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 looked at two medicines — methotrexate and mycophenolate mofetil — used to control inflammation inside the eye (a condition sometimes called uveitis). The trial ran in two phases. In the first phase (0–6 months), 107 people were assigned to methotrexate and 109 to mycophenolate mofetil. Those whose inflammation was not adequately controlled at 6 months were then switched to the other medicine for a further 6 months. The trial measured whether participants reached a defined level of controlled eye inflammation while also being on low doses of steroid eye drops and steroid tablets. The reported data shows that at the 6-month mark, 64 out of 107 participants in the methotrexate group and 56 out of 109 in the mycophenolate mofetil group met the trial's definition of controlled inflammation. Among those who had met that target at 6 months and stayed on the same medicine, the reported data shows that 48 out of 64 in the methotrexate group and 40 out of 56 in the mycophenolate mofetil group still met that target at 12 months. For participants who had not met the target and were switched to the other medicine, the reported data shows that 20 out of 42 who switched to methotrexate and 7 out of 32 who switched to mycophenolate mofetil then met the inflammation-control target in their second six-month phase. 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 37294447) ↗
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
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 been diagnosed with a non-infectious form of uveitis (inflammation inside the eye) affecting one or both eyes, involving the middle, front, back, or entire eye.
- You had active eye inflammation at some point in the last 180 days, shown by specific levels of inflammation in the front or back of the eye, or active lesions on the retina or choroid (confirm with trial site).
- You still have some level of active eye inflammation at the time of joining the study.
- At least one of the following applies to you: your inflammation did not go away after 4 weeks of high-dose steroid treatment or a steroid injection; your inflammation came back when steroids were reduced; you still have active inflammation after a long-acting steroid injection given 4 weeks to 180 days ago; you have been on more than 10mg/day of prednisone for at least 90 days and still have inflammation; OR you have a specific known eye condition (such as Behcet's disease with eye involvement, birdshot retinochoroidopathy, sympathetic ophthalmia, or similar conditions) that requires treatment to reduce steroid use.
- You are willing to start taking prednisone (a steroid) at the dose specified by the trial team at the beginning of the study.
- You are willing to limit your alcohol intake during the study.
- You are willing to use an acceptable form of contraception (such as medication, devices, or barrier methods) or abstain from sexual activity during the study period.
Who may not be able to join:
- Your uveitis is caused by an infection.
- You have used immune-suppressing medications (other than steroids) in the past 12 months.
- You have previously had bad reactions to, or safety problems with, the drugs methotrexate or mycophenolate mofetil.
- These drugs (methotrexate or mycophenolate mofetil) have previously failed to control your eye or other inflammation.
- You have ever received a biologic therapy (a type of advanced immune-suppressing drug) at any time.
- Both of your eyes have cloudiness (such as cataracts or corneal scarring) or severe scarring inside the eye that prevents a proper examination of the back of the eye.
- Both of your eyes have had persistently very low eye pressure (below 5 mmHg for more than 3 months) (confirm with trial site).
- You have had a steroid injection in or around the eye in the past 4 weeks.
- You have had a specific long-term steroid implant (fluocinolone acetonide) placed in either eye within the last 3 years.
- You have had eye surgery in the last 30 days, or are planning eye surgery in the next 6 months.
- The vision in your better eye is extremely poor (only able to detect hand movement or worse, even with glasses).
- You are under 16 years of age.
- You are pregnant, breastfeeding, or planning to become pregnant during the study period (a pregnancy test is required for all females who have not gone through menopause).
- You have a history of cancer — although a past history of non-melanoma skin cancer that is no longer active may still be considered (confirm with trial site).
- You have another autoimmune disease that is expected to require its own treatment plan that would interfere with this study.
- Recent blood test results show abnormally low white blood cell count, platelet count, or hemoglobin levels (taken within the last 4 weeks) (confirm with trial site).
- Recent blood tests show that your liver enzymes or kidney function values are significantly outside the normal range (taken within the last 4 weeks) (confirm with trial site).
- You have signs of active tuberculosis, HIV, syphilis, hepatitis B, or hepatitis C — specific tests for these infections are required within 90 days before joining the study.
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.
Contact this trial
Principal Investigator: Nisha Acharya, MD, MS, University of California, San Francisco
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Participants Achieving Treatment Success at 6 Months (Phase I, 0-6 Months)
Can't join this trial?
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.