Phase 2 Uveitis Trial, Completed NCT00130637 Sponsor: National Eye Institute (NEI) Condition: Uveitis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called daclizumab in people with a type of eye inflammation linked to juvenile idiopathic arthritis (JIA) — a condition where the joints and sometimes the eyes become inflamed in children. Six participants were enrolled in the study overall. Three participants completed the trial, and three did not finish. The trial was measuring two things: whether daclizumab could reduce eye inflammation by a meaningful amount, and whether any serious unwanted medical events (known as serious adverse events) occurred while taking the medicine. The reported data shows that, out of the six participants, five were reported to have achieved a significant reduction in their eye inflammation — specifically, a drop of at least two steps on a scale used to measure inflammation in the front of the eye (where 0 means almost no inflammation and 4+ means very heavy inflammation). This reduction also had to occur while the participant was using eye drop steroids fewer than three times a day. Regarding safety, the reported data shows that one out of the six participants experienced a serious adverse event during the study, though the specific nature of that event was not detailed in the data provided here. It is worth noting that this was a very small trial with only six participants, so the numbers are based on a limited group of people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Uveitis Trial, Completed

NCT00130637
Completed Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 6 and 18 years old (inclusive)
  • You have been diagnosed with eye inflammation (uveitis) that is linked to a condition called juvenile idiopathic arthritis (JIA), and it requires anti-inflammatory treatment given 3 or more times a day
  • Your uveitis is still considered active even while on your current treatment
  • There is a measurable level of inflammation (at least grade 1+) in the front part of at least one eye
  • Your uveitis may or may not currently be treated at the time of joining the study
  • You have usable vision of at least 20/640 or better in at least one eye
  • Your kidney and liver function test results are normal or only mildly abnormal, within specific limits set by the study (confirm with trial site)
  • You agree not to have any planned, non-urgent eye surgery (such as cataract removal) during the first 6 months of the study
  • Your blood count shows enough of a type of white blood cell called neutrophils (above 750) (confirm with trial site)
  • You are not currently pregnant or breastfeeding
  • If you are sexually active and could become pregnant or father a child, you agree to use an acceptable form of birth control during the study and for 6 months after treatment ends
  • A parent or legal guardian is able to read, understand, and sign a consent form on your behalf, and you are willing to sign an assent form yourself
  • You have already been diagnosed with juvenile rheumatoid arthritis or JIA for some time (not newly diagnosed) and have already received treatment for your uveitis
  • You are able to have a specific eye examination called slit lamp biomicroscopy to assess eye inflammation
  • You are able to follow and meet all the requirements of the study
  • You are up to date on all recommended childhood vaccinations

Who may not be able to join:

  • You are under 6 years of age
  • You have previously been treated with a specific type of medication called an IL-2 directed monoclonal antibody, or any experimental drug that could affect how this study measures safety or effectiveness
  • You have a history of or have been diagnosed with a condition called Behçet's disease
  • You currently have a significant active infection
  • You have been diagnosed with cancer (other than a certain type of skin cancer) within the past 5 years
  • You have used an eye drop medication called latanoprost (Xalatan) within two weeks before joining the study, or are likely to need it
  • You cannot receive fluorescein dye (a dye used in certain eye tests) for medical reasons
  • There is cloudiness in your eye that prevents doctors from properly assessing your eye inflammation
  • You are female and are currently pregnant or breastfeeding
  • You are not willing to use contraception during the study and for 6 months after treatment ends, if you could become pregnant or father a child
  • You have serious active infections, or a history of serious infections that keep coming back
  • You show signs of a related condition affecting the spine or where tendons attach to bones (confirm with trial site)
  • Your joint or body-wide inflammation is severe enough that it immediately requires adding or increasing systemic anti-inflammatory medications

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Completed
Phase
Phase 2
Sponsor
National Eye Institute (NEI)
Registry
ClinicalTrials.gov
Start date
1 August 2005
Est. completion
1 May 2008

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of Participants With a Two-step Reduction in Inflammation; Number of Participants Reporting a Serious Adverse Event (SAE)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov