The Eylea 8mg Switch Study

Vienna Institute for Research in Ocular Surgery

Status: Active, not recruiting

Conditions: Neovascular (Wet) Age-Related Macular Degeneration

Treatments: Drug: Aflibercept

Study type: Observational

Funder types: Other

Identifiers

NCT07390253

HD Eylea

Details and patient eligibility

About

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.

Full description

Aflibercept 8 mg was recently approved by the 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, 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 21 to 105 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients, who received prior intravitreal anti-VEGF-treatment for nAMD with Aflibercept 2mg. A minimum of four injections of Aflibercept 2mg is required. Therefore 16-24 weeks prior treatment with anti-VEGF is required in line with an interval of 4-8 weeks.
• Short treatment intervals of 4 or 8 weeks
• nAMD
• Age 21 or older
• Written informed consent

Exclusion criteria

• Chronic treatment with Bevacizumab or Faricimab
• Extensive macular fibrosis
• Diabetic retinopathy
• Other retinal pathologies (e.g. retinal vein occlusion)
• Dense media opacities (cataract, corneal scars)
• Vitreous hemorrhage
• Ocular or periocular infections
• Active intraocular inflammation
• Hypersensitivity to the active substance or to any of the excipients
• Prior Aflibercept 8mg treatment
• Pregnancy (for women in reproductive age a pregnancy test will be performed)

Trial design

50 participants in 1 patient group

nAMD

Description:

Patient suffering from nAMD

Treatment:

Drug: Aflibercept