An Investigation of LFG316 in Patients with AMD

• Research type

  Research Study

• Full title

  A multiple dose, two-cohort study to assess the safety,tolerability, pharmacokinetics, pharmacodynamics, and efficacy of intravenous LFG316 in patients with neovascular age-related macular degeneration

• IRAS ID

  114595

• Contact name

  Clare Bailey

• Sponsor organisation

  Novartis A.G

• Eudract number

  2012-004244-29

• ISRCTN Number

  To be applied for

• Research summary

  The purpose of this study is to investigate a drug called LFG316 and to assess how safe and well tolerated this drug is when administered intravenously (into the vein) in patients suffering from Age-related Macular Degeneration (AMD). The study will also look at how quickly LFG316 enters the bloodstream and the effect it has on the body in order to find out if the drug is acting as it should. Age-related macular degeneration (AMD) is a common eye condition in people aged 50 or older.It is the most common cause of vision loss in older adults. It gradually destroys the part of the eye that provides sharp, detailed, central vision that allows us to see objects clearly. This part of the eye is called the macula. The population who are eligible to take part in the study are male or female AMD patients aged between 55 and 90 years of age. The study will take place at the Retinal Treatment and research Unit, bristol Eye Hospital. The study will be conducted as 2 groups; Group 1, which will be made up of between 4-8 patients and; Group 2, which will be made up of between 39-51 patientsBoth Group 1 and 2 will consist of at least 1 visit to the hospital formscreening tests to be performed, a treatment period of approximately 85 days which consists of multiple out-patient visits and an end of study visit approximately 113 days after the first treatment.

• REC name

  Wales REC 2

• REC reference

  12/WA/0392

• Date of REC Opinion

  18 Mar 2013

• REC opinion

  Further Information Favourable Opinion