Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00280826
Status:
COMPLETED
Last Update Posted:
2011-02-02
First Post:
2006-01-21
Brief Title:
Efalizumab to Treat Uveitis
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Treatment of Non-Infectious Intermediate and Posterior Uveitis Associated Macular Edema With Humanized Anti-CD11a Antibody Therapy
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
Participants 18 and older with sight-threatening intermediate or posterior uveitis of at least 3 months duration causing persistent macular edema in one or both eyes were eligible for this study The uveitis required 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
Participants underwent the following tests and procedures
Medical history and physical examination
Weekly efalizumab treatment
Weekly eye examination including measurement of vision and pressure in the eyes dilation of the eyes and examination of the front and back parts of the eye
Weekly blood tests to measure the number and types of cells in the blood and to check for signs of inflammation and treatment side effects At some visits blood samples were collected to measure how much efalizumab remains in the blood and whether the body has developed an immune response to the medicine
Blood draw at enrollment and at 2 and 4 months for research tests to examine how participants immune response was operating
Fluorescein angiography at enrollment and 1 and 3 months after enrollment unless additional tests are needed for medical management This test checked for abnormalities of eye blood vessels A yellow dye was injected into an arm vein and travels to the blood vessels in the eyes Pictures of the retina the back portion of the eye were taken with a special camera that flashes a blue light into the eye The pictures show whether any dye has leaked from the vessels into the retina indicating possible abnormalities
Monthly pregnancy test for women who could become pregnant
Participants returned for treatment and clinic visits weekly for 16 weeks After 16 weeks participants whose macular edema had decreased and whose vision may have improved were offered to continue the injections
Participants 18 and older with sight-threatening intermediate or posterior uveitis of at least 3 months duration causing persistent macular edema in one or both eyes were eligible for this study The uveitis required 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
Participants underwent the following tests and procedures
Medical history and physical examination
Weekly efalizumab treatment
Weekly eye examination including measurement of vision and pressure in the eyes dilation of the eyes and examination of the front and back parts of the eye
Weekly blood tests to measure the number and types of cells in the blood and to check for signs of inflammation and treatment side effects At some visits blood samples were collected to measure how much efalizumab remains in the blood and whether the body has developed an immune response to the medicine
Blood draw at enrollment and at 2 and 4 months for research tests to examine how participants immune response was operating
Fluorescein angiography at enrollment and 1 and 3 months after enrollment unless additional tests are needed for medical management This test checked for abnormalities of eye blood vessels A yellow dye was injected into an arm vein and travels to the blood vessels in the eyes Pictures of the retina the back portion of the eye were taken with a special camera that flashes a blue light into the eye The pictures show whether any dye has leaked from the vessels into the retina indicating possible abnormalities
Monthly pregnancy test for women who could become pregnant
Participants returned for treatment and clinic visits weekly for 16 weeks After 16 weeks participants whose macular edema had decreased and whose vision may have improved were offered to continue the injections
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 effects Consequently an effective treatment with a safer side effect profile is highly desirable
Aims This protocol evaluated 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 was sustained using the SC formulation then maintenance therapy was continued as clinically indicated
Methods This was an open-label non-randomized clinical pilot study
Aims This protocol evaluated 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 was sustained using the SC formulation then maintenance therapy was continued as clinically indicated
Methods This was an open-label non-randomized clinical pilot study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-EI-0046 | OTHER | NIH Office of Protocol Services | None |