Status:
COMPLETED
Efalizumab to Treat Uveitis
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Uveitis
Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study examined the safety and potential efficacy of the monoclonal antibody efalizumab (Raptiva) for treating sight-threatening uveitis (eye inflammation). Efalizumab controls the activity of whi...
Detailed Description
Background: Uveitis refers to intraocular inflammatory diseases that are an important cause of visual loss. Standard systemic immunosuppressive medications for uveitis can cause significant adverse ef...
Eligibility Criteria
Inclusion
- 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 original enrollment that is causing persistent cystoid macular edema in one or both eyes. Their disease requires 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 20/200 or better.
- Participant has normal renal or liver function or no worse than mild abnormalities as defined by the Common Toxicity Criteria.
- Participant is not currently pregnant or lactating.
- Both men and women with reproductive potential and who are sexually active agree to use acceptable birth control methods throughout the course of the study and for six weeks following the last administration of the study medication.
- Participant must have the ability to understand and sign an informed consent form.
Exclusion
- Participants who had received previous treatment with an intercellular adhesion molecule (ICAM) or lymphocyte function-associated antigen-1 (LFA-1) directed monoclonal antibody or any other investigational agent that would interfere with the ability to evaluate the safety, efficacy or pharmacokinetics of efalizumab.
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00280826
Start Date
January 1 2006
End Date
February 1 2009
Last Update
February 2 2011
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892