Phase 1 Uveitis Trial, Completed NCT00280826 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 medication called efalizumab and involved 6 participants in total. All 6 completed the study — none dropped out. The trial was measuring two main things: first, whether participants experienced any notable side effects, health problems, or infections while taking the medication; and second, whether there were any changes in a specific eye condition called cystoid macular oedema (a type of swelling in the central part of the eye) and in participants' vision over 16 weeks. The reported data shows that all 6 participants had systemic toxicities, adverse events, or infections recorded during the study — though the data does not break down what those events were or how serious they were. For the eye swelling measurements (taken using a scanning technology called optical coherence tomography, or OCT, which produces detailed images of the eye), the reported average swelling was 128 microns in the worse-seeing eye and 57 microns in the better-seeing eye. These figures represent the measurements at the time reported, but the data does not include a starting (baseline) figure for comparison, so the direction of change in swelling is not reported here. The reported data shows that vision — measured by how many letters participants could read on a standardised eye chart — changed by an average of 6.7 letters in the worse-seeing eye and 1.7 letters in the better-seeing eye over the 16-week period. Whether these changes represent an improvement or a worsening is not explicitly stated in the submitted data. Given that only 6 people took part, this was a very small study, and the numbers reflect only this particular group of participants. 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 1 Uveitis Trial, Completed

NCT00280826
Completed Phase 1

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 18 years of age or older
  • You have been diagnosed with a serious eye inflammation condition (uveitis, affecting the middle or back of the eye) for at least three months, which is causing ongoing fluid build-up in the central part of your retina (macular edema) in one or both eyes
  • Your eye condition currently requires at least 20mg per day of prednisone (a steroid), or a combination of two or more anti-inflammatory medications to keep it under control
  • You cannot tolerate the medications currently used for your eye condition, or you want to stop taking them because of unwanted side effects (actual or potential)
  • You have at least some useful vision in one eye (able to read the 20/200 line on an eye chart or better)
  • Your kidney and liver are functioning normally or with only mild problems (confirm with trial site)
  • You are not currently pregnant or breastfeeding
  • If you are sexually active and could potentially father or become pregnant, you agree to use acceptable birth control throughout the study and for six weeks after the last dose of the study medication
  • You are able to understand and sign a consent form agreeing to participate

Who may not be able to join:

  • You have previously been treated with certain specific antibody-based therapies targeting the immune system (called ICAM or LFA-1 directed monoclonal antibodies), or any other experimental treatment that could affect how this study's results are measured (confirm with trial site)
  • You currently have a significant active infection
  • You have been diagnosed with cancer (other than certain common skin cancers) within the past five years

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 1: approximately ~10% 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 1
Sponsor
National Eye Institute (NEI)
Registry
ClinicalTrials.gov
Start date
1 January 2006
Est. completion
1 February 2009

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of Participants With Systemic Toxicities, Adverse Events, or Infections

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