Phase 3 Uveitis Trial, Completed (NCT01232920)

Phase 3 Uveitis Trial, Completed NCT01232920 Sponsor: University of California, San Francisco Condition: Uveitis

Printed from Voxsanity (voxsanity.com.au) — NCT01232920 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

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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 80 people in total — 41 in the methotrexate group and 39 in the mycophenolate mofetil group. Both are medicines sometimes used to calm inflammation in the eye. The trial was measuring whether participants could get their eye inflammation under control while also reducing their steroid (prednisone) use to a low level, and keeping it there over at least two visits roughly a month apart. By the end of the study, 35 people in the methotrexate group and 32 in the mycophenolate mofetil group had completed the trial. The reported data shows that, for the main goal ("treatment success" as defined above), 24 out of 41 participants in the methotrexate group and 15 out of 39 in the mycophenolate mofetil group met that target. For one secondary measure — how long it took for inflammation to come under control — the reported figures were an average of 139 days for the methotrexate group and 124 days for the mycophenolate mofetil group. The trial also tracked changes in best corrected vision (measured on a technical scale called LogMAR, where a lower number means better vision); the reported change from the start of the trial was −0.26 for methotrexate and −0.19 for mycophenolate mofetil. Finally, the trial looked at how many eyes had swelling at the back of the eye (macular oedema) resolve; the reported data shows figures of 22 and 17 eyes in the methotrexate group, and 13 and 7 eyes in the mycophenolate mofetil group, though the data as submitted does not clearly label what each pair of numbers refers to, so those figures should be interpreted with caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 28414043) ↗

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.

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 uveitis (eye inflammation) that is not caused by an infection, affecting the front, middle, back, or entire part of the eye.
Your uveitis has been active within the last 60 days, meaning signs of inflammation were detected during an eye exam.
You are currently taking prednisone (a steroid medication) at a dose of 15 mg per day or more.
You have either been unable to reduce your prednisone dose to 10 mg or less, or your condition clearly requires additional medications to reduce your reliance on steroids.

Who may not be able to join:

Your uveitis is caused by an infection.
You have signs of active tuberculosis (TB) — though people with latent/inactive TB may still be eligible (confirm with trial site).
You have tested positive for Hepatitis B or Hepatitis C.
You have tested positive for syphilis.
Your blood test results show abnormally low levels of white blood cells, platelets, or hemoglobin.
Your liver or kidney function tests show abnormal results above a certain level.
You are currently pregnant or breastfeeding — all females who have not gone through menopause will need a pregnancy test.
You have had consistently very low eye pressure (below a certain level) for more than 3 months.
You have used any immune-suppressing medication for uveitis in the past 6 months.
You have previously tried and had no success with methotrexate or mycophenolate mofetil (specific immune-suppressing drugs).
You have had a steroid injection near or inside your eye within the past 3 months.
You have had a specific type of steroid implant surgery (fluocinolone acetonide) in either eye within the last 3 years.
You have had eye surgery within the last 30 days, or have any eye surgery planned during the 6-month study period.
The vision in your better eye is extremely limited (only able to detect hand movement or worse).
You are under 16 years of age.

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.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I found the following past clinical trial relevant to my condition, and wanted to raise it with you. It is no longer recruiting, but I wanted to ask whether similar active trials exist, or whether its results are relevant to my care:

Trial: NCT01232920

Sponsor: University of California, San Francisco

Phase: Phase 3

Status: Completed

Condition: Uveitis

More information: https://clinicaltrials.gov/study/NCT01232920

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You have uveitis (eye inflammation) that is not caused by an infection, affecting the front, middle, back, or entire part of the eye.
Your uveitis has been active within the last 60 days, meaning signs of inflammation were detected during an eye exam.
You are currently taking prednisone (a steroid medication) at a dose of 15 mg per day or more.
You have either been unable to reduce your prednisone dose to 10 mg or less, or your condition clearly requires additional medications to reduce your reliance on steroids.

Who may not be able to join:

Your uveitis is caused by an infection.
You have signs of active tuberculosis (TB) — though people with latent/inactive TB may still be eligible (confirm with trial site).
You have tested positive for Hepatitis B or Hepatitis C.
You have tested positive for syphilis.
Your blood test results show abnormally low levels of white blood cells, platelets, or hemoglobin.
Your liver or kidney function tests show abnormal results above a certain level.
You are currently pregnant or breastfeeding — all females who have not gone through menopause will need a pregnancy test.
You have had consistently very low eye pressure (below a certain level) for more than 3 months.
You have used any immune-suppressing medication for uveitis in the past 6 months.
You have previously tried and had no success with methotrexate or mycophenolate mofetil (specific immune-suppressing drugs).
You have had a steroid injection near or inside your eye within the past 3 months.
You have had a specific type of steroid implant surgery (fluocinolone acetonide) in either eye within the last 3 years.
You have had eye surgery within the last 30 days, or have any eye surgery planned during the 6-month study period.
The vision in your better eye is extremely limited (only able to detect hand movement or worse).
You are under 16 years of age.

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 28 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Completed

Phase

Phase 3

Sponsor

University of California, San Francisco

Registry

ClinicalTrials.gov

Start date

1 October 2010

Est. completion

1 June 2012

Where this trial is recruiting

🇮🇳 India

Primary endpoints

Number of Participants Achieving Treatment Success

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