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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• Patients over the age of 18
• Patients with neovascular AMD
• Patients who have received aflibercept 2mg for a minimum of 3 loading injections plus 2 maintenance injections.
• Can include 1 or 2 eyes per patient if one or both meet study criteria.

🚫 You may not be able to join if…

• Patients with other maculopathy, including but not limited to:
• Polypoidal choroidal vasculopathy
• Macular dystrophies (ie. Pattern dystrophy, central areolar etc.)
• Toxic/drug induced maculopathies
• Disciform scar
• Subfoveal atrophy
• Previous Photodynamic Therapy (PDT) or focal laser
• Is currently enrolled in another clinical study or observational study
• Active use of a different agent in the fellow eye, to avoid cross-over effects of anti Vascular Endothelial Growth Factor (VEGF) administration to the fellow eye
• If the patient is pregnant

Where this trial is running

• Clinique de Retine de L'Est, Montreal, Quebec, Canada

Who to contact

Cynthia lacasse · 5143205045 · clacasse.retinedelest@gmail.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07129239.