Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001865
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
HAT in Eye Complications of Behcets Disease
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Study to Investigate the Safety and Efficacy of HAT to Treat the Ocular Complications Related to Behcets Disease
Status:
COMPLETED
Status Verified Date:
2004-06
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 will evaluate the safety and effectiveness of Zenapax in controlling recurrent eye inflammations associated with Behcets disease
Behcets disease is usually treated with corticosteroids to suppress inflammation Other medicines such as methotrexate cyclophosphamide or azathioprine may also be used These drugs all can have serious side effects including liver or kidney damage Zenapax is a monoclonal antibody that binds to certain proteins receptors on white blood cells preventing them from interacting with a chemical called interleukin-2 Blocking this interaction prevents inflammation
This study will include 20 patients who had unacceptable side effects from other medicines used to treat their disease did not benefit from standard treatment and refused standard treatment because of possible side effects of the medicines
All patients in the study will continue to take their current medicines at the start of the study In addition one group of patients will receive Zenapax and a second group will receive a placebo The drug or placebo will be infused into the vein at the start of the study and every two weeks for the next six weeks and then every four weeks for the rest of the study period 24 months Each infusion lasts about 15 minutes Patients will have eye examinations at the time of every treatment and medicines will be added if needed to control eye disease Drugs will be tapered after six months in patients whose eye disease is quiet and readjusted as necessary Neither the doctors nor the patients will know who is receiving placebo and who is receiving Zenapax until the study ends
Patients will be given a physical examination medical history eye examination fluorescein angiography special photographs of the retina to evaluate the blood vessels in the eye and blood tests
Zenapax was previously studied in 10 patients with uveitis with positive results The patients were able to reduce the other medicines they were taking with minimal side effects
Behcets disease is usually treated with corticosteroids to suppress inflammation Other medicines such as methotrexate cyclophosphamide or azathioprine may also be used These drugs all can have serious side effects including liver or kidney damage Zenapax is a monoclonal antibody that binds to certain proteins receptors on white blood cells preventing them from interacting with a chemical called interleukin-2 Blocking this interaction prevents inflammation
This study will include 20 patients who had unacceptable side effects from other medicines used to treat their disease did not benefit from standard treatment and refused standard treatment because of possible side effects of the medicines
All patients in the study will continue to take their current medicines at the start of the study In addition one group of patients will receive Zenapax and a second group will receive a placebo The drug or placebo will be infused into the vein at the start of the study and every two weeks for the next six weeks and then every four weeks for the rest of the study period 24 months Each infusion lasts about 15 minutes Patients will have eye examinations at the time of every treatment and medicines will be added if needed to control eye disease Drugs will be tapered after six months in patients whose eye disease is quiet and readjusted as necessary Neither the doctors nor the patients will know who is receiving placebo and who is receiving Zenapax until the study ends
Patients will be given a physical examination medical history eye examination fluorescein angiography special photographs of the retina to evaluate the blood vessels in the eye and blood tests
Zenapax was previously studied in 10 patients with uveitis with positive results The patients were able to reduce the other medicines they were taking with minimal side effects
Detailed Description:
The development of an ideal therapy to immunosuppress patients with Behcets disease a cause of endogenous uveitis and a major cause of acquired blindness in adults is an important research goal Corticosteroids remain the mainstay of therapy for intraocular inflammation however many patients are intolerant or resistant to corticosteroid therapy Although the etiology of Behcets disease is unknown evidence suggests that an interleukin-2 receptor bearing auto-aggressive cells may play an important role in this disorder Zenapax a humanized anti-TAC T-cell activated antigen monoclonal antibody HAT has been utilized in Protocol 96-EI-0096 a pilot Phase III study to evaluate Zenapax administration in the treatment of patients with endogenous sight-threatening uveitis Long-term results demonstrate a positive therapeutic trend in this trial We propose a randomized masked pilot trial of Zenapax versus placebo Twenty patients who are 18 years of age or older with Behcets disease will be randomly assigned to receive either Zenapax or placebo in addition to their standard immunosuppressive therapy After six months of quiescent disease patients will be eligible to taper their standard immunosuppressive therapy The primary purpose of the study is to investigate the safety and efficacy of Zenapax in controlling the recurrent explosive nature of ocular manifestations in patients with Behcets disease Because this study is a Phase III study examining both efficacy and safety primary outcomes for each are defined The primary safety endpoint is one of the following a development of a life threatening complication namely an exacerbation of systemic or neurological disease or b the development of a severe opportunistic infection The primary efficacy outcomes of this study are based on the number of ocular attacks experienced and the amount of immunosuppressive medications over the 2 year study period including the ability to taper the standard immunosuppressive therapy Secondary efficacy outcomes include the level of inflammation as measured by vitreous haze and anterior chamber cells and flare the presence or absence of cystoid macular edema the change from baseline in visual acuity and quality of life issues as measured through questionnaires
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 |
|---|---|---|---|
| 99-EI-0135 | None | None | None |