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

NCT02911116 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 16016916-EI-0169
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uveitis

Keywords

Panuveitis; Intermediate Uveitis; Uveitis

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing a Treatment Response by Week 16

  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.

  Baseline to Week 16

Secondary Outcomes (18)

• Mean Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline

  Baseline to Week 4, Week 8, Week 12, Week 16, Week 28

• Mean Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline

  Baseline to Week 4, Week 8, Week 12, Week 16, Week 28

• Median Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline

  Baseline to Week 4, Week 8, Week 12, Week 16, Week 28

• Median Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline

  Baseline to Week 4, Week 8, Week 12, Week 16, Week 28

• Number of Participants Who Experience a Recurrence of Uveitis at All Follow-up Visits

  Week 4, Week 8, Week 12, Week 16

Other Outcomes (3)

• Number of Participants Experiencing a Clinically Significant Increase in Elevated Intraocular Pressure (IOP) at Any Follow-up Visit

  Week 4, Week 8, Week 12, Week 16, Week 28

• Proportion of Participants With ≥15 Letter Loss at Any Follow-up Visit.

  Week 4, Week 8, Week 12, Week 16, Week 28

• Number and Severity of Systemic and Ocular Toxicities and Adverse Events

  Baseline to Week 28

Study Arms (2)

Cohort 1 (Subcutaneous Only)

EXPERIMENTAL

Subcutaneous injections of Ustekinumab at baseline.

Drug: Ustekinumab

Cohort 2 (IV and Subcutaneous)

EXPERIMENTAL

Initial IV infusion of ustekinumab at baseline followed by one subcutaneous injection at Week 8. In participants who demonstrate an allergic reaction to the baseline IV infusion, the second dose at Week 8 can also be administered as an IV infusion instead of a subcutaneous injection.

Drug: Ustekinumab

Interventions

Ustekinumab DRUG

Subcutaneous Injection

Cohort 1 (Subcutaneous Only); Cohort 2 (IV and Subcutaneous)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has the ability to understand and sign the informed consent document.
• Participant is 18 years of age or older.
• Participant has negative purified protein derivative (PPD) or quantiferon testing done within three months prior to enrollment or had latent tuberculosis (TB) but has completed prophylactic anti-TB treatment.
• Participant has active intermediate uveitis, posterior uveitis or panuveitis in at least one eye requiring systemic therapy. Active disease is defined as:
• +1 or more vitreous haze (according to Standardization of Uveitis Nomenclature (SUN) criteria) AND/OR
• Active chorioretinitis or leakage on Fluorescein angiography (FA)(that is in more than one quadrant) that requires treatment.
• Participant has visual acuity in at least one eye of 20/400 or better.
• Participant is willing and able to comply with the study procedures.
• Female participants of childbearing potential must not be pregnant or breast-feeding, have a negative pregnancy test at screening and must be willing to undergo pregnancy testing throughout the study.
• Both female participants of childbearing potential and male participants able to father a child must have (or have a partner who has) had a hysterectomy or vasectomy, be completely abstinent from intercourse or must agree to practice two effective methods of contraception throughout the course of the study and for six weeks after the last investigational product injection. Acceptable methods of contraception for this study include:
• hormonal contraception (i.e., birth control pills, injected hormones, dermal patch or vaginal ring),
• intrauterine device,
• barrier methods (diaphragm, condom) with spermicide, or
• surgical sterilization (tubal ligation).

You may not qualify if:

• Participant has a significant active infection (an infection requiring treatment as determined by the medical team), including active tuberculosis or human immunodeficiency virus (HIV).
• Participant received a live vaccination within the past six weeks.
• Participant is expected to receive a live vaccination at any time during the study.
• Participant received the Bacillus Calmette-Guerin (BCG) vaccine within the past year.
• Participant is expected to receive the BCG vaccine at any time during the study or up to one year after discontinuing ustekinumab.
• Participant has a history of cancer (other than a non-melanoma skin cancer) diagnosed within the past five years.
• Participant has received intraocular (or periocular) steroid or anti-vascular endothelial growth factor (VEGF) injections within the last six weeks.
• Participant received rituximab within the last six months or another biologic agent (e.g., infliximab, daclizumab, adalimumab) within the last two months.
• Participant has received alkylating agents (e.g., cyclophosphamide, chlorambucil) within the last nine months.
• Participant has a known hypersensitivity to ustekinumab or any of its components.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Uveitis; Panuveitis; Uveitis, Intermediate

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: H. Nida Sen, MD, MHSc, Principal Investigator, NEI
• Organization: National Institutes of Health

senh@nei.nih.gov

301-402-3254

Study Officials

• Hatice N Sen, M.D.

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: September 22, 2016
• Study Start: March 30, 2017
• Primary Completion: March 5, 2020
• Study Completion: May 28, 2020
• Last Updated: March 26, 2021
• Results First Posted: March 26, 2021

Record last verified: 2020-12

Locations

US (1)