NCT07390253

Switch From 2mg Aflibercept to 8mg Aflibercept in Patients With Neovascular Age-related Macular Degeneration

Aflibercept 8mg in Patients Diagnosed With Neovascular Age-related Macular Degeneration (AMD) Who Have Been Treated With Aflibercept 2mg: the Eylea 8mg Switch Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Vienna Institute for Research in Ocular Surgery · Academic / Other
• Sex: All
• Age: 21 Years – 105 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Neovascular (Wet) Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Aflibercept	Intravitreal injection with high dose (8 mg) aflibercept

Timeline

• Start date: 2024-09-18
• Primary completion: 2026-02-01
• Completion: 2026-06-01
• First posted: 2026-02-05
• Last updated: 2026-02-17

Locations

1 site across 1 country: Austria