Phase 3 Uveitis Trial, Terminated NCT03711929 Sponsor: Santen Inc. 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 (NCT03711929) enrolled 145 participants across three groups during its first, double-masked phase: 57 received DE-109 injectable solution (the test treatment), 59 received a sham (dummy) procedure as a control, and 29 received DE-109 in a third "dummy arm." The trial was measuring eye inflammation — specifically a cloudiness inside the eye called "vitreous haze" — in people with a condition called uveitis (inflammation at the back of the eye). The main question the trial asked was: what proportion of treated eyes reached a vitreous haze score of zero (meaning no detectable inflammation) by the fifth month? The reported data shows that at month 5 — the primary measurement point — 15.7% of eyes in the main DE-109 group, 12.2% of eyes in the sham (control) group, and 28.7% of eyes in the dummy DE-109 arm reached a vitreous haze score of zero. At the earlier month 3 check, the reported figures were 14.7%, 5.5%, and 15.4% respectively. The trial also used a broader "composite score" (a scale from −1 to 3 that factored in improvement, worsening, and whether rescue treatments were needed). The reported data shows the average composite scores at month 3 were 0.4, 0.3, and 0.4 for the three groups, and at month 5 were 0.3, 0.3, and 0.6 respectively — all sitting near the lower end of that scale. These numbers are what was recorded and submitted; they do not on their own tell us whether any difference between the groups is meaningful, and no conclusions about why differences appeared between arms should be drawn from this summary alone. 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 3 Uveitis Trial, Terminated

NCT03711929
Terminated Phase 3

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 have active inflammation in the back part of your eye (called uveitis) that is not caused by an infection

Who may not be able to join:

  • You are a woman who is currently pregnant, breastfeeding, or planning to become pregnant
  • Your eye inflammation is caused by, or suspected to be caused by, an infection

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 3: approximately ~65% 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 3
Sponsor
Santen Inc.
Registry
ClinicalTrials.gov
Start date
19 November 2018
Est. completion
14 June 2022

Where this trial is recruiting

🇦🇷 Argentina 🇮🇳 India 🇮🇹 Italy 🇺🇸 United States

Primary endpoints

Vitreous Haze (VH) of Zero Response at Month 5

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