UveitisPhase 1NCT00001526
ANTI-TAC THERAPY FOR UVEITIS
A Phase 1 study testing Daclizumab (Zenapax) in people with Uveitis, run by National Eye Institute (NEI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis
- What is being tested?
- Daclizumab (Zenapax)
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 1996to 6 Sep 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 orginal enrollment, requiring 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 20/63 or better (ETDRS, logMAR less than 0.54).
- Participant has normal renal or liver function or evidence of no worse than mild abnormalities as defined by the WHO/NEI criteria.
- Participant is not currently pregnant or lactating.
- Participant with reproductive potential and who is sexually active agrees to use acceptable birth control methods throughout the course of the study.
Who cannot join
- Participants under the age of 18 years.
- Participants who had received previous treatment with an IL-2 directed monoclonal antibody or any other investigational agent that would interfere with the ability to evaluate the safety, efficacy or pharmacokinetics of daclizumab.
- Participants with a history or diagnosis of Behcet's disease.
- 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.
- Participant is hypersensitive to fluorescein dye.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Trial of Treatment of Non-Infectious Intermediate and Posterior Uveitis With Humanized Anti-Tac Antibody Therapy
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 mg/kg followed by 1 mg/kg 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.
Read more
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 mg/kg.
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.
Read the 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 mg/kg followed by 1 mg/kg 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 mg/kg.
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.
- Conditions
- Uveitis
- Being tested
- Daclizumab (Zenapax)
- Keywords
- Uveitis, Interleukin 2 Receptor, Daclizumab, HAT, Zenapax, Interleukin 2
- Medical subject headings
- Uveitis, Diabetes Mellitus, Insulin-Dependent, 10
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daclizumab (Zenapax)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start4 Jun 1996
- Study completion6 Sep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001526
- Sponsor's protocol ID
- 960096
- Other IDs
- 96-EI-0096
- Status last verified
- 6 Sep 2007
- First submitted
- 3 Nov 1999
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Brown PS Jr, Parenteau GL, Dirbas FM, Garsia RJ, Goldman CK, Bukowski MA, Junghans RP, Queen C, Hakimi J, Benjamin WR, et al. Anti-Tac-H, a humanized antibody to the interleukin 2 receptor, prolongs primate cardiac allograft survival. Proc Natl Acad Sci U S A. 1991 Apr 1;88(7):2663-7. doi: 10.1073/pnas.88.7.2663.
PubMed 2011577
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Treatment of Non-Infectious Intermediate and Posterior Uveitis With Humanized Anti-Tac Antibody Therapy
- ClinicalTrials.gov ID
- NCT00001526
- Acronym / sponsor ID
- 960096
- Conditions
- Uveitis
- Keywords
- Uveitis, Interleukin 2 Receptor, Daclizumab, HAT, Zenapax, Interleukin 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 4 Jun 1996
- Study completion
- 6 Sep 2007
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 mg/kg followed by 1 mg/kg 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 mg/kg.
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 mg/kg followed by 1 mg/kg 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 mg/kg.
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 design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 orginal enrollment, requiring 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 20/63 or better (ETDRS, logMAR less than 0.54).
- Participant has normal renal or liver function or evidence of no worse than mild abnormalities as defined by the WHO/NEI criteria.
Key exclusion criteria (6 listed)
- Participants under the age of 18 years.
- Participants who had received previous treatment with an IL-2 directed monoclonal antibody or any other investigational agent that would interfere with the ability to evaluate the safety, efficacy or pharmacokinetics of daclizumab.
- Participants with a history or diagnosis of Behcet's disease.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daclizumab (Zenapax) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 2011577Brown PS Jr, Parenteau GL, Dirbas FM, Garsia RJ, Goldman CK, Bukowski MA, Junghans RP, Queen C, Hakimi J, Benjamin WR, et al. Anti-Tac-H, a humanized antibody to the interleukin 2 receptor, prolongs primate cardiac allograft survival. Proc Natl Acad Sci U S A. 1991 Apr 1;88(7):2663-7. doi: 10.1073/pnas.88.7.2663.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Daclizumab (Zenapax) in people with Uveitis, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001526, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.