BI 1026706 and placebo in patients with diabetic macular edema.

• Research type

  Research Study

• Full title

  A randomized, double-masked, placebo-controlled exploratory study to evaluate pharmacodynamics, safety and tolerability of orally administered BI 1026706 for 12 weeks in patients with mild visual impairment due to center-involved diabetic macular edema (DME)

• IRAS ID

  199167

• Contact name

  Geeta Menon

• Contact email

  Geeta.Menon@fhft.nhs.uk

• Sponsor organisation

  Boehringer Ingelheim

• Eudract number

  2015-003529-33

• Duration of Study in the UK

  0 years, 10 months, 1 days

• Research summary

  This is a randomized, double-masked, placebo-controlled exploratory study to evaluate pharmacodynamics, safety and tolerability of orally administered BI 1026706 for 12 weeks in patients with mild visual impairment due to center-involved diabetic macular edema (DME). It is estimated that approximately 100 patients with DME will participate worldwide in this trial in about 8 countries. Patients will be randomly assigned to receive either the investigational drug BI 1026706 or placebo. Each patients participation in the trial will last approximately 4.5 months and will require approximately 6 visits to the trial clinic.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  16/LO/1001

• Date of REC Opinion

  5 Sep 2016

• REC opinion

  Further Information Favourable Opinion