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NCT04543331

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

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

OBSERVATIONAL

Enrollment

572

Start Date

2020-11-05

Completion Date

2025-11-17

Last Updated

2026-07-29

Healthy Volunteers

No

Interventions

DRUG

brolucizumab

There is no treatment allocation. Patients administered Brolucizumab by prescription that have started before inclusion of the patient into the study will be enrolled.

Locations (41)

Novartis Investigative Site

Munich, Bavaria, Germany

Novartis Investigative Site

Neuburg A.d. Donau, Bavaria, Germany

Novartis Investigative Site

Würzburg, Bavaria, Germany

Novartis Investigative Site

Würzburg, Bavaria, Germany

Novartis Investigative Site

Frankfurt am Main, Hesse, Germany

Novartis Investigative Site

Göttingen, Lower Saxony, Germany

Novartis Investigative Site

Osnabrück, Lower Saxony, Germany

Novartis Investigative Site

Rostock, Mecklenburg-Vorpommern, Germany

Novartis Investigative Site

Trier, Rhineland-Palatinate, Germany

Novartis Investigative Site

Saarbrücken, Saarland, Germany

Novartis Investigative Site

Dresden, Saxony, Germany

Novartis Investigative Site

Leipzig, Saxony, Germany

Novartis Investigative Site

Schneeberg, Saxony, Germany

Novartis Investigative Site

Halle, Saxony-Anhalt, Germany

Novartis Investigative Site

Jena, Thuringia, Germany

Novartis Investigative Site

Aschersleben, Germany

Novartis Investigative Site

Bayreuth, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Bonn, Germany

Novartis Investigative Site

Breisach, Germany

Novartis Investigative Site

Chemnitz, Germany

Novartis Investigative Site

Cologne, Germany

Novartis Investigative Site

Dresden, Germany

Novartis Investigative Site

Dresden, Germany

Novartis Investigative Site

Esslingen am Neckar, Germany

Novartis Investigative Site

Glauchau, Germany

Novartis Investigative Site

Homburg, Germany

Novartis Investigative Site

Hösbach, Germany

Novartis Investigative Site

Kiel, Germany

Novartis Investigative Site

Leipzig, Germany

Novartis Investigative Site

Magdeburg, Germany

Novartis Investigative Site

Marienberg, Germany

Novartis Investigative Site

Münster, Germany

Novartis Investigative Site

Neubrandenburg, Germany

Novartis Investigative Site

Schönebeck, Germany

Novartis Investigative Site

Stralsund, Germany

Novartis Investigative Site

Sulzbach, Germany

Novartis Investigative Site

Torgau, Germany

Novartis Investigative Site

Waren, Germany

Novartis Investigative Site

Würzburg, Germany