Phase 2 Uveitis Trial, Terminated NCT01314417 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 enrolled just 2 participants, both of whom completed the study. The trial was looking at whether a medicine called methotrexate could reduce swelling at the back of the eye (specifically, swelling in a part of the eye called the macula). The main question the trial was designed to answer was how many participants showed a meaningful reduction in that swelling within 12 weeks of starting treatment. The reported data shows that both of the 2 participants met the trial's definition of "treatment success" within 12 weeks — meaning both showed at least a 20% reduction in the measured eye swelling, which was the threshold the researchers set as clinically meaningful. The reported data also shows changes in excess retinal (back-of-the-eye) thickening at several points across the study: at 4 weeks the average change from the starting measurement was 7.2%, at 8 weeks it was 9.9%, at 12 weeks it was 6.1%, at 16 weeks it was 13.6%, and at 20 weeks it was 4.9%. These figures represent the percentage change in swelling compared to where each participant started, though it is important to note these numbers come from only 2 people. It is worth noting that with only 2 participants, this trial was extremely small — far smaller than most clinical trials — and the results reported here are therefore very limited in what they can tell us broadly. 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, Terminated

NCT01314417
Terminated 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 must be 18 years of age or older.
  • You must be able to understand and sign a consent form agreeing to take part in the study.
  • You must be willing to follow the study procedures and attend all required visits.
  • You must have long-lasting swelling in the central part of the retina (the back of the eye) in at least one eye, caused by a type of non-infectious eye inflammation, that either has not improved with standard treatments in the past 3 months, or has come back while on standard treatments.
  • The swelling in your study eye must meet a certain thickness level (at least 270 microns, as measured by a scan of your eye).
  • You must have a minimum level of vision in your study eye (able to read at least some letters on a standard eye chart, roughly 20/400 or better).
  • If you are a woman who could become pregnant, you must not currently be pregnant or breastfeeding, and must have a negative pregnancy blood test at the start of the study, with further pregnancy tests throughout.
  • If you are a woman who could become pregnant, or a man who could father children, you must agree to use two reliable forms of birth control throughout the study and for six months after the last study injection (acceptable methods include hormonal contraception, an intrauterine device, barrier methods with spermicide, or surgical sterilisation), or have already had a hysterectomy or vasectomy, or be completely abstinent.

Who may not be able to join:

  • You are currently taking part in another research study that involves experimental treatment for retinal swelling.
  • Your eye inflammation appears to be caused by an infection.
  • You are expected to need eye surgery in your study eye at any point during the trial.
  • You have had eye surgery in your study eye within the last 90 days.
  • You have had certain anti-swelling injections (bevacizumab or ranibizumab) in your study eye within the last four weeks.
  • You have had a steroid injection called triamcinolone in your study eye within the last six weeks.
  • You have an overall health condition that the study doctor believes would make it unsafe for you to take part (confirm with trial site).
  • You have a significant cataract or cloudiness in your study eye that makes it difficult for the doctor to examine the back of your eye.
  • You have tested positive for HIV-1 or HIV-2.

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
Terminated
Phase
Phase 2
Sponsor
National Eye Institute (NEI)
Registry
ClinicalTrials.gov
Start date
1 February 2011
Est. completion
1 January 2013

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of Participants Who Meet the Definition of Treatment Success Within 12 Weeks From Baseline.

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