MR45638 - A STUDY OF FARICIMAB INVESTIGATING EXTENDED TREATMENT INTERVALS IN PATIENTS WITH nAMD

• Research type

  Research Study

• Full title

  A PHASE IIIB/IV, MULTICENTER, RANDOMIZED, OPEN-LABEL, TWO-ARM STUDY TO INVESTIGATE THE EFFICACY, SAFETY, AND DURABILITY OF FARICIMAB ADMINISTERED UP TO EVERY 24 WEEKS IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (CONSTANCE)

• IRAS ID

  1011152

• Contact name

  Shady Mansour

• Contact email

  welwyn.uk_ethics@roche.com

• Sponsor organisation

  F. Hoffmann- La Roche AG

• Eudract number

  2024-517545-13

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  NCT06795048

• Research summary

  The purpose of this study is to evaluate the efficacy, safety, and durability of intravitreal (IVT) 6-mg faricimab administered at up to 24-week intervals in patients with macular neovascularization (MNV) secondary to age-related macular degeneration (nAMD) in patients who are treatment-naïve in the study eye.
  nAMD is a form of advanced AMD that causes rapid and severe visual loss and remains a leading cause of visual impairment in older individuals.
  Previous studies showed that faricimab, given at intervals of up to 4 months, offered non-inferior vision gains compared with aflibercept, given every 2 months. Furthermore, patients receiving faricimab given at intervals of up to 4 months experienced good disease control.
  Previous studies therefore demonstrate the ability of faricimab to address the clear unmet need for less frequent dosing with sustained efficacy in nAMD.
  This study will explore the potential for patients receiving faricimab to be treated at less frequent intervals of every 20 weeks and every 24 weeks.
  In this open label study , after an initial loading period, participants will only be required to attend study visits at which faricimab is to be administered and certain mandatory visits.
  The study consists of a screening period and an approximately 100-week study period.
  Participants will be randomized 1:1 to one of the following two treatment arms:
  Arm A: Two loading doses 4 weeks apart, followed by a T&E regimen where dosing interval can range from Q4W to Q24W, adjusted in 4-week increments.
  Arm B: Four loading doses 4 weeks apart, followed by every 8 weeks, every 12 weeks, or every 16 weeks treatment based on disease activity at Weeks 20 and 24, and a T&E regimen starting as early as Week 28.
  Approximately 29 patients will be recruited at 7 UK sites
  The study is sponsored by F. Hoffmann-La Roche Ltd
  Research Summary; Version Number 1, 03-Dec- 2021

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  25/SC/0121

• Date of REC Opinion

  14 May 2025

• REC opinion

  Further Information Favourable Opinion