MR41926 An exploratory study in patients with diabetic macular oedema

• Research type

  Research Study

• Full title

  AN EXPLORATORY, PROSPECTIVE, MULTI-CENTER, OPEN-LABEL, SINGLE-ARM, INTERVENTIONAL, PHASE IIB STUDY TO INVESTIGATE AQUEOUS HUMOR AND MULTIMODAL IMAGING BIOMARKERS IN TREATMENT-NAÏVE PATIENTS WITH DIABETIC MACULAR EDEMA TREATED WITH FARICIMAB (RO6867461) - ALTIMETER STUDY

• IRAS ID

  289482

• Contact name

  Head, EU/ROW Regulatory Affairs Pharmaceutical Division, PDR

• Contact email

  global.eudract@roche.com

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Eudract number

  2020-001174-30

• Clinicaltrials.gov Identifier

  NCT04597918

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  1 years, 4 months, 25 days

• Research summary

  Study MR41926 is an exploratory, prospective, multicenter, open-label, single-arm, interventional, Phase IIb study designed to explore the associations over time between clinical assessments, multimodal imaging assessments, aqueous humor (AH) biomarker patterns, and genetic polymorphisms in patients with diabetic macular oedema who are treated with faricimab.
  State-of-the-art imaging technologies and new immunoassay platforms will be utilised in this study. Advanced analytics and multivariate analysis will also be used to show the relationships between aqueous humour and imaging biomarkers as well as genetic polymorphisms.
  •Aqueous Humour taps from the study eye will be collected on Day 1 (baseline) and the Day 112 visit (i.e., prior to injections 1 and 5).
  •Multimodal retinal imaging will be applied at the screening visit, Day 1 (baseline), and throughout the study
  Patients will receive 6 doses (one 6 mg faricimab intravitreal [IVT] injection every 28 days [Q4W]) starting at Day 1 and ending on the Day 140 visit. Patients will return for a safety follow up visit (SFV) after ≥28 days and within <35 days following their last study treatment.
  80 patients will be recruited globally. There will be approximately 12 patients recruited at 4 UK sites

  The study is sponsored by F. Hoffman La Roche
  Research Summary; Version Number 1 2nd December 2020

• REC name

  London - Brent Research Ethics Committee

• REC reference

  21/LO/0111

• Date of REC Opinion

  1 Mar 2021

• REC opinion

  Further Information Favourable Opinion