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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinique de Retine de l'est

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Polypoidal choroidal vasculopathy

Macular dystrophies (ie. Pattern dystrophy, central areolar etc.)

Toxic/drug induced maculopathies

Disciform scar

Trial design

Treatments tested in this trial

  • Maintenance

Treatment groups

180 Participants
are divided into 2 treatment groups

Sponsors and collaborators