SINGLE ASCENDING DOSE Study of RO6867461 in wAMD

• Research type

  Research Study

• Full title

  A MULTIPLE-CENTER, NON-RANDOMIZED, OPEN LABEL,SINGLE-ASCENDING-DOSE, PARALLEL STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RO6867461 FOLLOWING INTRAVITREAL ADMINISTRATION IN PATIENTS WITH WET AGE-RELATED MACULAR DEGENERATION.

• IRAS ID

  137769

• Contact name

  Usha Chakravarthy

• Contact email

  U.Chakravarthy@qub.ac.uk

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Eudract number

  2013-001972-40

• ISRCTN Number

  N/A

• Research summary

  The purpose of the study is to understand the safety and tolerability of RO6867461 a new compound which will be used to treat wet age-related macular degeneration (AMD). The study will include clinical sites in the USA and UK. The study will enrol persons aged 50 years and over who have a confirmed diagnosis of AMD. This is the first study in which RO6864761 will be administered to humans.
  Patients will be enrolled in sequence into a dose group and there will be a step wise increase in dose allowing for safety assessment of RO6867461. A minimum of 3 patients will be assigned in each group before moving on to the next dosing level.RO6867461 will be administered intravitreally on Day 1 and patient will be followed up for next 12 weeks. The patient’s safety and tolerability to drug will be assessed by ocular examination (clinical and through non-invasive scans), recording of adverse events and analysis of blood samples for laboratory and or clinical abnormalities.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  13/NE/0294

• Date of REC Opinion

  28 Oct 2013

• REC opinion

  Further Information Favourable Opinion