Status:
COMPLETED
ANTI-TAC THERAPY FOR UVEITIS
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Uveitis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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. Conse...
Detailed Description
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. Conse...
Eligibility Criteria
- INCLUSION CRITERIA
Participant is 18 years of age or older.
Participant has a diagnosis of sight-threatening, intermediate or posterior uveitis of at least three months duration prior to orginal enrollment, requiring treatment to control their intraocular inflammatory disease with at least 20 mg/day of prednisone (or equivalent) or any combination of two or more anti-inflammatory treatments for uveitis, including for example prednisone, cyclophosphamide, cyclosporine, azathioprine, mycophenolate mofetil, methotrexate, etc.
Participant exhibits intolerance to the indicated systemic medications required for their uveitis or, though their uveitis may be under control, wish to be taken off their present medications due to potential or actual unacceptable side effects.
Participant has visual acuity in at least one eye of 20/63 or better (ETDRS, logMAR less than 0.54).
Participant has normal renal or liver function or evidence of no worse than mild abnormalities as defined by the WHO/NEI criteria.
Participant is not currently pregnant or lactating.
Participant with reproductive potential and who is sexually active agrees to use acceptable birth control methods throughout the course of the study.
EXCLUSION CRITERIA
Participants under the age of 18 years.
Participants who had received previous treatment with an IL-2 directed monoclonal antibody or any other investigational agent that would interfere with the ability to evaluate the safety, efficacy or pharmacokinetics of daclizumab.
Participants with a history or diagnosis of Behcet's disease.
Participant has a significant active infection.
Participant has a history of cancer (other than a non-melanoma skin cancer) diagnosed within the past 5 years.
Participant is hypersensitive to fluorescein dye.
Key Trial Info
Start Date :
June 4 1996
Trial Type :
INTERVENTIONAL
End Date :
September 6 2007
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00001526
Start Date
June 4 1996
End Date
September 6 2007
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892