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
Sponsors and collaborators
Clinique de Retine de l'est
Lead sponsor
Bayer
Collaborator