Ustekinumab for Active Sight-Threatening Uveitis

• Status: Withdrawn
• Trial end date: 2015-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Eye Institute (NEI)
• Treatments: Ustekinumab

Criteria

• 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.