Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Maintenance · 1 trial · 1 indication
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).
| Arm | Type | Description |
|---|---|---|
| Loading interval group | NO_INTERVENTION | patients who are currently being treated with EYLEA® (aflibercept 2mg) will be switched to EYLEA® HD (aflibercept 8mg) and receive injections every month for the first 3 months followed by an extension (or increase in dosing interval) of therapy based on clinical response. This is the "on label" treatment regimen approved by Health Canada. |
| Maintenance interval group | EXPERIMENTAL | 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. This is the "off-label" treatment regimen that we are testing to see if it is as effective and involves less treatment burden. |
| Name | Type | Description |
|---|---|---|
| Maintenance | OTHER | 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 |
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: * Patie...
Maintenance is an investigational treatment being studied for Wet Age-related Macular Degeneration (wAMD), a condition that causes rapid vision loss due to abnormal blood vessel growth under the retina. It is currently in Phase 3 clinical development, meaning it has not yet been approved by regulatory authorities.
Maintenance is being developed by Bayer AG, a multinational pharmaceutical company traded under the ticker BAYRY. The company is conducting a Phase 3 clinical trial to evaluate the treatment in patients with Wet Age-related Macular Degeneration (wAMD).
Maintenance is currently in Phase 3 clinical development. It is being studied in a randomized, open-label trial that is not yet recruiting participants. The drug remains investigational and has not been approved for commercial use.
Maintenance is being evaluated in a single Phase 3 clinical trial registered as NCT07129239, titled "High Dose (HD) Aflibercept Switch in Neovascular Age-related Macular Degeneration (nAMD): to Load or Maintain (HEIRLOOM)." The trial is planned to enroll 180 participants in Canada and is not yet recruiting.
Maintenance is being studied in a trial that involves switching to high-dose aflibercept, but the drug itself is not identified as aflibercept. The trial compares treatment strategies, including whether to load or maintain dosing, in patients with Wet Age-related Macular Degeneration (wAMD).