Phase 2 Uveitis Trial, Terminated NCT01194674 Sponsor: National Institutes of Health Clinical Center (CC) 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 treatment called Microplasmin and involved only 2 participants, both of whom completed the study. The trial was originally designed to measure both any unwanted health events (called adverse events) that occurred, and changes in the eye — specifically the thickness of a part of the retina called the macula, and whether a particular layer at the back of the eye separated as intended. The study closed earlier than planned because not enough people enrolled. The reported data shows that across the 2 participants, a total of 4 adverse events (unexpected or unwanted health occurrences) were recorded. Of those, 1 was related to the eye and 3 were not eye-related. Importantly, the reported data shows that 0 severe adverse events were recorded. No numbers are available for the two secondary outcomes — changes in retinal thickness and the separation of the layer at the back of the eye — because the researchers stated there was insufficient data to report these results due to the early closure of the trial. It is worth noting that with only 2 participants completing this study, the reported figures represent an extremely small snapshot and cannot be used to draw broad conclusions. The reported data shows only what was observed in this very limited group under the specific conditions of this trial. 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

NCT01194674
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 willing and able to read, understand, and sign a consent form for the study.
  • You must have been diagnosed with swelling in the central part of your eye (macular edema) caused by eye inflammation (uveitis), requiring treatment in at least one eye, and the inflammation in that eye must currently be considered calm and not active by the doctor.
  • There must be no signs of a certain type of separation of the gel inside your eye (called posterior vitreous detachment) in the study eye, as confirmed by specific eye scans.
  • Your vision in the study eye must be at least 20/400 (even if this is quite poor, it meets the minimum requirement).
  • The central part of your retina must be thicker than normal (at least 270 microns) and show a change in its usual shape, as seen on an eye scan.
  • Any cloudiness in your eye's lens or other structures must not be severe enough to block the doctor's view of the back of your eye.
  • If you are a woman who could become pregnant, you must not currently be pregnant or breastfeeding, and must have a negative pregnancy test at the start of and throughout the study.
  • If you could become pregnant, or could father a child, you must agree to use two effective forms of birth control for six months after receiving the study treatment (acceptable methods include hormonal contraception, an IUD, barrier methods with spermicide, or surgical sterilisation — those who have had a hysterectomy or vasectomy, or whose partner has, are exempt from this requirement).
  • You must be willing to follow all study procedures and attend all required appointments.

Who may not be able to join:

  • You have uncontrolled glaucoma (high pressure in the study eye above 30 mmHg) that is not controlled even with medication.
  • You have a certain type of retinal thinning (lattice degeneration) in the study eye that the doctor considers high risk.
  • You have untreated holes or tears in your retina, or a hole in the central part of your retina (macular hole), in the study eye.
  • You have a significant active infection inside the study eye.
  • You have had eye surgery within the past 90 days, or are planning to have elective eye surgery in the study eye during the trial.
  • You have received an injection of bevacizumab or ranibizumab (certain eye medications) in the study eye within the past four weeks.
  • You have received an injection of triamcinolone (a steroid medication) in the study eye within the past six weeks.
  • You have any other health condition that, in the doctor's opinion, would make it unsafe or unsuitable for you to take part in the study.
  • You have a known severe allergic reaction to sodium fluoride, or have had certain serious allergic reactions to a dye called sodium fluorescein that cannot be safely managed with antihistamines or steroids beforehand.

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 Institutes of Health Clinical Center (CC)
Registry
ClinicalTrials.gov
Start date
1 January 2011
Est. completion
1 December 2011

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of Adverse Events; Number of Severe Adverse Events; Number of Ocular Adverse Events; Number of Non-ocular Adverse Events

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