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 range18 Years – 99 Years
SexALL
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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
✕. Patients that have any contraindication or are not eligible for treatment with brolucizumab as according to the SmPC
✕. Patients treated for RVO or CNV other than nAMD
✕. Receipt of any anti-VEGF treatment other than brolucizumab in the study eye at index date
✕. Central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis \>50% of the total lesion (nAMD)
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)