Active — Not RecruitingNot Applicable

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

Austria50 participantsStarted 2024-09-18

Plain-language 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.

Who can participate

Age range

21 Years – 105 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of intravitreal injections

Timeframe: 12 months

Trial details

NCT IDNCT07390253

SponsorVienna Institute for Research in Ocular Surgery

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-02-01

View on ClinicalTrials.gov More Neovascular (Wet) Age-Related Macular Degeneration trials

Who can participate

Age range

21 Years – 105 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.