Observational Study to Evaluate Fluid Resolution and Effectiveness in Patients Receiving Beovu in Neovascular Age-related Macular Degeneration

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

ClinicalTrials.gov Identifier: NCT04543331

Novartis Reference Number: CRTH258ADE02

Last Update: May 11, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This study is a prospective, observational, non-interventional, multicenter, open-label, single arm study in nAMD patients being treated for nAMD with brolucizumab according to the 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.

Condition 
Neovascular Age-related Macular Degeneration (nAMD)
Phase 
Not Given
Overall status 
Recruiting
Start date 
Nov 05, 2020
Completion date 
Nov 07, 2024
Gender 
All
Age(s)
40 Years - 199 Years (Adult, Older Adult)

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.

Eligibility Criteria

Inclusion Criteria:

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
Male and Female patients with ≥40 years of age at index
Decision to treatment 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 and are not eligible for treatment with brolucizumab as according to the SmPC
Patients treated for RVO, DME, mCNV, or have diagnoses of diabetes-related macular degeneration within 6 months prior to the index date
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 in the study eye at Screening
Any active intraocular or periocular infection or active intraocular inflammation in either eye at index date
Patients who have been on anti-VEGF treatment for longer than 3 years (before index date)
Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the 24 months study participation
Patients participating in parallel in an interventional clinical trial
Patients participating in parallel in any other NIS generating primary data for an anti-VEGF drug

Study Locations

Germany
Novartis Investigative Site
Recruiting
Trier, 54296
RP
Germany
Novartis Investigative Site
Recruiting
Schneeberg, 08289
Sachsen
Germany
Novartis Investigative Site
Recruiting
Aschersleben, 06449
-
Germany
Novartis Investigative Site
Recruiting
Augsburg, 86179
-
Germany
Novartis Investigative Site
Recruiting
Bayreuth, 95445
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 10713
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 14163
-
Germany
Novartis Investigative Site
Recruiting
Bonn, 53105
-
Germany
Novartis Investigative Site
Recruiting
Breisach am Rhein, 79206
-
Germany
Novartis Investigative Site
Recruiting
Chemnitz, 09113
-
Germany
Novartis Investigative Site
Recruiting
Dresden, 01067
-
Germany
Novartis Investigative Site
Recruiting
Dresden, 01257
-
Germany
Novartis Investigative Site
Recruiting
Dresden, 01307
-
Germany
Novartis Investigative Site
Recruiting
Dresden, 01324
-
Germany
Novartis Investigative Site
Recruiting
Duesseldorf, 40212
-
Germany
Novartis Investigative Site
Recruiting
Esslingen, 73728
-
Germany
Novartis Investigative Site
Recruiting
Glauchau, 08371
-
Germany
Novartis Investigative Site
Recruiting
Gottingen, 37075
-
Germany
Novartis Investigative Site
Recruiting
Halle, 06118
-
Germany
Novartis Investigative Site
Recruiting
Homburg, 66421
-
Germany
Novartis Investigative Site
Recruiting
Hösbach, 63768
-
Germany
Novartis Investigative Site
Recruiting
Kiel,
-
Germany
Novartis Investigative Site
Recruiting
Koeln, 50924
-
Germany
Novartis Investigative Site
Recruiting
Koeln, 51103
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04103
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04106
-
Germany
Novartis Investigative Site
Recruiting
Muenchen, 81377
-
Germany
Novartis Investigative Site
Recruiting
Muenster, 48145
-
Germany
Novartis Investigative Site
Recruiting
Neubrandenburg, 17036
-
Germany
Novartis Investigative Site
Recruiting
Neuburg, 86633
-
Germany
Novartis Investigative Site
Recruiting
Osnabrück, 49076
-
Germany
Novartis Investigative Site
Recruiting
Regensburg, 93 047
-
Germany
Novartis Investigative Site
Recruiting
Rhauderfehn, 26817
-
Germany
Novartis Investigative Site
Recruiting
Rostock, 18057
-
Germany
Novartis Investigative Site
Recruiting
Saarbruecken,
-
Germany
Novartis Investigative Site
Recruiting
Schoenebeck, 39218
-
Germany
Novartis Investigative Site
Recruiting
Stralsund, 18435
-
Germany
Novartis Investigative Site
Recruiting
Sulzbach, 66280
-
Germany
Novartis Investigative Site
Recruiting
Torgau, 04860
-
Germany
Novartis Investigative Site
Recruiting
Wuerzburg, 97080
-
Germany
Novartis Investigative Site
Recruiting
Wuerzburg,
-
Germany

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

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