GR41986 - COMINO

• 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 CENTRAL RETINAL OR HEMIRETINAL VEIN OCCLUSION

• IRAS ID

  283679

• Contact name

  Michael Williams

• Contact email

  m.williams@qub.ac.uk

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Eudract number

  2020-000441-13

• Clinicaltrials.gov Identifier

  NCT04740931

• Duration of Study in the UK

  2 years, 5 months, 6 days

• Research summary

  Summary of Research
  Central retinal vein occlusion (CRVO) and Hemiretinal Vein Occlusion (HRVO) can cause Macular Oedema i.e when fluid gathers in the central part of the retina, inside the eye. CRVO or HRVO is more common with advancing age, and has been associated with some conditions including diabetes and high blood pressure. It can cause various degrees of visual loss, and the most common cause of visual loss following CRVO or HRVO is MO.

  The treatment of CRVO or HRVO has been improved by anti-vascular endothelial growth factor (anti-VEGF) agents. In general, these drugs are safe and effective in preventing further visual loss due to MO, 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 - This phase III study will compare the effects of intravitreal injections of faricimab versus intravitreal injections of aflibercept on patents with MO

  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 at 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 680 people will take part in the study around the world, including approximately 30 people from 10 UK hospitals.

  The study is sponsored by F. Hoffman La Roche

  Research Summary; Version Number 1.0, dated 17-Jun-2020.

  Summary of Results
  https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fforpatients.roche.com%252Fen%252Ftrials%252Feye-disorder%252Frvo%252Fa-study-to-evaluate-the-efficacy-and-safety-of-faricima-34453.html%2FNBTI%2Fmwa5AQ%2FAQ%2F99e20b08-8202-4cf4-abdf-0e5a3aa7a361%2F1%2FjCdYYLJwVP&data=05%7C02%7CWales.REC2%40wales.nhs.uk%7C7f1293e2e3334b271df308dcfdb465a7%7Cbb5628b8e3284082a856433c9edc8fae%7C0%7C0%7C638664200814976465%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=ajsWyTbMxC8zecGGuK8xMiGnUWRHICcINwgmTVtEIbg%3D&reserved=0

• REC name

  Wales REC 2

• REC reference

  21/WA/0008

• Date of REC Opinion

  9 Feb 2021

• REC opinion

  Further Information Favourable Opinion