Observational Study to Evaluate Fluid Resolution and Effectiveness in Patients Receiving Beovu in… (NCT04543331) | Clinical Trial Compass
CompletedNot Applicable
Observational Study to Evaluate Fluid Resolution and Effectiveness in Patients Receiving Beovu in Neovascular Age-related Macular Degeneration and Visual Impairment Due to Diabetic Macular Edema
Germany572 participantsStarted 2020-11-05
Plain-language summary
This study is a prospective, non-interventional, multicenter, open-label study in nAMD and DME patients being treated with brolucizumab according to the EU SmPC.
An observational study design, without a strict, mandated visit schedule or mandated treatment regimen was chosen as the most appropriate to collect available data in a real life setting. For that reason, this NIS does not impose a therapy protocol, diagnostic/therapeutic procedure or a visit schedule. The diagnostic or monitoring procedures are only those ordinarily applied to the therapeutic strategy and to routine clinical care and will take place as per investigator's discretion. This includes e.g. visit frequency, injection frequency and types of assessments performed - only data from routine medical practice will be collected as part of the study.
Who can participate
Age range
18 Years – 99 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
. Diagnosis of nAMD or visual impairment due to DME
. Male and Female nAMD and DME patients with ≥18 years of age at index
. Decision to treat with brolucizumab at baseline visit
. Signed written informed consent
. Patients for whom a therapy with brolucizumab is medically indicated
. Intraretinal and/or subretinal fluid affecting the central subfield of the study eye at Screening
Exclusion criteria
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
1
Percentage of patients' eyes that are absent of subretinal fluid (SRF) and intra-retinal fluid (IRF)
Timeframe: Month 12
2
Mean change in visual actuity (VA) under clinic specific routine treatment schemes
Timeframe: Baseline, month 12
3
Morphological CNV-Changes under clinic specific routine treatment schemes
Timeframe: Baseline, month 12
4
Percent of patients maintained on q12w dosing after loading through Week 52
Timeframe: After loading, month 12
5
Change in interval length from last interval before switch (baseline) to last interval at end of follow-up (12 months)