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 (NCT01694186) looked at a treatment for uveitis — a condition involving inflammation inside the eye. It enrolled 129 people in total: 42 received a sham (fake) injection as a comparison group, and 87 received an insert called the FAI (fluocinolone acetonide intravitreal) insert, which is a small device placed inside the eye to slowly release medicine. The main things being measured were whether the eye inflammation came back within 6 months of treatment, and what unwanted eye-related events occurred over 36 months. The reported data shows that when it came to the inflammation coming back within 6 months, 12 out of 42 people in the sham group had a recurrence, compared with 5 out of 87 people in the FAI insert group. Regarding eye-related unwanted events tracked over the study, the reported data shows that 39 people in the sham group and 77 people in the FAI insert group experienced at least one such event. Among more specific events recorded, 12 sham participants and 16 FAI participants experienced raised eye pressure; 21 sham and 60 FAI participants experienced new or worsening clouding of the lens (cataract); and 2 sham versus 11 FAI participants underwent a procedure related to cataract. No participants in either group were recorded in the final measurement category reported (which showed zero for both groups). The reported data shows a number of differences between the two groups across these measures, though it is important to note these are raw numbers only and do not on their own explain why differences occurred or what they mean for any individual. 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 32624244) ↗
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:
- People who are male or non-pregnant female, aged 18 or older at the time of signing consent
- People who have a history of recurring non-infectious uveitis (inflammation inside the eye) affecting the back of the eye, lasting more than 1 year, in one or both eyes
- People whose eye being studied has, in the 12 months before joining, either received treatment with steroid tablets or other systemic therapies for at least 3 months and/or at least 2 steroid injections in or around the eye for uveitis — OR has had at least 2 separate flare-ups of uveitis requiring steroid treatment by any of those routes
- People whose eye being studied has a low level of inflammation at the time of joining (fewer than 10 inflammatory cells visible in the front chamber of the eye, and only mild cloudiness in the gel at the back of the eye)
- People whose eye being studied has a vision level of at least 15 letters on a standard eye chart (ETDRS chart)
- People who are not planning any non-urgent eye surgery during the study period
- People who are able to understand and sign the consent form
- People who are willing and able to attend scheduled visits and follow the study procedures
Who may not be able to join:
- People with a known allergy to fluocinolone acetonide or any ingredient in the study implant
- People whose uveitis only affects the back of the eye and has never involved inflammation of the gel inside the eye or swelling at the centre of the retina
- People whose uveitis has only ever affected the front of the eye (iritis only), with no signs of inflammation elsewhere in the eye
- People whose uveitis is caused by an infection
- People who have bleeding inside the eye
- People whose eye inflammation is linked to a condition other than non-infectious uveitis (for example, lymphoma inside the eye)
- People with any eye cancer in either eye, including a type of eye tumour called choroidal melanoma
- People who have a scar from toxoplasmosis or from a previous viral retina infection in the eye being studied
- People with a history of viral retina infection
- People who currently have a viral, bacterial (mycobacterial), or fungal infection affecting the surface of the eye or eye structures
- People whose view of the retina and gel inside the eye is blocked by cloudiness in the eye
- People with a detached retina at the edge of the eye in the area where the implant would be placed
- People who have been diagnosed with glaucoma or high eye pressure in the eye being studied, unless a surgical procedure has already brought the eye pressure into the normal range (10–21 mmHg) and it has remained stable
- People whose eye pressure in the study eye is above 21 mmHg at screening, or who are currently using any eye drops to lower eye pressure in the study eye
- People with persistently very low eye pressure (below 6 mmHg)
- People who have had eye surgery on the study eye within 3 months before the study start date
- People who have had a laser capsule procedure (capsulotomy) on the study eye within 30 days before the study start date
- People who have received the Retisert implant in the study eye within the past 36 months
- People who have received the Ozurdex implant in the study eye within the past 6 months
- People who have received Triesence or Trivaris injections in the study eye within the past 3 months
- People who have had a steroid injection around the study eye within the past 3 months
- People who require high-dose ongoing steroid tablets (more than 15 mg of prednisone daily) or long-term immune-suppressing medications
- People who have had most types of cancer that are still being treated or have been in remission for less than 5 years (certain common skin cancers are excluded from this restriction)
- People who test positive for HIV or syphilis during screening
- People with uveitis caused by mycobacterial infection, or related scarring changes in either eye
- People who have had a systemic (whole-body) infection within 30 days before the study start date
- People with a serious ongoing medical or psychiatric condition that, in the investigator's judgement, could increase risk or affect study results
- People with any other eye or general health condition that, in the investigator's judgement, makes participation unsuitable
- People who have taken part in another drug or device trial within 30 days before the study start date
- People who are pregnant or breastfeeding, or people of childbearing potential who are unwilling or unable to use an accepted form of contraception from at least 14 days before the study start until the 12-month visit
- People who are unlikely to follow the study plan or who are likely to be lost to follow-up within three years
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.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit
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.