Ustekinumab for Active Sight-Threatening Uveitis

NCT01647152 | Withdrawn Phase 1

• 2 other identifiers: 12016812-EI-0168
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Uveitis; Ustekinumab; IL 12/23; Stelara

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the number of participants who experience at least a 2-step (or down to grade 0) reduction in inflammation as per the Standardization of Uveitis Nomenclature (SUN) criteria by Week 8.

Interventions

Ustekinumab DRUG

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 PPD or quantiferon testing done within three months prior to enrollment or had latent 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:
• or more anterior chamber cells (according to SUN criteria); and/or
• or more vitreous haze (according to SUN criteria); and/or
• Active chorioretinitis or greater than or equal to quadrants with leakage on FA.
• 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 anytime 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-VEGF injections within the last six weeks.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Related Publications (3)

• Gritz DC, Wong IG. Incidence and prevalence of uveitis in Northern California; the Northern California Epidemiology of Uveitis Study. Ophthalmology. 2004 Mar;111(3):491-500; discussion 500. doi: 10.1016/j.ophtha.2003.06.014.

  PMID: 15019324 BACKGROUND

• Djalilian AR, Nussenblatt RB. Immunosuppression in uveitis. Ophthalmol Clin North Am. 2002 Sep;15(3):395-404, viii. doi: 10.1016/s0896-1549(02)00036-6.

  PMID: 12434489 BACKGROUND

• Luger D, Silver PB, Tang J, Cua D, Chen Z, Iwakura Y, Bowman EP, Sgambellone NM, Chan CC, Caspi RR. Either a Th17 or a Th1 effector response can drive autoimmunity: conditions of disease induction affect dominant effector category. J Exp Med. 2008 Apr 14;205(4):799-810. doi: 10.1084/jem.20071258. Epub 2008 Apr 7.

  PMID: 18391061 BACKGROUND

MeSH Terms

Conditions

Uveitis

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

Study Officials

• Hatice N Sen, M.D.

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: July 20, 2012
• Study Start: July 3, 2012
• Primary Completion: June 30, 2015
• Study Completion: June 30, 2015
• Last Updated: December 5, 2019

Record last verified: 2014-09-05