The LIMO Study, Lucentis for Treatment of Uveitic Patients With Refractory Cystoid Macular Oedema
Condition: Uveitis Related Cystoid Macular Edema; Steroid-induced Glaucoma - Borderline
MeSH terms: Macular Edema; Uveitis; Edema
Study type: Interventional
Phase: Phase 2

Summary: 
      Anti-vascular endothelial growth factor (VEGF) treatments show great promise in the treatment
      of a variety of retinal diseases. This study addresses a condition which affects a large
      number of our patients in whom the investigators face difficult management decisions. These
      patients with uveitis are severely disabled with visual loss related to cystoid macular
      oedema (CMO) and few options remain when standard treatment has either failed or is
      contraindicated.

      The concentration of VEGF is increased in the eyes of patients with uveitis. Our hypothesis
      is that a series of injections of Ranibizumab may be an effective treatment for CMO. It is
      hoped that anti-VEGF therapy will have fewer side-effects than existing therapies and will be
      more effective in improving quality of life by reducing macular thickening and restoring
      visual function.
    

Detailed description: 
      The study has been designed as an open label, prospective non-randomised interventional case
      series.

      Clinical staff will be asked to briefly discuss the option of enrolling into the study with
      potentially suitable patients. If the patient expresses an interest in finding out more about
      the study, the doctor will then contact a member of the study team, who will provide the
      patient with the patient information leaflet. This outlines the details and purpose of the
      study, the intended benefits of the intravitreal treatment and the potential hazards
      (including the unlicensed use of Ranibizumab for this indication). The intravitreal injection
      procedure will be discussed. The follow-up schedule will be outlined. There will be an
      opportunity for the patient to ask questions and at least 24 hours for the patient to think
      about entering the study. Only 1 eye of each patient, the worse eye, will be enrolled.

      Comprehensive pre- and post- therapy and a longitudinal series of structure and function
      tests will be performed on all 20 enrolled patients. All patients will receive intravitreal
      injections performed in a designated clean room. The injections (Ranibizumab 0.5 mg in 0.05
      ml) will be administered 4-5 weekly, for three injections then according to clinical need for
      a total of 12 months of follow-up. A maximum of 5 intravitreal Ranibizumab injections will be
      administered to patients who do not demonstrate any positive clinical response.

      The patients will be seen for baseline screening over a 2 day period, with the first
      treatment with Ranibizumab administered on the second day (maximum of 10 working days after
      the first baseline screening day). Subsequent to the first 3 injections, the investigator
      will assess whether re-treatment is warranted (clinical / OCT criteria set out in
      re-treatment protocol). Re-treatment, when indicated, will be performed on the same day as
      the follow-up visit and no sooner than 4 weeks or later than 5 weeks from the time of the
      last treatment. If re-treatment with IVI Ranibizumab is to be deferred patients will not be
      given a sham injection. Should a relapse in ocular inflammation occur, it might be difficult
      to differentiate as to whether this is because of the drug or the underlying disease. A mild
      flare up, Lucentis-related or not, may be observed and treated with topical therapy (but
      patient will remain in the study). A moderate to severe recurrence, regardless of the cause
      which will necessitate more extensive therapy, namely a change or addition of systemic
      therapy, will result in the patient exiting the study-this would be an end point.
    

Intervention name(s): Ranibizumab
Intervention type(s): Drug
Intervention description(s): Series of intravitreal injections of Ranibizumab
Other intervention name(s): Lucentis
Intervention MeSH terms: Ranibizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intravitreal Ranibizumab; Non-infectious uveitis; Refractory Cystoid Macular Oedema; Lucentis; LIMO