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A Study of LX211 in Active Sight Threatening, Non-Infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis (LUMINATE)

This is a new treatment. You can read an information sheet below and more details of this trial in the UK can be obtained by contacting Mr Pavesio (see also other UK centres at bottom of this page). There are 3 separate trials and links to detailed info of each can be found further down this page

LUMINATE clinical trial program       Information for Patients

 The LUMINATE (Lux Uveitis Multi-center Investigation of a New Approach to TrEatment) Phase II/III clinical trial program sponsored by Lux Biosciences is the first industry-sponsored program for the approval of a drug that, by affecting the immune system, helps to decrease the amount of steroids needed to treat, maintain and control non-infectious uveitis.

 Background:

The standard systemic immunosuppressive medications used for patients with either active sight threatening or clinically quiescent sight threatening, non infectious uveitis can cause significant toxic side effects, especially with prolonged use. LX211 is a potent calcineurin inhibitor that appears to be well-tolerated. Clinical trials of LX211 have demonstrated efficacy in T-cell mediated conditions comparable to non-infectious uveitis, such as the prevention of rejection in transplant patients and the treatment of plaque psoriasis.

 The LUMINATE clinical trial program in uveitis consists of three controlled studies that will enroll more than 500 patients worldwide. One of the aims of these studies is to determine what treatment is best.  Patients will be randomly assigned to receive one of four different treatments.  These trials are “double masked” trial, meaning that neither the patients nor their research doctors will know to which treatment a patient has been assigned.

·         LUMINATE - Active (LX211–01) investigates the use of LX211 as a means to decreasing the amount of steroids needed in the treatment of active posterior, intermediate and panuveitis        
                            click here for detailed info sheet                           

·         LUMINATE - Maintenance (LX211–02) investigates the use of LX211 to maintain control of inflammation in patients with quiescent posterior, intermediate and panuveitis

·         LUMINATE - Anterior (LX211–03) investigates the use of LX211 as a steroid-sparing agent in the treatment of patients with active anterior chamber inflammation

For detailed patient info sheets of the above 3 studies can be downloaded in Word or pdf files by clicking on the links below:

Study	word file	pdf file
LUMINATE - Active (LX211–01)	click here	click here
LUMINATE - Maintenance (LX211–02)	click here	click here
LUMINATE - Anterior (LX211–03)	click here	click here

 Qualified participants may be male or female and at least 18 years of age and cannot presently have any non-ocular unrelated conditions that require immunosupression. In addition, patients:

·         Must not be seropositive for human immunodeficiency virus (HIV)

·         May not have active syphilis, Lyme Disease or toxoplasmosis

·         May not have been a recipient of a solid organ transplant

·         Should not be planning to undergo elective ocular surgery during the study

 Qualified participants will be randomized to receive the study medication or placebo and study related care for up to six months. Patients who are stable at the end of six months will be offered the opportunity to remain on treatment for a minimum of six additional months.

 If you have uveitis, requiring immunosuppression and especially if you are having problems with the control of your disease or the medications used, you may want to speak to your doctor about these studies. He/she will consider this option with you and decide about a referral to one of the centers conducting the study in the UK.

List Of UK sites (plus study coordinators):

 Moorfields Eye Hospital, London
Mr. Carlos Pavesio
Sally Falk (study Coordinator)
+44 20 7566 2588

 Royal Liverpool University Hospital, Liverpool
Mr. Ian Pearce
Sandy Taylor (Study Coordinator)
+44 151 706 3994

 University of Bristol, Bristol Eye Hospital
Prof. Andrew Dick
Cherry Daly (Study Coordinator)
+44 0117 928 4770

 King's College London, Saint Thomas Campus, Eye Dept.
Prof. Miles Stanford
Sanjeev Heemraz (Study Coordinator)
+44 207 188 4335

Uveitis Information Group is a charity registered in Scotland, no. SCO28439