Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001526
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
1999-11-03
Brief Title:
ANTI-TAC THERAPY FOR UVEITIS
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Trial of Treatment of Non-Infectious Intermediate and Posterior Uveitis With Humanized Anti-Tac Antibody Therapy
Status:
COMPLETED
Status Verified Date:
2007-09-06
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:
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
This pilot study has permitted enrollment of up to 12 adults with non-infectious intermediate or posterior uveitis who require treatments to maintain visual function This extended protocol began with an evaluation of the safety and potential efficacy of intravenous IV daclizumab treatments for uveitis while reducing or eliminating standard medications commensurate with the standard of care As subcutaneous SC daclizumab treatments become available eligible participants will be offered continuing daclizumab treatments using the new SC formulation though they may elect to remain on the IV treatments If the therapeutic benefit is sustained using the SC formulation maintenance therapy will continue as clinically indicated Participants who repeatedly fail the SC therapy will be permitted to revert to the IV daclizumab regimen they previously used or may exit the study as treatment failures SC treatments begin with a short SC induction at 2 mgkg followed by 1 mgkg treatments on a 4-week schedule as the protocol originally specified Participants will be monitored routinely when each dose is received and additionally will participate in pharmacokinetic studies to monitor SC formulation bioavailability
Daclizumab is a humanized anti-Tac monoclonal antibody HAT Zenapax that interferes with inflammatory processes by its involvement with the interleukin 2 receptor IL-2R During the first 5 years of this study only an IV product was available The SC formulation is now available containing the same daclizumab drug product Preliminary studies indicate that the SC formulation is well tolerated by normal control subjects and other autoimmune disease patients at repeated doses up to 2 mgkg
The primary objectives are to examine the safety and potential efficacy of IV and later SC daclizumab while continuing to reduce other immunosuppressive medications commensurate with the standard of care Primary safety outcomes are the discontinuation of study therapy due to reduced vision or the occurrence of adverse events Secondary outcome measures include visual acuity and the grading of immunosuppressive medications anterior chamber and vitreous cells and vitreous haze
This pilot study has permitted enrollment of up to 12 adults with non-infectious intermediate or posterior uveitis who require treatments to maintain visual function This extended protocol began with an evaluation of the safety and potential efficacy of intravenous IV daclizumab treatments for uveitis while reducing or eliminating standard medications commensurate with the standard of care As subcutaneous SC daclizumab treatments become available eligible participants will be offered continuing daclizumab treatments using the new SC formulation though they may elect to remain on the IV treatments If the therapeutic benefit is sustained using the SC formulation maintenance therapy will continue as clinically indicated Participants who repeatedly fail the SC therapy will be permitted to revert to the IV daclizumab regimen they previously used or may exit the study as treatment failures SC treatments begin with a short SC induction at 2 mgkg followed by 1 mgkg treatments on a 4-week schedule as the protocol originally specified Participants will be monitored routinely when each dose is received and additionally will participate in pharmacokinetic studies to monitor SC formulation bioavailability
Daclizumab is a humanized anti-Tac monoclonal antibody HAT Zenapax that interferes with inflammatory processes by its involvement with the interleukin 2 receptor IL-2R During the first 5 years of this study only an IV product was available The SC formulation is now available containing the same daclizumab drug product Preliminary studies indicate that the SC formulation is well tolerated by normal control subjects and other autoimmune disease patients at repeated doses up to 2 mgkg
The primary objectives are to examine the safety and potential efficacy of IV and later SC daclizumab while continuing to reduce other immunosuppressive medications commensurate with the standard of care Primary safety outcomes are the discontinuation of study therapy due to reduced vision or the occurrence of adverse events Secondary outcome measures include visual acuity and the grading of immunosuppressive medications anterior chamber and vitreous cells and vitreous haze
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 Consequently an effective treatment with a safer side effect profile is highly desirable
This pilot study has permitted enrollment of up to 12 adults with non-infectious intermediate or posterior uveitis who require treatments to maintain visual function This extended protocol began with an evaluation of the safety and potential efficacy of intravenous IV daclizumab treatments for uveitis while reducing or eliminating standard medications commensurate with the standard of care As subcutaneous SC daclizumab treatments become available eligible participants will be offered continuing daclizumab treatments using the new SC formulation though they may elect to remain on the IV treatments If the therapeutic benefit is sustained using the SC formulation maintenance therapy will continue as clinically indicated Participants who repeatedly fail the SC therapy will be permitted to revert to the IV daclizumab regimen they previously used or may exit the study as treatment failures SC treatments begin with a short SC induction at 2 mgkg followed by 1 mgkg treatments on a 4-week schedule as the protocol originally specified Participants will be monitored routinely when each dose is received and additionally will participate in pharmacokinetic studies to monitor SC formulation bioavailability
Daclizumab is a humanized anti-Tac monoclonal antibody HAT Zenapax that interferes with inflammatory processes by its involvement with the interleukin 2 receptor IL-2R During the first 5 years of this study only an IV product was available The SC formulation is now available containing the same daclizumab drug product Preliminary studies indicate that the SC formulation is well tolerated by normal control subjects and other autoimmune disease patients at repeated doses up to 2 mgkg
The primary objectives are to examine the safety and potential efficacy of IV and later SC daclizumab while continuing to reduce other immunosuppressive medications commensurate with the standard of care Primary safety outcomes are the discontinuation of study therapy due to reduced vision or the occurrence of adverse events Secondary outcome measures include visual acuity and the grading of immunosuppressive medications anterior chamber and vitreous cells and vitreous haze
This pilot study has permitted enrollment of up to 12 adults with non-infectious intermediate or posterior uveitis who require treatments to maintain visual function This extended protocol began with an evaluation of the safety and potential efficacy of intravenous IV daclizumab treatments for uveitis while reducing or eliminating standard medications commensurate with the standard of care As subcutaneous SC daclizumab treatments become available eligible participants will be offered continuing daclizumab treatments using the new SC formulation though they may elect to remain on the IV treatments If the therapeutic benefit is sustained using the SC formulation maintenance therapy will continue as clinically indicated Participants who repeatedly fail the SC therapy will be permitted to revert to the IV daclizumab regimen they previously used or may exit the study as treatment failures SC treatments begin with a short SC induction at 2 mgkg followed by 1 mgkg treatments on a 4-week schedule as the protocol originally specified Participants will be monitored routinely when each dose is received and additionally will participate in pharmacokinetic studies to monitor SC formulation bioavailability
Daclizumab is a humanized anti-Tac monoclonal antibody HAT Zenapax that interferes with inflammatory processes by its involvement with the interleukin 2 receptor IL-2R During the first 5 years of this study only an IV product was available The SC formulation is now available containing the same daclizumab drug product Preliminary studies indicate that the SC formulation is well tolerated by normal control subjects and other autoimmune disease patients at repeated doses up to 2 mgkg
The primary objectives are to examine the safety and potential efficacy of IV and later SC daclizumab while continuing to reduce other immunosuppressive medications commensurate with the standard of care Primary safety outcomes are the discontinuation of study therapy due to reduced vision or the occurrence of adverse events Secondary outcome measures include visual acuity and the grading of immunosuppressive medications anterior chamber and vitreous cells and vitreous haze
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 |
|---|---|---|---|
| 96-EI-0096 | None | None | None |