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UveitisPhase 1/2NCT01647152

Ustekinumab for Active Sight-Threatening Uveitis

A Phase 1/2 study testing Ustekinumab in people with Uveitis, run by National Eye Institute (NEI).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Uveitis
What is being tested?
Ustekinumab
How many people
0 participants
Where
No sites listed yet
Study dates
3 Jul 2012to 30 Jun 2015
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 1 or more anterior chamber cells (according to SUN criteria); and/or
  • 0.5 or more vitreous haze (according to SUN criteria); and/or
Show all 15Show fewer
  • 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).

Who cannot join

  • 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.

About this study

Official title: A Pilot Study to Investigate Ustekinumab (StelaraTM) for the Treatment of Active Sight-Threatening Uveitis

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.
Read more

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.
Read the detailed 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 8.

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 2 and 4 and every 12 weeks thereafter. Participants will continue to receive injections of ustekinumab every 12 weeks until Week 52. Participants will return for a final safety visit 12 weeks later.

Outcome Measures: The primary outcome is the number of participants who experience treatment response (as defined in Appendix 1) by Week 8. 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 Early Treatment Diabetic Retinopathy Study (ETDRS) letters and the number of participants who experience a substantial rise in elevated intraocular pressure (IOP).

Conditions
Uveitis
Being tested
Ustekinumab
Keywords
Uveitis, Ustekinumab, IL 12/23, Stelara
Medical subject headings
Uveitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UstekinumabDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2012 (estimated)
  2. Study start3 Jul 2012
  3. Primary completion30 Jun 2015 (estimated)
  4. Study completion30 Jun 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01647152
Sponsor's protocol ID
120168
Other IDs
12-EI-0168
Status last verified
5 Sep 2014
First submitted
19 Jul 2012
Last updated
5 Dec 2019
Results posted
No

Publications

  • 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.

    PubMed 15019324

  • 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.

    PubMed 12434489

  • 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.

    PubMed 18391061

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ustekinumab in people with Uveitis, run by National Eye Institute (NEI).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01647152, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2019.

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