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
1 other identifier
observational
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 18, 2024
CompletedFirst Submitted
Initial submission to the registry
January 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedFirst Posted
Study publicly available on registry
February 5, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedFebruary 17, 2026
February 1, 2026
1.4 years
January 28, 2026
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of intravitreal injections
Total number of intravitreal injections will be assessed over 12 months
12 months
Secondary Outcomes (3)
corrected distance visual acuity (CDVA)
12 months
Central retinal thickness (CRT)
12 months
Intraretinal fluid (IRF)
12 months
Study Arms (1)
neovascular age-related macular degeneration (nAMD)
Patient suffering from neovascular age-related macular degeneration (nAMD)
Interventions
Intravitreal injection with high dose (8 mg) aflibercept
Eligibility Criteria
Patients with neovascular AMD, which are suboptimal responders to the current standard of care
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vienna Institute for Research in Ocular Surgery
Vienna, 1140, Austria
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oliver Findl, Prof. Dr.
Vienna Institute for Research in Ocular Surgery
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 28, 2026
First Posted
February 5, 2026
Study Start
September 18, 2024
Primary Completion
February 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
February 17, 2026
Record last verified: 2026-02