upon multiple factors, such...

Serial Frequencies and Clinical Features of Uveitis in Hokkaido, Japan.

Environmental and lifestyle changes influence the clinical features of uveitis. This study reviewed the epidemiologic trends of uveitis in the Japanese population.

Primed Mycobacterial Uveitis (PMU): Histologic and Cytokine Characterization of a Model of Uveitis in Rats.

The purpose of this study was to compare the histologic features and cytokine profiles of experimental autoimmune uveitis (EAU) and a primed mycobacterial uveitis (PMU) model in rats.

Hypopyon uveitis following panretinal photocoagulation.

We report the case of a 58-year-old man with proliferative diabetic retinopathy in both eyes, and a history of recurrent anterior uveitis in the right eye, who underwent panretinal laser photocoagulat...

Medical and Biotech [MESH] Definitions

Human histocompatibility (HLA) surface antigen encoded by the B locus on chromosome 6. It is strongly associated with acute anterior uveitis (UVEITIS, ANTERIOR); ANKYLOSING SPONDYLITIS; and REACTIVE ARTHRITIS.

Inflammation of the choroid as well as the retina and vitreous body. Some form of visual disturbance is usually present. The most important characteristics of posterior uveitis are vitreous opacities, choroiditis, and chorioretinitis.

Inflammation of the pars plana, ciliary body, and adjacent structures.

Abnormally low intraocular pressure often related to chronic inflammation (uveitis).

Inflammation of part or all of the uvea, the middle (vascular) tunic of the eye, and commonly involving the other tunics (sclera and cornea, and the retina). (Dorland, 27th ed)

More From BioPortfolio on "Ustekinumab (STELARA ) for the Treatment of Active Sight-Threatening Uveitis"

Quick Search
Advertisement
 

Relevant Topics

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Urology
Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...


Searches Linking to this Trial