Phase 3 Uveitis Trial, Completed

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

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 the consent form
• People who have had recurring non-infectious inflammation inside one or both eyes (affecting the back of the eye, with or without front-of-eye involvement) for more than 1 year
• People whose study eye has a low level of inflammation at the time of joining (fewer than 10 inflammatory cells visible in the front of the eye, and only mild cloudiness in the jelly-like substance at the back of the eye)
• People whose study eye has a minimum level of vision, measured as at least 15 letters on a standard eye chart used in research settings
• People who are not planning to have any optional eye surgery during the study period
• People who are able to understand and sign a consent form
• People who are willing and able to attend scheduled visits, follow the treatment plan, and complete all required tests and procedures
• People whose study eye, in the 12 months before joining, either received treatment (such as steroid tablets or other medicines taken by mouth for at least 3 months, and/or at least 2 steroid injections into or around the eye), OR experienced at least 2 separate flare-ups of eye inflammation requiring steroid treatment (by mouth or injection into or around the eye)

Who may not be able to join:

• People with a known allergy to fluocinolone acetonide or any ingredient in the implant being studied
• People whose eye inflammation history only involves the back of the eye, with no inflammation of the jelly inside the eye and no swelling at the centre of the retina
• People whose eye inflammation history only involves the front of the eye (iris), with no signs of inflammation elsewhere in the eye
• People whose eye inflammation is caused by an infection
• People who have bleeding inside the eye (vitreous hemorrhage)
• People whose eye inflammation is caused by a condition other than non-infectious uveitis (for example, a type of eye cancer called intraocular lymphoma)
• People who have or have had a cancerous growth inside either eye, including a type called choroidal melanoma
• People who have scarring in the study eye from a parasitic infection (toxoplasmosis) or from a previous viral infection of the retina
• People who have previously had a viral infection of the retina
• People who currently have a viral, bacterial (mycobacterial), or fungal infection affecting the surface of the eye or its structures
• People whose view of the back of the eye is blocked by cloudiness in the eye, making proper assessment impossible
• People who have 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 study eye, unless a previous surgical procedure has brought their eye pressure into the normal range (10–21 mmHg) and kept it stable there
• People whose eye pressure in the study eye is above 21 mmHg at screening, or who are currently using any eye-pressure-lowering eye drops in the study eye
• People with persistently very low eye pressure (below 6 mmHg) in the study eye
• People who have had eye surgery on the study eye within 3 months before joining
• People who have had a laser procedure to the lens capsule in the study eye within 30 days before joining
• People who have received a specific long-acting steroid implant (Retisert) in the study eye within the past 36 months
• People who have received a specific steroid implant (Ozurdex) in the study eye within the past 6 months
• People who have received certain steroid injections into the jelly of the study eye (Triesence or Trivaris) within the past 3 months
• People who have received a steroid injection around or near the study eye within the past 3 months
• People who require ongoing high-dose steroid tablets (more than 15mg of prednisone per day) or long-term immune-suppressing medicines taken by mouth
• People who have or have had cancer (other than certain common skin cancers) that is currently being treated or has been in remission for less than 5 years before joining
• People who have tested positive for HIV, tuberculosis, or syphilis
• People who have had a general infection anywhere in the body within 30 days before joining
• People with a serious ongoing physical or mental health condition that, in the doctor's judgement, could make participation risky or affect the study results
• People with any other eye or general health condition that, in the doctor's judgement, makes participation unsuitable
• People who have taken part in another clinical trial involving an experimental medicine or device within the past 30 days
• Pregnant or breastfeeding women, or women who could become pregnant and are unwilling or unable to use an acceptable form of contraception from at least 14 days before joining until the 12-month visit
• People who are considered unlikely to follow the study requirements or to remain contactable for the full three years of the study

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