GR41987 (Rhone-X) - Long Term Extension study of Faricimab in DMO
Research type
Research Study
Full title
A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF FARICIMAB IN PATIENTS WITH DIABETIC MACULAR EDEMA
IRAS ID
284781
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceutical Division, PDR
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2020-000402-29
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 10 months, 18 days
Research summary
Research Summary
Diabetic macular oedema (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 partial loss of 10 or more letters in visual acuity (VA) within 2 years in approximately 50% of patients.\n\nThe 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.\n\nNew treatments that target additional pathways and lead to reduced burden of IVT injections are needed to address high unmet medical need in DMO.\n\nThis long-term extension (LTE) study will evaluate the long-term safety, tolerability, and efficacy of faricimab 6mg administered by intravitreal (IVT) injection at a personalized treatment interval (PTI) in patients with DMO who have completed either of the Phase III (GR40349 or GR40398) parent studies. Eligible patients who choose to enroll into the LTE study will have monthly, masked, study visits for the first 4 months of the study, followed by an open-label design in which participants will only be required to attend study visits at which faricimab is to be administered, at intervals determined according to the PTI algorithm. Additional assessments relating to pharmacokinetics, immunogenicity, and biomarkers will be performed.\n\nApproximately 1800 participants will take part in this Long-term extension study globally, with an anticipated 56 UK participants, being recruited from 18 participating centres.\n\nThe study is sponsored by F. Hoffman La Roche\n
Summary of Results
: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fforpatients.roche.com%252Fen%252Ftrials%252Feye-disorder%252Fdme%252Fa-study-to-evaluate-the-long-term-safety-and-tolerabili-41480.html%2523forpatients%2FNBTI%2FpLy6AQ%2FAQ%2F8d479e5c-ce4d-4b1c-9dc0-557788534fa3%2F1%2Fo2DiQtuPtF%23forpatients&data=05%7C02%7Cleedseast.rec%40hra.nhs.uk%7C331d2fda4b924c75f8ba08dd361aaffa%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638726210421752885%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=qP1TQidLw4Zxdx1aKeqKkWxp2fgKkD02EwxKMK1ur58%3D&reserved=0
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
20/YH/0231
Date of REC Opinion
10 Sep 2020
REC opinion
Further Information Favourable Opinion