XPAND

• Research type

  Research Study

• Full title

  A Parallel-group Phase 4, Open-label, Two-arm Study to Assess the Safety and Efficacy of Intravitreal (IVT) Aflibercept with Proactive customized Treatment Intervals in Patients ≥50 Years of Age with No Fluid Due to Choroidal Neovascularization (CNV) Lesions Secondary to Neovascular (wet) Age-related Macular Degeneration (nAMD) Following Treatment Initiation with Aflibercept

• IRAS ID

  1006101

• Contact name

  Helmut Allmeier

• Sponsor organisation

  Bayer AG

• Eudract number

  2022-000690-73

• Clinicaltrials.gov Identifier

  NCT05473715

• Research summary

  The study treatment intravitreal aflibercept is injected into the eye. It has already been approved for patients with wet AMD to be given as intravitreal injection monthly at start (3 x) and then every 8 weeks or longer. Doctors try to increase the time between injections (treatment interval) in routine clinical practice based on individual patient needs. This is called treat and extend (T&E). Treatment intervals are stepwise extended or shortened depending on how the treatment works. This is checked with optical coherence tomography (OCT), an imaging technique used to observe relevant changes in the eye.
  The main purpose of this study is to learn how well aflibercept works if treatment intervals are extended faster, compared to standard T&E regimen in people with wet AMD in a preselected patient population with no fluid after treatment initiation. Changes in vision between study start and after 36 weeks will be assessed and compared between participants whose treatment intervals were extended early and those on standard T&E regimen. All participants will receive 2 mg aflibercept as intravitreal injection for up to 52 weeks in intervals of every 4 to 16 weeks.
  Each participant will be in the study for up to 56 weeks. During this time 4 visits to the study site are set for all participants. The other visits are set individually if necessary. Doctors will:
  • check patients’ eye health using various standard eye examination techniques
  • measure patients’ eye vision
  • do physical examinations
  • check vital signs
  • ask the participants questions about how they are feeling and what adverse events they are having.
  An adverse event is any medical problem that a participant has during a study. In addition, participants in the fast extension arm will be provided with a home monitoring OCT device for self-monitoring.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  22/LO/0654

• Date of REC Opinion

  13 Dec 2022

• REC opinion

  Further Information Favourable Opinion