MUST FS

• Research type

  Research Study

• Full title

  Long-term Follow-up Patients Who Participated in the Multicentre Uveitis Steroid Treatment Trial (MUST Trial Follow-up Study)

• IRAS ID

  81239

• Contact name

  Sue Lightman

• Sponsor organisation

  National Intitute of Health, National Eye Institue

• Eudract number

  2011-001078-25

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  Uveitis is an inflammation inside the eye which can result in decrease in vision and can cause blindness. This trial is to be seen as a long term follow-up study to the Multicentre Uveitis Steroid Treatment (MUST) trial which is currently ongoing. Only patients who have previously been enrolled in the MUST trial will be invited to participate in this trial. Both trials are using the same investigational medicinal product. The main purpose of this trial is to investigate which one out of two different uveitis treatments give the best result over a six years period. The two different treatments to be investigated are A) a local implant filled with a corticosteroid medicine calleflucinolone acetonide which is inserted into the affected eye and B) corticosteroid tablets together with, if deemed necessary, other immunosuppressive medicines which are taken orally. During the trial the patients that volunteer to participate in this study will be seen twice a year. During these study visits the patients eyes will be examined by a study doctor, the patient weight will be recorded, their blood pressure will be measured and the patients will fill out questionnaires on how they are feeling. Further, once a year the patients?? eyes will be photographed and another type of imaging called optical coherence tomography (OCT), will also be taken. OCT test is like an ultrasound of the eye, except it uses light instead of sound waves. Safety blood samples will be taken at least annually or more often depending on what treatment the patient is on. Height will be measured annually. This is supposed to be a multicentre trial with MUST centres located in United States of America, one centre in Australia and one centre in England. No new centres will be recruited.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  11/EE/0368

• Date of REC Opinion

  25 Oct 2011

• REC opinion

  Further Information Favourable Opinion