Study of Intravitreal LFG316 in patients with multifocal choroiditis

• Research type

  Research Study

• Full title

  A randomized, active-controlled, open-label, multiple-dose, proof-of concept study of intravitreal LFG316 in patients with active non-infectious intermediate-, posterior-, or panuveitis requiring systemic immunosuppressive therapy

• IRAS ID

  96688

• Contact name

  Andrew Dick

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2011-003254-90

• Research summary

  LFG316 is a human monoclonal antibody, which binds to a part of the "C5" complement system in order to reduce the inflammation caused by multifocal choroiditis. Multifocal choroiditis is a chronic disease that involves inflammation in one or both eyes. Despite the current standard therapies (local steroids and other systemic immunosuppressants), permanent vision loss remains common in patients suffering from multifocal choroiditis. Considering these unmet needs in MFC, this study will attempt to evaluate if LFG316 may be beneficial in MFC. The purpose of this clinical trial is to assess if LFG316 may be effective in reducing the inflammation in patients with active "multifocal choroiditis and panuveitis". This study is randomised, active-controlled and open-label. Up to 24 patients with multifocal choroiditis and active vitritis will be enrolled and randomized in a 2:1 ratio to receive intravitreal LFG316 (3 monthly doses of 5 mg) or standard of care (at the Investigator's discretion). The rationale for conventional therapy rather than a comparator is that to date there is no consensus on the most appropriate treatment for MCF. Only one eye (called the study eye) will be treated. During the entire course of the study, the untreated eye (called the fellow eye) will be examined and treated at the investigator's discretion. There will be 8 visits over 16 weeks. Efficacy assessments (eye exams, photos anflurescein angiography) will be conducted by personnel masked to the treatment assignment. This study will be conducted at ocular inflammation specialty clinics in the US and UK. There will be 2 sites in the UK.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  12/SW/0084

• Date of REC Opinion

  14 May 2012

• REC opinion

  Further Information Favourable Opinion