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| Sponsor: | National Eye Institute (NEI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00280826 |
Purpose
This study will examine the safety and effectiveness of the monoclonal antibody efalizumab (Raptiva) for treating sight-threatening uveitis (eye inflammation). Efalizumab controls the activity of white blood cells called lymphocytes that cause inflammation. The drug is currently approved in the United States to treat patients with moderate to severe psoriasis.
Patients 18 and older with sight-threatening intermediate or posterior uveitis of at least 3 months duration, causing persistent macular edema (swelling in the back part of the eye responsible for fine vision) in one or both eyes, may be eligible for this study. The uveitis must require treatment with at least 20 milligrams per day of prednisone, or the equivalent, or a combination of two or more anti-inflammatory treatments such as prednisone, methotrexate, cyclophosphamide, cyclosporine, etc. Patients must have visual acuity of 20/100 or better in at least one eye.
Participants undergo the following tests and procedures:
Patients return for treatment and clinic visits weekly for 16 weeks. After 16 weeks, patients whose macular edema has decreased and whose vision may have improved may be offered to continue the injections.
| Condition | Intervention | Phase |
|---|---|---|
|
Uveitis Intraocular Inflammatory Diseases |
Drug: Raptiva (efalizumab) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Treatment of Non-Infectious Intermediate and Posterior Uveitis Associated Macular Edema With Humanized Anti-CD11a Antibody Therapy |
| Estimated Enrollment: | 7 |
| Study Start Date: | January 2006 |
| Study Completion Date: | May 2006 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Treatment of cystoid macular edema due to uveitis
|
Drug: Raptiva (efalizumab)
Treatment of cystoid macular edema due to uveitis
|
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 effects. Consequently, an effective treatment with a safer side effect profile is highly desirable.
Aims: This protocol will evaluate the safety and potential efficacy of subcutaneous (SC) efalizumab (anti-CD11a) treatments for uveitis while reducing or eliminating standard medications commensurate with the standard of care. If the therapeutic benefit is sustained using the SC formulation, then maintenance therapy will continue as clinically indicated.
Methods: This is a Phase II non-randomized pilot study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Contacts and Locations
More Information
| Responsible Party: | National Institutes of Health ( Robert B. Nussenblatt, M.D./National Eye Institute ) |
| Study ID Numbers: | 060046, 06-EI-0046 |
| Study First Received: | January 21, 2006 |
| Last Updated: | August 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00280826 History of Changes |
| Health Authority: | United States: Federal Government |
|
OCT Retinal Disease Adhesion Molecule Ocular Inflammation Raptiva Macular Edema |
Uveitis Immunosuppression Uveitis Ocular Inflammation Retinal Disease |
|
Uveal Diseases Uveitis Eye Diseases |