Phase 3 Uveitis Trial, Completed NCT02251938 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 enrolled 60 people who received a single treatment called DE-109 440 μg (an eye injection). Of those 60 participants, 43 completed the study, while 17 did not finish. The trial was measuring several things related to eye health over 12 months, including how clearly participants could see (even with glasses or contact lenses), the fluid pressure inside the eye, the level of cloudiness or "haze" inside the eye, changes to two specific parts of the eye (the choroid and the macula), and how many participants needed additional treatments for their eye condition during the study. The reported data shows that, on average, participants' best-corrected vision (the sharpest vision possible with glasses or lenses) changed by 2.1 letters on a standard eye chart over 12 months, where a higher number means clearer vision. The fluid pressure inside the eye changed by an average of 0.3 mmHg (millimetres of mercury, a standard unit for eye pressure). The cloudiness score inside the eye changed by an average of -0.09 on a scale from 0 to 4, where a negative number indicates a small reduction in cloudiness. Regarding the need for extra treatment, the reported data shows that 9 out of the 60 participants required additional therapies for their eye condition during the study period. For the structural parts of the eye, the reported data shows that for the choroid (a layer at the back of the eye), 36 participants had findings reported as normal at both the start and end, while 4 shifted from normal to abnormal, 3 shifted from abnormal to normal, and none shifted from normal to normal in a different category — though some individual category figures were not fully detailed in the reported data. A similar breakdown was reported for the macula (the central part of the retina), with 20 participants recorded as normal throughout, 2 shifting from normal to abnormal, 6 shifting from abnormal to normal, and 15 remaining in an abnormal category throughout. 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, Completed

NCT02251938
Completed 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 previously took part in the SAKURA study
  • You saw a benefit from the treatment you received during the SAKURA study
  • You are able to give your written consent to participate and can attend all required study visits

Who may not be able to join:

  • Your eye inflammation (uveitis) is caused by an infection
  • You have an implanted medical device (confirm with trial site)
  • You have, or are suspected to have, lymphoma affecting the brain, spinal cord, or eyes
  • You have glaucoma that is not well controlled
  • You have a serious eye condition beyond the one being studied (confirm with trial site)
  • You have had injections into your eye within the last 60 days
  • You have had surgery or a medical procedure on your eye (confirm with trial site)
  • You currently have an infection in or around your eye
  • You have a history of herpes infection
  • You have or have had toxoplasmosis (a parasitic infection), or have scarring from it
  • You have a cancerous condition affecting your eye
  • You have previously had a vitrectomy (a type of eye surgery)
  • You have an allergy or bad reaction to the study medication
  • You have taken part in another clinical trial for uveitis involving a medical device within the last 30 days
  • You have a recent serious illness or infection affecting your whole body (confirm with trial site)
  • You are taking medication that suppresses your immune system, or your immune system is weakened
  • You have a cytomegalovirus (CMV) infection
  • You have a history of cancer that is currently in remission
  • You are pregnant, breastfeeding, or not using adequate contraception (applies to women who could become pregnant)
  • You use medical marijuana or illegal drugs
  • You have sarcoidosis (an inflammatory condition affecting the whole body)
  • You have received radiation therapy to your head or neck

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
Completed
Phase
Phase 3
Sponsor
Santen Inc.
Registry
ClinicalTrials.gov
Start date
29 September 2014
Est. completion
1 November 2017

Where this trial is recruiting

🇦🇹 Austria 🇫🇷 France 🇮🇳 India 🇮🇹 Italy Turkey (Türkiye) 🇺🇸 United States

Primary endpoints

Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 in the Study Eye; Mean Change From Baseline in Intraocular Pressure at Month 12 in the Study Eye; Number of Subjects With a Shift in Choroid Status at Month 12 in the Study Eye.; Changes From Baseline in Vitreous Haze (VH) Scores at Month 12; Number of Subjects Who Receive Rescue Therapy.; Number of Subjects With a Shift in Macula Status at Month 12 in the Study Eye.; Number of Subjects With a Shift in Optic Nerve Status at Month 12 in the Study Eye.; Number of Subjects With a Shift in Retina Status at Month 12 in the Stud...

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