GR40398 EFFICACY AND SAFETY OF RO6867461 IN DMO PATIENTS (RHINE) v1

• Research type

  Research Study

• Full title

  A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, ACTIVE COMPARATORCONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RO6867461 IN PATIENTS WITH DIABETIC MACULAR EDEMA (RHINE)

• IRAS ID

  248599

• 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

  2017-005105-12

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  3 years, 6 months, 9 days

• Research summary

  Research summary - Diabetic macular oedma (DMO) is a chronic eye disease that can occur in people with diabetes and causes problems in vision, such as blurred or wavy vision and colours that appear to be washed out.

  If left untreated, DMO can lead to a loss of 10 or more letters in visual acuity (VA) within 2 years in approximately 50% of patients.
  Lay Summary - The Lay summary results was provided to REC on 06 Oct 2022 and it was distributed study participants on 28 Oct 2022.
  Has the registry been updated to include summary results?: No
  If yes - please enter the URL to summary results: results have been submitted to clinicaltrials.gov but not yet published. https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT04432831%253Fterm%253DNCT04432831%2526amp%253Brank%253D1%2526amp%253Btab%253Dresult%2FNBTI%2FUFW1AQ%2FAQ%2F873b2c8a-4376-4e62-9027-e5f009eaa75a%2F1%2FwUQkNwnOUh&data=05%7C02%7Cbrightonandsussex.rec%40hra.nhs.uk%7Cc93a6a1b548c452f8af908dc74dae728%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638513730735118194%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=C4Si6BrCRpdbVNuHbIcadkbEQlqA7Z%2B6i0AYXP1Zvas%3D&reserved=0 s

  It is caused by damage to blood vessels in the retina that allows the vessels to leak fluid into the macula (the part that gives sharp vision), making it swell and leading to vision problems.

  RO6867461 blocks two important pathways that are thought to be involved in diabetic eye disease: vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2).

  Currently available anti-VEGF therapies for DMO include ranibizumab and aflibercept. The current standard of care for administration of anti-VEGF injections requires patients to undergo frequent clinical examinations and intravitreal (IVT) injections. This imposes a significant burden on patients, caregivers, treating physicians, and the healthcare system. New treatments that target additional pathways and lead to reduced burden of IVT injections are needed to address high unmet medical need in DMO.

  This is Phase III, double-masked, multicentre, randomized, active comparator-controlled, parallel-group study, evaluating the efficacy, safety, pharmacokinetics, and optimal treatment frequency of RO6867461 administered by intravitreal (IVT) injection at 8-week intervals or personal treatment interval of approximately 100 weeks' duration (excluding the screening period) to patients with DMO.

  Approximately 900 patients will be randomized into the study globally in a 1:1:1 ratio to one of three treatment arms (RO6867461 or comparator Q8W, or RO6867461 in a personalised treatment dosing regimen).

  In the UK, it is anticipated that 120 patients will be recruited from 20 participating centres.

  The study is sponsored by F. Hoffman La Roche

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  18/LO/1311

• Date of REC Opinion

  31 Aug 2018

• REC opinion

  Further Information Favourable Opinion