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NCT00001526 · ClinicalTrials.gov registry record · Phase 1
Anti-tac Therapy FOR Uveitis
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT00001526: Completed Phase 1 study, sponsored by National Eye Institute (NEI).
NCT00001526 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001526, a Phase 1 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study 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 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
Interventions
- DRUG Daclizumab (Zenapax)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 1996-06-04 |
| Est. Completion | 2007-09-06 |
| Phase | Phase 1 |
What the finished NCT00001526 record still lists
NCT00001526 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which Daclizumab (Zenapax) is the first listed.
NCT00001526 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001526 about?
NCT00001526 is a clinical study titled "Anti-tac Therapy FOR Uveitis". 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 st...
What is the current status of trial NCT00001526?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 1996-06-04. Estimated completion is 2007-09-06.
What interventions are being tested in trial NCT00001526?
The interventions under investigation include: Daclizumab (Zenapax) (DRUG).
Who is sponsoring clinical trial NCT00001526?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00001526's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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