Wet Age-related Macular Degeneration (wAMD)
Conditions
Brief 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.
Interventions
OTHERMaintenance
Patients 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
Sponsors
Bayer
Clinique de Retine de l'est
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central Retinal Thickness (CRT) | 6 and 12 month | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | 6 and 12 month | 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. |
| Adverse events | 6 and 12 month | 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) | 6 months and 12 months | 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). |
| Number of injections | 6 and 12 month | duration between last injection at 6 months and 12 months from date of the switch measured |
| Pigment Epithelial Detachment (PED) Type | 6 months and 12 months | Morphology and type of PED 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). |
| Pigment Epithelial Detachment (PED) Height | 6 months and 12 months | This outcome measure will be derived from Optical Coherence Tomography (OCT), measured in um, and measured at 12 months after switching therapies with interim analysis at 6 months (Detected on 8 line radial scans, through the fovea). |
| Presence of Intraretinal Fluid (Yes/No) | 6 months and 12 months | 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). |
Countries
Canada
Contacts
Primary ContactCynthia lacasse
Outcome results
None listed