Clinical Trial

High Dose (HD) Aflibercept Switch in Neovascular Age-related Macular Degeneration (nAMD): to Load or Maintain (HEIRLOOM)

Study acronym: HEIRLOOM
Not Yet Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The purpose of this study is to compare two treatment frequencies using EYLEA® HD (aflibercept 8mg) in patients with wet age-related macular degeneration (wAMD) that are currently treated with EYLEA® (aflibercept 2mg). EYLEA® HD is approved by Health Canada has been tested in large clinical trials involving thousands of patients around the world and has been shown effective in the treatment of wAMD. The treatment regimen used in these trials involved 3 initial monthly injections of EYLEA® HD followed by an extension of the treatment interval on the 4th visit. This was necessary since all patients in this study did not previously have treatment injections for wAMD. Currently there is not enough information on the best treatment regimen to use for patients that are switched to EYLEA® HD from EYLEA®. Health Canada currently recommends that EYLEA® HD is administered every month for the first 3 doses, followed by a treatment every 8 to 16 weeks. A total of 180 patients \>18 years of age will participate in this study, which will be conducted at the Clinique de Retine de l'Est in Montreal, Quebec, Canada.
Trial Details
NCT Number NCT07129239
Lead Sponsor Clinique de Retine de l'est
Collaborators: Bayer
Conditions Wet Age-related Macular Degeneration (wAMD)
Enrollment 180 participants
Start Date 2025-08-20
Primary Completion 2027-02 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2025-08-19