Phase 2 Uveitis Trial, Completed NCT02911116 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 eight people in total, split into two groups. Five participants received the treatment by injection under the skin only (Cohort 1), and three received it first through a drip into a vein and then by injection under the skin (Cohort 2). The trial was looking at a condition involving inflammation inside the eye (uveitis), and the main thing it set out to measure was how many people in each group showed a "treatment response" by Week 16 — meaning their eye inflammation had settled down according to specific criteria for things like fluid leakage and cell activity in the eye. One person in each group did not complete the study. The reported data shows that by Week 16, all participants who completed the study met the criteria for a treatment response — that was 4 out of 5 in Cohort 1 and 2 out of 3 in Cohort 2. For vision (measured as the number of letters read correctly on an eye chart), the reported changes from the starting point were small across both eyes and both groups at each check-up visit — generally shifting by only a few letters up or down at Weeks 4, 8, 12, 16, and 28. The reported data also shows that no participants in either group experienced a return of their uveitis symptoms at the Week 4, 8, or 12 check-ups; at Week 16, one participant in Cohort 1 was recorded as having a recurrence, while none in Cohort 2 did. It is worth noting that this was a very small trial with only eight participants, so the numbers on their own are limited in what they can tell us. 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

NCT02911116
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 18 years of age or older.
  • You are able to understand and sign a consent form agreeing to take part in the study.
  • You have had a recent tuberculosis (TB) skin or blood test that came back negative (done within the last 3 months), or you had a latent (inactive) TB infection but have already completed a full course of preventive TB treatment.
  • You have active inflammation inside at least one eye (specifically in the middle, back, or throughout the eye) that is serious enough to need treatment taken by mouth or injection into the body.
  • You have at least some usable vision in at least one eye (able to see at least the top letter on a standard eye chart, or 20/400 vision).
  • You are willing and able to follow all the study procedures and attend required visits.
  • If you are a woman who could become pregnant, you must not currently be pregnant or breastfeeding, and you must have a negative pregnancy test at the start of the study and agree to pregnancy testing throughout.
  • If you could become pregnant or father a child, you must agree to use two reliable forms of birth control throughout the study and for six weeks after your last dose (acceptable methods include hormonal contraception, an intrauterine device (IUD), barrier methods with spermicide, or surgical sterilization — or your partner has had a hysterectomy or vasectomy, or you are completely abstinent).

Who may not be able to join:

  • You currently have a significant active infection (one that requires treatment), including active tuberculosis or HIV.
  • You have received a live vaccine (such as MMR or chickenpox vaccine) in the past six weeks, or are expected to receive one at any point during the study.
  • You have received the BCG vaccine (a specific TB vaccine) within the past year, or are expected to receive it during the study or within one year after finishing the study treatment.
  • You have been diagnosed with cancer (other than a certain type of common skin cancer called non-melanoma skin cancer) within the past five years.
  • You have had steroid or anti-VEGF injections into or around your eye within the last six weeks.
  • You have received a medication called rituximab in the past six months, or certain other biologic medications (such as infliximab, daclizumab, or adalimumab) in the past two months.
  • You have received certain strong chemotherapy-type medications (called alkylating agents, such as cyclophosphamide or chlorambucil) within the last nine months.
  • You have a known allergy or sensitivity to the study drug (ustekinumab) or any of its ingredients.

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
30 March 2017
Est. completion
5 March 2020

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of Participants Experiencing a Treatment Response by Week 16

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