BI 1467335 in patients with diabetic retinopathy.

• Research type

  Research Study

• Full title

  A randomized, double-masked, placebo-controlled exploratory study to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics of orally administered BI 1467335 for 12 weeks with a 12 week follow up period in patients with non proliferative diabetic retinopathy without centre-involved diabetic macular edema.

• IRAS ID

  230501

• Contact name

  Sobha Sivaprasad

• Contact email

  Sobha.Sivaprasad@moorfields.nhs.uk

• Sponsor organisation

  Boehringer Ingelheim Ireland Ltd

• Eudract number

  2016-002971-91

• Clinicaltrials.gov Identifier

  NCT03238963

• Duration of Study in the UK

  0 years, 11 months, 14 days

• Research summary

  This study is a randomized, double-masked, placebo-controlled exploratory study to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics of orally administered BI 1467335 for 12 weeks with a 12 week follow up period in patients with nonproliferative diabetic retinopathy without center-involved diabetic macular edema.
  The objectives of the study are to compare the safety and effects of BI 1467335 with a placebo. Each patient will either get the study drug or a placebo. The study will also measure BI 1467335 in the blood and find out more information about how it works in the body. Each patients participation in this trial will last approximately 30 weeks and require approximately 8 visits to the trial clinic. Patients will be required to undergo a physical examination and ECG, have their vital signs checked, and undergo various ophthalmological tests along with a blood test for safety, Pharmacokinetics and Pharmacogenetic analysis. Patients will be asked to consent for an optional additional blood sample for biobanking.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  17/YH/0392

• Date of REC Opinion

  26 Jan 2018

• REC opinion

  Further Information Favourable Opinion