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

February 12, 2026 updated by: Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1140
        • Vienna Institute for Research in Ocular Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with neovascular AMD, which are suboptimal responders to the current standard of care

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
neovascular age-related macular degeneration (nAMD)
Patient suffering from neovascular age-related macular degeneration (nAMD)
Drug: Aflibercept
Intravitreal injection with high dose (8 mg) aflibercept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of intravitreal injections
Time Frame: 12 months
Total number of intravitreal injections will be assessed over 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
corrected distance visual acuity (CDVA)
Time Frame: 12 months
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)
Time Frame: 12 months
CRT will be assessed using optical coherence tomography (OCT) and will be compared up to 12 months
12 months
Intraretinal fluid (IRF)
Time Frame: 12 months
IRF will be assessed using optical coherence tomography (OCT) and compared during a timeframe up to 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vienna Institute for Research in Ocular Surgery

Investigators

  • Principal Investigator: Oliver Findl, Prof. Dr., Vienna Institute for Research in Ocular Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2024

Primary Completion (Actual)

February 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

January 28, 2026

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • High Dose (HD) Eylea

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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