Ustekinumab for Active Sight-Threatening Uveitis
| Status: | Completed |
|---|---|
| Conditions: | Cervical Cancer, Ocular |
| Therapuetic Areas: | Oncology, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/8/2014 |
| Start Date: | July 2012 |
| End Date: | June 2015 |
| Contact: | Patti Sherry, R.N. |
| Email: | patti.sherry@nih.gov |
| Phone: | (301) 435-4529 |
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.
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.
- 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.
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).
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).
- INCLUSION CRITERIA:
1. Participant has the ability to understand and sign the informed consent
document.
2. Participant is 18 years of age or older.
3. 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.
4. 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
Active chorioretinitis or greater than or equal to quadrants with leakage on FA.
5. Participant has visual acuity in at least one eye of 20/400 or better.
6. Participant is willing and able to comply with the study procedures.
7. 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.
8. 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).
EXCLUSION CRITERIA:
1. Participant has a significant active infection (an infection requiring treatment as
determined by the medical team), including active tuberculosis or human
immunodeficiency virus (HIV).
2. Participant received a live vaccination within the past six weeks.
3. Participant is expected to receive a live vaccination at any time during the study.
4. Participant received the Bacillus Calmette-Guerin (BCG) vaccine within the past year.
5. Participant is expected to receive the BCG vaccine at anytime during the study or up
to one year after discontinuing ustekinumab.
6. Participant has a history of cancer (other than a non-melanoma skin cancer) diagnosed
within the past five years.
7. Participant has received intraocular (or periocular) steroid or anti-VEGF injections
within the last six weeks.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-4000
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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