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.
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.
Polypoidal choroidal vasculopathy
Macular dystrophies (ie. Pattern dystrophy, central areolar etc.)
Toxic/drug induced maculopathies
Disciform scar
Parallel
Maintenance
Other interventionPatients who are currently being treated with EYLEA® (aflibercept 2mg) will be switched to EYLEA® HD (aflibercept 8mg) and maintain the current treatment interval that they had with EYLEA® (aflibercept 2mg), followed by an extension of therapy (or increase in treatment dosing interval) based on clinical response
Central Retinal Thickness (CRT)
The primary endpoint will derived from Optical Coherence Tomography (OCT), in µm and measured at 12 months after switching therapies with interim analysis at 6 months (Detected on 8 line radial scans, through the fovea).
Visual Acuity
Visual acuity measured by the Snellen method and then converted to Early Treatment Diabetic Retinopathy Study (EDTRS) letters. Change in visual acuity will be assessed at 6 and 12 months compared to baseline.
Number of injections
duration between last injection at 6 months and 12 months from date of the switch measured
Adverse events
Will be reported at 6 and 12 months from date of the switch measured by frequency of events (numerical), as well as descriptive for what type of adverse event.
Presence of Subretinal Fluid (Yes/No)
This measure will be derived from Optical Coherence Tomography (OCT), and measured at 12 months after switching therapies with interim analysis at 6 months (Detected on 8 line radial scans, through the fovea).
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Clinique de Retine de l'est
Lead sponsor
Bayer
Collaborator
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