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Regulatory Post-Marketing Surveillance Study för Brolucizumab

3 november 2026 uppdaterad av: Novartis Pharmaceuticals

Regulatory Post-Marketing Surveillance (rPMS)-studie för Brolucizumab (Beovu ® Injection, Beovu ® Prefilled Syringe)

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

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

3369

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 100 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiv: PROSPECTIVE

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Brolucizumab

Patients prescribed with brolucizumab in the approved indication
Övrig: 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.

Andra namn:
  • Beovu

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence of adverse events at 12 weeks
Tidsram: 12 weeks

Incidence of adverse events and serious adverse events
12 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence of adverse events at 24 weeks and optionally at 36 weeks
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: Up to 36 weeks

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

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

Percentage(%) of patients who maintained with 12 weeks interval
Up to 36 weeks
Proportion of patients with retinal fluid
Tidsram: 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
Tidsram: Baseline

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

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

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

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

Number of participants with concomitant treatments to be collected
Baseline
Number of participants with post injection empirical treatment
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Novartis Pharmaceuticals

Utredare

  • Studierektor: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

18 augusti 2021

Primärt slutförande (Faktisk)

14 juni 2026

Avslutad studie (Faktisk)

14 juni 2026

Studieregistreringsdatum

Först inskickad

22 juli 2021

Först inskickad som uppfyllde QC-kriterierna

22 juli 2021

Första postat (Faktisk)

2 augusti 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CRTH258AKR01

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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