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

NCT04543331 | Completed

• 1 other identifier: CRTH258ADE02
• Study Type: observational
• Target: 572
• Locations: 1 country
• Sites: 41

Brief 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.

Conditions

Neovascular Age-related Macular Degeneration (nAMD); Diabetic Macular Edema (DME)

Keywords

Beovu; Brolucizumab; nAMD; DME; non-interventional trial; effectiveness; fluid resolution; treatment intervals; real world study

Outcome Measures

Primary Outcomes (5)

• Percentage of patients' eyes that are absent of subretinal fluid (SRF) and intra-retinal fluid (IRF)

  This outcome measure is part of the BLUE SKY AMD module. This primary study objective will be addressed considering treatment naïve and pre-treated patient eyes, analyzed as two independent groups (naïve and switch).

  Month 12

• Mean change in visual actuity (VA) under clinic specific routine treatment schemes

  This outcome measure is part of the BIRL module. This primary study objective will be addressed considering treatment naïve patient eyes. Index date (Baseline): defined as the date of the first anti-VEGF injection (brolucizumab) in patient eye.

  Baseline, month 12

• Morphological CNV-Changes under clinic specific routine treatment schemes

  This outcome measure is part of the BIRL module. This primary study objective will be addressed considering treatment naïve patient eyes. Index date (Baseline): defined as the date of the first anti-VEGF injection (brolucizumab) in patient eye.

  Baseline, month 12

• Percent of patients maintained on q12w dosing after loading through Week 52

  This outcome measure is part of the BLUE SKY DME module. This primary study objective will be addressed considering treatment naïve patient eyes included in the study.

  After loading, month 12

• Change in interval length from last interval before switch (baseline) to last interval at end of follow-up (12 months)

  This outcome measure is part of the BLUE SKY DME module. This primary study objective will be addressed considering pre-treated patient eyes. Index date (Baseline): defined as the date of the first anti-VEGF injection (brolucizumab) in patient eyes.

  Baseline, month 12

Secondary Outcomes (21)

• Characterize nAMD patients who initiated treatment with brolucizumab with the respect to baseline characteristics

  Baseline

• Evaluate anatomical parameters during treatment with brolucizumab

  Up to month 24

• Evaluate VA change from baseline during treatment with brolucizumab

  Baseline, month 24

• Estimate number of anti-VEGF injections, visits and injection intervals

  Up to month 24

• Estimate percentage of switchers during first 6 months and characterize switchers

  Baseline, month 6

Study Arms (2)

treatment naïve patients

Patients being the first time treated for nAMD or DME

Drug: brolucizumab

pre-treated patients

Patients already being treated for nAMD or DME

Drug: brolucizumab

Interventions

brolucizumab DRUG

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

pre-treated patients; treatment naïve patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients being treated for nAMD or DME with brolucizumab will be enrolled in the study upon signing an informed consent.

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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
• 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
• Pregnancy and breast-feeding

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (41)

Novartis Investigative Site

Munich, Bavaria, 81377, Germany

Location

Novartis Investigative Site

Würzburg, Bavaria, 97070, Germany

Location

Novartis Investigative Site

Würzburg, Bavaria, 97080, Germany

Location

Novartis Investigative Site

Frankfurt am Main, Hesse, 60590, Germany

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Novartis Investigative Site

Göttingen, Lower Saxony, 37075, Germany

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Novartis Investigative Site

Osnabrück, Lower Saxony, 49076, Germany

Location

Novartis Investigative Site

Rostock, Mecklenburg-Vorpommern, 18057, Germany

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Novartis Investigative Site

Trier, Rhineland-Palatinate, 54296, Germany

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Novartis Investigative Site

Dresden, Saxony, 01307, Germany

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Novartis Investigative Site

Leipzig, Saxony, 04103, Germany

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Novartis Investigative Site

Schneeberg, Saxony, 08289, Germany

Location

Novartis Investigative Site

Halle, Saxony-Anhalt, 06118, Germany

Location

Novartis Investigative Site

Jena, Thuringia, 07740, Germany

Location

Novartis Investigative Site

Aschersleben, 06449, Germany

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Novartis Investigative Site

Bayreuth, 95445, Germany

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Novartis Investigative Site

Berlin, 10713, Germany

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Novartis Investigative Site

Berlin, 14163, Germany

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Novartis Investigative Site

Bonn, 53105, Germany

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Novartis Investigative Site

Breisach, 79206, Germany

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Novartis Investigative Site

Chemnitz, 09113, Germany

Location

Novartis Investigative Site

Cologne, 50968, Germany

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Novartis Investigative Site

Dresden, 01067, Germany

Location

Novartis Investigative Site

Dresden, 01324, Germany

Location

Novartis Investigative Site

Esslingen am Neckar, 73728, Germany

Location

Novartis Investigative Site

Glauchau, 08371, Germany

Location

Novartis Investigative Site

Homburg, 66421, Germany

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Novartis Investigative Site

Hösbach, 63768, Germany

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Novartis Investigative Site

Kiel, 24103, Germany

Location

Novartis Investigative Site

Leipzig, 04106, Germany

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Novartis Investigative Site

Magdeburg, 39104, Germany

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Novartis Investigative Site

Marienberg, 09496, Germany

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Novartis Investigative Site

Münster, 48145, Germany

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Novartis Investigative Site

Neubrandenburg, 17036, Germany

Location

Novartis Investigative Site

Neuburg am Inn, 86633, Germany

Location

Novartis Investigative Site

Saarbrücken, 66111, Germany

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Novartis Investigative Site

Schönebeck, 39218, Germany

Location

Novartis Investigative Site

Stralsund, 18435, Germany

Location

Novartis Investigative Site

Sulzbach, 66280, Germany

Location

Novartis Investigative Site

Torgau, 04860, Germany

Location

Novartis Investigative Site

Waren, 17192, Germany

Location

Novartis Investigative Site

Würzburg, 97080, Germany

Location

MeSH Terms

Interventions

brolucizumab

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 10, 2020
• Study Start: November 5, 2020
• Primary Completion: November 17, 2025
• Study Completion: November 17, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (41)