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NCT04543331Completed

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

OBservationaL stUdy to Evaluate Fluid reSolution and Effectiveness in Patients Receiving Beovu (Brolucizumab) Under KeY Treatment Schemes in Neovascular Age-related Macular Degeneration and Visual Impairment Due to Diabetic Macular Edema

Source: ClinicalTrials.gov · Last updated 29 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
572 (actual)
First submitted
4 Sept 2020
Start date
5 Nov 2020
Primary completion date
17 Nov 2025
Lead sponsor
Novartis Pharmaceuticals
NCT number
NCT04543331

What you commit to

  • Study type: Observational
  • Participants enrolled: 572
  • From 5 Nov 2020 to the primary completion date, 17 Nov 2025
  • 35 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients that have any contraindication or are not eligible for treatment with brolucizumab as according to the SmPC
  • Patients participating in parallel in any other NIS generating primary data for an anti-VEGF drug
  • Laser photocoagulation (focal/grid or panretinal) in the study eye during the 3-month period prior to baseline
  • Prior use of intraocular or periocular corticosteroids in the study eye provided at least 4 months prior to baseline

Other illness

  • Any active intraocular or periocular infection or active intraocular inflammation in either eye at index date
  • Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the 24 months study participation

Other

  • 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)
  • Patients who have been on anti-VEGF treatment for longer than 3 years (before index date)
  • Patients participating in parallel in an interventional clinical trial
  • Pregnancy and breast-feeding

Who the study is looking for

  • The unit of analysis is patient-eye, i.e. all criteria should be applied to the study eye, unless otherwise specified. Patients will be included in the study if they fulfil the following requisites:
  • 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

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (35)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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AscherslebenGermanyUnknown status
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BayreuthGermanyUnknown status
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BerlinGermanyUnknown status
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BonnGermanyUnknown status
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BreisachGermanyUnknown status
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ChemnitzGermanyUnknown status
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CologneGermanyUnknown status
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DresdenGermanyUnknown status
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Esslingen am NeckarGermanyUnknown status
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Frankfurt am MainGermanyUnknown status
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GlauchauGermanyUnknown status
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GöttingenGermanyUnknown status
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HalleGermanyUnknown status
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HomburgGermanyUnknown status
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HösbachGermanyUnknown status
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JenaGermanyUnknown status
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KielGermanyUnknown status
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LeipzigGermanyUnknown status
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MagdeburgGermanyUnknown status
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MarienbergGermanyUnknown status
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MunichGermanyUnknown status
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MünsterGermanyUnknown status
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NeubrandenburgGermanyUnknown status
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Neuburg A.d. DonauGermanyUnknown status
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OsnabrückGermanyUnknown status
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RostockGermanyUnknown status
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SaarbrückenGermanyUnknown status
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SchneebergGermanyUnknown status
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SchönebeckGermanyUnknown status
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StralsundGermanyUnknown status
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SulzbachGermanyUnknown status
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TorgauGermanyUnknown status
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TrierGermanyUnknown status
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WarenGermanyUnknown status
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WürzburgGermanyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.