GR41984 - BALATON

• Research type

  Research Study

• Full title

  A PHASE III, MULTICENTER, RANDOMIZED,DOUBLE-MASKED, ACTIVE COMPARATOR CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FARICIMAB IN PATIENTS WITH MACULAR EDEMA SECONDARY TO BRANCH RETINAL VEIN OCCLUSION

• IRAS ID

  283678

• Contact name

  Michael Williams

• Contact email

  m.williams@qub.ac.uk

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Eudract number

  2020-000440-63

• Clinicaltrials.gov Identifier

  NCT04740905

• Duration of Study in the UK

  2 years, 5 months, 6 days

• Research summary

  Summary of Research
  Branch retinal vein occlusion (BRVO) can cause macular oedema (MO), i.e. when fluid gathers in the central part of the retina, inside the eye. BRVO is common with advancing age, and has been associated with conditions including diabetes and high blood pressure. It can cause various degrees of visual loss, and the most common cause of visual loss following a BRVO is MO.

  The treatment of BRVO has been improved by a class of drugs called anti-vascular endothelial growth factor (anti-VEGF) agents. In general, these drugs are safe and effective in preventing further visual loss due to MO after a BRVO, or improving vision. However, they need to be given frequently, which imposes a burden on both patients and the health service.

  Faricimab is a new experimental drug that blocks two important mediators, VEGF and angiopoeitin thought to be important in causing MO following a BRVO: - This phase III study will compare the effects of intravitreal injections of faricimab versus intravitreal injections of aflibercept on patents with MO due to BRVO.

  The study has 3 main parts:
  - Screening – to see if you are eligible to participate
  - Treatment Part 1 (weeks 1-20) - Participants will receive either faricimab or aflibercept every 4 weeks.
  - Treatment Part 2 (weeks 24-68) – Participants will receive faricimab given at personalized dosing intervals

  At week 72 after treatment is completed, all participants will receive a follow-up visit in hospital.

  Participants can expect to be in the study for a total time of 18 months. The total length of the study from screening to the last patient’s last visit from global enrollment is expected to be approximately 34 months.

  Approximately 520 people will take part in the study around the world, including approximately 20 people from 7 UK hospitals.

  The study is sponsored by F. Hoffman La Roche

  Research Summary; Version 1.0, dated 23-Jun-2020.

  Summary of Results
  This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in participants with macular edema due to branch retinal vein occlusion (BRVO).

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  21/YH/0012

• Date of REC Opinion

  1 Feb 2021

• REC opinion

  Further Information Favourable Opinion