Comparison of Rapid Aflibercept and Brolucizumab T&E in wAMD (NCT04932980) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Comparison of Rapid Aflibercept and Brolucizumab T&E in wAMD
Switzerland80 participantsStarted 2022-05-09
Plain-language summary
The currently widely established and preferred protocol for the treatment of wet age-related macular degeneration includes a loading phase of three monthly injections without interim adaptation or treatment according to disease activity, thereafter following a T\&E strategy with treatment adaptation in increments of 2-4 weeks according to disease activity. Based on pharmacological considerations regarding the vitreal half-life of the drugs, the aim of this prospective explorative study is to test whether an early extension of treatment intervals without a loading phase is an option without compromising functional outcomes. Based on a superiority of Afl compared to Ran with regard to achieving a dry retina after one year and based on studies, but in the absence of real-life experience with Bro, it seems of interest to test how far Afl and Bro are comparable in terms of their potential to extend the treatment intervals over 12 months, the time to dryness of the retina, and number of injections. Also, it is of high clinical relevance to demonstrate efficacy with longer initial treatment intervals compared to the current possibly over-treating loading-phase with three four-weekly injections.
Who can participate
Age range
50 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:
* Active MNV secondary to nAMD, going along with clinically significant vision loss
* Patients aged 50 years or older of all sexes
* Presence of IRF and/or SRF and/or subretinal hyperreflective material affecting the central subfield of the study eye on OCT
* signed informed consent for this study prior to the screening visit
* If possible: availability of a smartphone and willingness to perform self-testing with the Alleye app (soft criteria)
Exclusion Criteria:
* Any other cause of macular oedema
* Structural damage to the macula precluding a visual potential
* Optical media opacities not allowing an accurate performance of the protocol examinations
* Any intraocular surgery within three months prior to inclusion and history of any vitreoretinal surgery
* Advanced diabetic retinopathy potentially requiring any treatment within six months following inclusion or history of vitreal haemorrhage
* Presence of vitreoretinal traction or tractive epiretinal membrane affecting the fovea
* History of IVT with anti-VEGF or corticosteroids at any time in the study eye
* Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc.
* Significantly worse functional prognosis in the other eye or only eye
* Women of childbearing potential not willing to use an effective method of contraception during treatment and until at least 3 months after the last treatment
* Pregnant or lactating women
* Any systemic au…
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.