Regulatorische Post-Marketing-Überwachungsstudie für Brolucizumab
Regulatorische Post-Marketing-Surveillance-Studie (rPMS) für Brolucizumab (Beovu®-Injektion, Beovu®-Fertigspritze)
This study is an open-label, multicenter, single-arm, observational post-marketing surveillance.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Busan, Südkorea, 49201
- Novartis Investigative Site
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Busan, Südkorea, 49241
- Novartis Investigative Site
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Busan, Südkorea, 48265
- Novartis Investigative Site
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Daegu, Südkorea, 42415
- Novartis Investigative Site
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Daegu, Südkorea, 42472
- Novartis Investigative Site
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Gwangju, Südkorea, 61469
- Novartis Investigative Site
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Gwangju, Südkorea, 61932
- Novartis Investigative Site
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Gyeonggi-do, Südkorea, 11765
- Novartis Investigative Site
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Incheon, Südkorea, 22332
- Novartis Investigative Site
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Jeju City, Südkorea, 63206
- Novartis Investigative Site
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Pusan, Südkorea, 47392
- Novartis Investigative Site
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Seoul, Südkorea, 03722
- Novartis Investigative Site
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Seoul, Südkorea, 04763
- Novartis Investigative Site
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Seoul, Südkorea, 07441
- Novartis Investigative Site
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Seoul, Südkorea, 01000
- Novartis Investigative Site
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Seoul, Südkorea, 06273
- Novartis Investigative Site
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Seoul, Südkorea, 05278
- Novartis Investigative Site
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Seoul, Südkorea, 04401
- Novartis Investigative Site
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Seoul, Südkorea, 05355
- Novartis Investigative Site
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Seoul, Südkorea, 05368
- Novartis Investigative Site
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Seoul, Südkorea, 06023
- Novartis Investigative Site
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Seoul, Südkorea, 07071
- Novartis Investigative Site
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Seoul, Südkorea, 07301
- Novartis Investigative Site
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Taegu, Südkorea, 41944
- Novartis Investigative Site
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Ulsan, Südkorea, 44033
- Novartis Investigative Site
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Busan
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Busan, Busan, Südkorea, 48064
- Novartis Investigative Site
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Chungcheongnam-do
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Cheonan Si, Chungcheongnam-do, Südkorea, 31116
- Novartis Investigative Site
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Cheonan Si, Chungcheongnam-do, Südkorea, 31151
- Novartis Investigative Site
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Daegu Jung Gu
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Daegu, Daegu Jung Gu, Südkorea, 41940
- Novartis Investigative Site
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Dalseo gu
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Daegu, Dalseo gu, Südkorea, 42602
- Novartis Investigative Site
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Gwangju
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Gwangju, Gwangju, Südkorea, 61489
- Novartis Investigative Site
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Gyeonggi-do
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Anyang-si, Gyeonggi-do, Südkorea, 14068
- Novartis Investigative Site
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Goyang-si, Gyeonggi-do, Südkorea, 10380
- Novartis Investigative Site
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Guri-si, Gyeonggi-do, Südkorea, 11923
- Novartis Investigative Site
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Suwon, Gyeonggi-do, Südkorea, 16499
- Novartis Investigative Site
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Gyeongsangnam-do
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Jinju, Gyeongsangnam-do, Südkorea, 52727
- Novartis Investigative Site
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Yangsan, Gyeongsangnam-do, Südkorea, 50612
- Novartis Investigative Site
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Jeonlabuk Do
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Iksan Si, Jeonlabuk Do, Südkorea, 54538
- Novartis Investigative Site
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Korea
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Daejeon, Korea, Südkorea, 35015
- Novartis Investigative Site
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Seoul, Korea, Südkorea, 03312
- Novartis Investigative Site
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Seoul, Korea, Südkorea, 02841
- Novartis Investigative Site
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Seoul
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Seoul, Seoul, Südkorea, 06351
- Novartis Investigative Site
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Seoul, Seoul, Südkorea, 03080
- Novartis Investigative Site
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Seoul, Seoul, Südkorea, 05030
- Novartis Investigative Site
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South Korea
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Busan, South Korea, Südkorea, 47524
- Novartis Investigative Site
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
Inclusion Criteria:
- Patients aged ≥18 years with nAMD that are prescribed with Brolucizumab as per approved local product information
- 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:
- 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.
- Patients participating in other investigational drug trial
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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Brolucizumab
Patients prescribed with brolucizumab in the approved indication |
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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Incidence of adverse events at 12 weeks
Zeitfenster: 12 weeks
|
Incidence of adverse events and serious adverse events |
12 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Incidence of adverse events at 24 weeks and optionally at 36 weeks
Zeitfenster: Up to 36 weeks
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Incidence of adverse events and serious adverse events |
Up to 36 weeks
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Proportion of patients gaining or losing more than 15 letters on the ETDRS chart
Zeitfenster: 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
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Mean change of Central Subfield Thickness (CST) from baseline
Zeitfenster: Baseline, week 12, week 24, optionally week 36
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CST is measured as one parameter by Optical coherence tomography. |
Baseline, week 12, week 24, optionally week 36
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Mean change of Best Corrected Visual Acuity (BCVA) from baseline
Zeitfenster: Baseline, week 12, week 24, optionally week 36
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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
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Mean Best Corrected Visual Acuity (BCVA)
Zeitfenster: Baseline, week 12, week 24, optionally week 36
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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
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Mean Central Subfield Thickness (CST)
Zeitfenster: Baseline, Week 12, week 24, optionally week 36
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CST is measured as one parameter by Optical coherence tomography. |
Baseline, Week 12, week 24, optionally week 36
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Number of injections
Zeitfenster: Up to 36 weeks
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Number of Brolucizumab injections to be collected |
Up to 36 weeks
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Percentage of patients completing the loading phase
Zeitfenster: 4 months
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Loading phase: ≥ 3 injection during first 4 months |
4 months
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Percentage of patients who maintained with 12 weeks interval
Zeitfenster: Up to 36 weeks
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Percentage(%) of patients who maintained with 12 weeks interval |
Up to 36 weeks
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Proportion of patients with retinal fluid
Zeitfenster: Week 12, week 24, optionally week 36
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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
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Prior anti-VEGF treatment history - number of prior injections
Zeitfenster: Baseline
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Number of injections of prior anti- vascular endothelial growth factor (VEGF) treatment |
Baseline
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Prior anti-VEGF treatment history - agent of prior injections
Zeitfenster: Baseline
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Agent of prior anti - vascular endothelial growth factor (VEGF) injections |
Baseline
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Predictive factors of treatment outcomes (persistent disease activity)
Zeitfenster: Week 24
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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
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Treatment naïve/non-naïve
Zeitfenster: Baseline
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Number of participants that are treatment naïve / non-naïve to be collected |
Baseline
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Treatment interval
Zeitfenster: Up to week 36
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Number of participants by treatment interval to be collected |
Up to week 36
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Concomitant treatments
Zeitfenster: Baseline
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Number of participants with concomitant treatments to be collected |
Baseline
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Number of participants with post injection empirical treatment
Zeitfenster: Week 12, week 24, optionally week 36
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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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CRTH258AKR01
Plan für individuelle Teilnehmerdaten (IPD)
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