A Phase 2 interventional study of Daclizumab in Non-infectious Intermediate and Posterior Uveitis, sponsored by National Eye Institute (NEI). Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-07-02.
Sponsored by National Eye Institute (NEI) · Phase 2, Interventional, and Treatment
This study will determine whether treatment with a combination of the drugs daclizumab and denileukin diftitox can eliminate the need for long-term daclizumab treatment in adult patients with uveitis. Denileukin diftitox kills white blood cells called lymphocytes that cause inflammation and may be the cause of uveitis.
Patients 18 years of age and older with uveitis in one or both eyes who are on daclizumab therapy and have not had a disease flareup in 6 months may be eligible for this study. Candidates are screened with a medical history, physical examination, eye examination (including vision test, examination of the front of the eye, and pupil dilation for examination of the retina at the back of the eye), blood tests and a questionnaire about their vision and daily activities.
After screening, participants undergo the following procedures:
We propose to investigate the possible efficacy of combination daclizumab and denileukin diftitox therapy to induce peripheral immune tolerance in participants presenting with non-infectious intermediate and posterior uveitis. This will be performed using a Phase I/II pilot study. Subjects whose disease is controlled on daclizumab therapy will have their daclizumab-dosing interval progressively increased by one-week increments. If and when they experience signs or symptoms of an ocular flare, they will be treated with denileukin diftitox, 24 hours after which they will receive their usual dose of daclizumab. Participants may receive up to 12 such cycles of daclizumab/denileukin diftitox therapy. When the daclizumab-dosing interval is 10 weeks long or less than 10% of their CD4 T cell CD25 is occupied by daclizumab, therapy will be discontinued. Following discontinuation of daclizumab patients will be followed for recurrence of ocular disease. Failure to reach this study point after 12 cycles or disease recurrence following discontinuation of therapy will constitute a study failure. The primary outcome will be the ability of the participant to be successfully tapered off daclizumab while their disease remains quiet (vitreous haze less than or equal to Trace) at week 104 while receiving no concomitant systemic immunosuppressive medications.
61 studies on the registry are indexed under Uveitis, Posterior; 4 are open to participants now.
This study's enrollment of 5 is below the median of 37 across 45 interventional studies indexed under Uveitis, Posterior.
Browse Uveitis, Posterior studies →National Eye Institute (NEI) is the lead sponsor of 272 studies on the registry; 17 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To be eligible to enroll in this study, a prospective participant must satisfy the following inclusion criteria.
EXCLUSION CRITERIA:
To be eligible to enroll in this study, a prospective participant must not satisfy any of the following exclusion criteria.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The record gives a start of May 2006 and a completion of Dec 2006. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Dec 2006. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Daclizumab
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