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Regulatory Post-Marketing Surveillance Study for Brolucizumab

3. november 2026 opdateret af: Novartis Pharmaceuticals

Regulatory Post-Marketing Surveillance (rPMS) undersøgelse for Brolucizumab (Beovu ® Injection, Beovu ® Prefilled Syringe)

This study is an open-label, multicenter, single-arm, observational post-marketing surveillance.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The investigators will collect safety information and evaluate effectiveness in patients who are prescribed Beovu ® Injection, Beovu ®Prefilled Syringe (brolucizumab) in the approved indication after receiving informed consent over a period of 12 weeks. In addition, longer-term data (24 weeks, optionally 36 weeks) will be collected.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

3369

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Sydkorea
      • Busan, Sydkorea, 49201
        • Novartis Investigative Site
      • Busan, Sydkorea, 49241
        • Novartis Investigative Site
      • Busan, Sydkorea, 48265
        • Novartis Investigative Site
      • Daegu, Sydkorea, 42415
        • Novartis Investigative Site
      • Daegu, Sydkorea, 42472
        • Novartis Investigative Site
      • Gwangju, Sydkorea, 61469
        • Novartis Investigative Site
      • Gwangju, Sydkorea, 61932
        • Novartis Investigative Site
      • Gyeonggi-do, Sydkorea, 11765
        • Novartis Investigative Site
      • Incheon, Sydkorea, 22332
        • Novartis Investigative Site
      • Jeju City, Sydkorea, 63206
        • Novartis Investigative Site
      • Pusan, Sydkorea, 47392
        • Novartis Investigative Site
      • Seoul, Sydkorea, 03722
        • Novartis Investigative Site
      • Seoul, Sydkorea, 04763
        • Novartis Investigative Site
      • Seoul, Sydkorea, 07441
        • Novartis Investigative Site
      • Seoul, Sydkorea, 01000
        • Novartis Investigative Site
      • Seoul, Sydkorea, 06273
        • Novartis Investigative Site
      • Seoul, Sydkorea, 05278
        • Novartis Investigative Site
      • Seoul, Sydkorea, 04401
        • Novartis Investigative Site
      • Seoul, Sydkorea, 05355
        • Novartis Investigative Site
      • Seoul, Sydkorea, 05368
        • Novartis Investigative Site
      • Seoul, Sydkorea, 06023
        • Novartis Investigative Site
      • Seoul, Sydkorea, 07071
        • Novartis Investigative Site
      • Seoul, Sydkorea, 07301
        • Novartis Investigative Site
      • Taegu, Sydkorea, 41944
        • Novartis Investigative Site
      • Ulsan, Sydkorea, 44033
        • Novartis Investigative Site
    • Busan
      • Busan, Busan, Sydkorea, 48064
        • Novartis Investigative Site
    • Chungcheongnam-do
      • Cheonan Si, Chungcheongnam-do, Sydkorea, 31116
        • Novartis Investigative Site
      • Cheonan Si, Chungcheongnam-do, Sydkorea, 31151
        • Novartis Investigative Site
    • Daegu Jung Gu
      • Daegu, Daegu Jung Gu, Sydkorea, 41940
        • Novartis Investigative Site
    • Dalseo gu
      • Daegu, Dalseo gu, Sydkorea, 42602
        • Novartis Investigative Site
    • Gwangju
      • Gwangju, Gwangju, Sydkorea, 61489
        • Novartis Investigative Site
    • Gyeonggi-do
      • Anyang-si, Gyeonggi-do, Sydkorea, 14068
        • Novartis Investigative Site
      • Goyang-si, Gyeonggi-do, Sydkorea, 10380
        • Novartis Investigative Site
      • Guri-si, Gyeonggi-do, Sydkorea, 11923
        • Novartis Investigative Site
      • Suwon, Gyeonggi-do, Sydkorea, 16499
        • Novartis Investigative Site
    • Gyeongsangnam-do
      • Jinju, Gyeongsangnam-do, Sydkorea, 52727
        • Novartis Investigative Site
      • Yangsan, Gyeongsangnam-do, Sydkorea, 50612
        • Novartis Investigative Site
    • Jeonlabuk Do
      • Iksan Si, Jeonlabuk Do, Sydkorea, 54538
        • Novartis Investigative Site
    • Korea
      • Daejeon, Korea, Sydkorea, 35015
        • Novartis Investigative Site
      • Seoul, Korea, Sydkorea, 03312
        • Novartis Investigative Site
      • Seoul, Korea, Sydkorea, 02841
        • Novartis Investigative Site
    • Seoul
      • Seoul, Seoul, Sydkorea, 06351
        • Novartis Investigative Site
      • Seoul, Seoul, Sydkorea, 03080
        • Novartis Investigative Site
      • Seoul, Seoul, Sydkorea, 05030
        • Novartis Investigative Site
    • South Korea
      • Busan, South Korea, Sydkorea, 47524
        • Novartis Investigative Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 100 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients aged ≥18 years who present to the participating study sites, where the decision to newly prescribe Beovu ® Injection, Beovu ®Prefilled Syringe (brolucizumab) were made prior to evaluating eligibility for this study.

Beskrivelse

Inclusion Criteria:

  1. Patients aged ≥18 years with nAMD that are prescribed with Brolucizumab as per approved local product information
  2. Patients who consent to participate in the study after the purpose and nature of the study have clearly explained to them (written informed consent)

Exclusion Criteria:

  1. Contraindications as per local prescribing information 1) Hypersensitivity to the active substance or to any of the excipients. 2) Active or suspected ocular or periocular infection. 3) Active intraocular inflammation.
  2. Patients participating in other investigational drug trial

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Brolucizumab

Patients prescribed with brolucizumab in the approved indication
Andet: brolucizumab

Prospective observational study. There is no treatment allocation. Patients administered brolucizumab, that have started before inclusion of the patient into the study will be enrolled.

Andre navne:
  • Beovu

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of adverse events at 12 weeks
Tidsramme: 12 weeks

Incidence of adverse events and serious adverse events
12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of adverse events at 24 weeks and optionally at 36 weeks
Tidsramme: Up to 36 weeks

Incidence of adverse events and serious adverse events
Up to 36 weeks
Proportion of patients gaining or losing more than 15 letters on the ETDRS chart
Tidsramme: Week 12, week 24, optionally week 36

The ETDRS chart has been introduced as a standardized visual acuity (VA) testing chart. It uses 14 lines of 5 Sloan letter optotypes in each line in logarithmic progression. The space between lines and letters is proportionally equal keeping the effect of contour interaction constant. The threshold VA corresponds to the line in which 3 out of 5 optotypes were correctly identified. Alternatively, a by-letter scoring system (-0.02 logMAR credited for each letter correctly read) can be used. The testing distance can be varied; the corresponding visual acuity can be read easily from the chart. The chart is mounted on a box that is backlit by fluorescent tubes. For repeated measurements, the chart itself can be exchanged, providing different letters for different eyes.
Week 12, week 24, optionally week 36
Mean change of Central Subfield Thickness (CST) from baseline
Tidsramme: Baseline, week 12, week 24, optionally week 36

CST is measured as one parameter by Optical coherence tomography.
Baseline, week 12, week 24, optionally week 36
Mean change of Best Corrected Visual Acuity (BCVA) from baseline
Tidsramme: Baseline, week 12, week 24, optionally week 36

BCVA is the best possible vision that an eye can achieve with the use of glasses or contact lenses. It is measured by ETDRS chart or equivalent with the use of glasses or contact lenses
Baseline, week 12, week 24, optionally week 36
Mean Best Corrected Visual Acuity (BCVA)
Tidsramme: Baseline, week 12, week 24, optionally week 36

BCVA is the best possible vision that an eye can achieve with the use of glasses or contact lenses. It is measured by ETDRS chart or equivalent with the use of glasses or contact lenses
Baseline, week 12, week 24, optionally week 36
Mean Central Subfield Thickness (CST)
Tidsramme: Baseline, Week 12, week 24, optionally week 36

CST is measured as one parameter by Optical coherence tomography.
Baseline, Week 12, week 24, optionally week 36
Number of injections
Tidsramme: Up to 36 weeks

Number of Brolucizumab injections to be collected
Up to 36 weeks
Percentage of patients completing the loading phase
Tidsramme: 4 months

Loading phase: ≥ 3 injection during first 4 months
4 months
Percentage of patients who maintained with 12 weeks interval
Tidsramme: Up to 36 weeks

Percentage(%) of patients who maintained with 12 weeks interval
Up to 36 weeks
Proportion of patients with retinal fluid
Tidsramme: Week 12, week 24, optionally week 36

Proportion of patients with Intraretinal fluid (IRF), subretinal fluid (SRF) or sub-retinal pigment epithelium (sub-RPE) fluid defined as presence/absence
Week 12, week 24, optionally week 36
Prior anti-VEGF treatment history - number of prior injections
Tidsramme: Baseline

Number of injections of prior anti- vascular endothelial growth factor (VEGF) treatment
Baseline
Prior anti-VEGF treatment history - agent of prior injections
Tidsramme: Baseline

Agent of prior anti - vascular endothelial growth factor (VEGF) injections
Baseline
Predictive factors of treatment outcomes (persistent disease activity)
Tidsramme: Week 24

Predictive factors of patients identified with persistent disease activity. Persistent disease activity is defined as presence of fluid and CST of at least 200µm
Week 24
Treatment naïve/non-naïve
Tidsramme: Baseline

Number of participants that are treatment naïve / non-naïve to be collected
Baseline
Treatment interval
Tidsramme: Up to week 36

Number of participants by treatment interval to be collected
Up to week 36
Concomitant treatments
Tidsramme: Baseline

Number of participants with concomitant treatments to be collected
Baseline
Number of participants with post injection empirical treatment
Tidsramme: Week 12, week 24, optionally week 36

Post injection emperical treatment means any medication or therapy (usually topical medication such as topical antibiotics, topical steroid..etc.) routinely prescribed on the same day of injection in order to prevent post injection complications. It is differentiated from concomitant medication.
Week 12, week 24, optionally week 36

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Pharmaceuticals

Efterforskere

  • Studieleder: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. august 2021

Primær færdiggørelse (Faktiske)

14. juni 2026

Studieafslutning (Faktiske)

14. juni 2026

Datoer for studieregistrering

Først indsendt

22. juli 2021

Først indsendt, der opfyldte QC-kriterier

22. juli 2021

Først opslået (Faktiske)

2. august 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CRTH258AKR01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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