Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will investigate if switching patients who appear to be sub-optimal responders to the current standard of care treatment with Aflibercept 2mg to Aflibercept 8mg will prolong treatment intervals and maintain visual acuity.
Aflibercept 8 mg was recently approved by the European Medicines Agency (EMA) for the treatment of neovascular age-related macular degeneration (nAMD). The higher dosage promises prolongation of treatment intervals up to 16 weeks. Only limited clinical data is available on switching from so-called suboptimal or non-responders. A retrospective analysis showed that aflibercept in 3 mg or 4 mg doses can improve outcomes in patients who do not respond optimally to aflibercept 2 mg. It remains unclear whether switching to the above-mentioned and newly approved aflibercept 8 mg will prolong treatment intervals and stabilize visual acuity in patients who are not treatment-naive.
The present study is a single-center observational study. The plan is to include 50 eyes from 50 patients who have previously received aflibercept 2 mg injections. Patients receive a routine 8 mg aflibercept injection in the eye clinic based on the existing treat-extend regimen. At each visit, a visual acuity test, optical coherence tomography (OCT) imaging, and a standard slit lamp examination with fundoscopy are performed. The injection interval is extended by two weeks. If the two-week extension leads to deterioration, the interval is shortened by two weeks. Patients are monitored in the study for 12 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neovascular age-related macular degeneration (nAMD) | Patient suffering from neovascular age-related macular degeneration (nAMD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept | Drug | Intravitreal injection with high dose (8 mg) aflibercept |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of intravitreal injections | Total number of intravitreal injections will be assessed over 12 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| corrected distance visual acuity (CDVA) | CDVA will be determined using ETDRS-charts in a distance of 4 metres and differences will be compared over a timeframe of up to 12 months | 12 months |
| Central retinal thickness (CRT) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients with neovascular AMD, which are suboptimal responders to the current standard of care
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Oliver Findl, Prof. Dr. | Vienna Institute for Research in Ocular Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna Institute for Research in Ocular Surgery | Vienna | 1140 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42154394 | Derived | Spartalis C, Ullrich M, Winkler S, Leisser C, Ruiss M, Pilwachs C, Findl O. Prospective Real-World Outcomes After Switching to Aflibercept 8 mg in Neovascular Age-Related Macular Degeneration with High Treatment Burden. Ophthalmol Ther. 2026 May 19. doi: 10.1007/s40123-026-01394-1. Online ahead of print. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C533178 | aflibercept |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
CRT will be assessed using optical coherence tomography (OCT) and will be compared up to 12 months
| 12 months |
| Intraretinal fluid (IRF) | IRF will be assessed using optical coherence tomography (OCT) and compared during a timeframe up to 12 months | 12 months |