Phase 2 Uveitis Trial, Completed NCT01376362 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 5 participants, all of whom completed the study — none dropped out. All participants received a treatment called Interferon Gamma-1b. The trial was measuring changes in the thickness of the central part of the retina (the macula, a small area at the back of the eye responsible for sharp, central vision) in two eyes: the "study eye" (the eye being treated) and the "fellow eye" (the other eye). These measurements were taken using a scanning technique called OCT, which creates detailed images of the eye's layers without any cuts or needles. Measurements were taken at the start of the trial (baseline) and again at one week and two weeks. The reported data shows that in the study eye, the central macular thickness decreased by an average of 38.60 micrometres (very small units of measurement) by week one, and by 47.40 micrometres by week two, compared to the starting measurement. In the fellow eye — which was not the focus of treatment — the reported data shows the thickness actually increased by an average of 12.00 micrometres at week one and 30.20 micrometres at week two. For the overall volume of the macula (measured in cubic millimetres), the study eye showed a very small average decrease of 0.02 cubic millimetres at week one, while the fellow eye showed a small average increase of 0.14 cubic millimetres at week one. Changes in macular volume at week two were not reported in the data. It is worth noting that with only 5 participants, this was a very small study, and no comparison group (such as a placebo group) was included in the reported data. 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

NCT01376362
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 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 the retina (a condition called CME) caused by eye inflammation (uveitis) in at least one eye, confirmed by a special eye scan.
  • You must be willing to follow all study procedures and be able to attend all required appointments.
  • You must have a vision level of at least 20/400 (some usable vision) in the eye being studied.
  • If you are a woman who could become pregnant, you must not currently be pregnant or breastfeeding.
  • If you could become pregnant or father a child, you must agree to use two approved forms of birth control during the study and for six weeks after the last dose of the study treatment (acceptable methods include birth control pills, hormonal injections, skin patches, vaginal rings, an IUD, barrier methods with spermicide, or permanent surgical options).

Who may not be able to join:

  • You may not be eligible if you are unable to tolerate eye drops or follow the study's required procedures.
  • You may not be eligible if you currently have a significant active infection that your doctor believes would make it unsafe for you to participate.
  • You may not be eligible if you have been diagnosed with multiple sclerosis (MS), as the study treatment could potentially make MS worse.

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 June 2011
Est. completion
1 February 2012

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Excess Central Macular Thickening in the Study Eye, as Measured by Optical Coherence Tomography (OCT), at Week One Compared to 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