Single or Combined Protocols for NV-AMD
8. Juni 2018 aktualisiert von: Francesco Parmeggiani, University Hospital of Ferrara
Single or Combined Protocols for the Treatment of Patients With Neovascular Age-related Macular Degeneration: Compliance, Risk/Benefit and Cost/Benefit Ratios
The present interventional study represents a Research Program for the Clinical Governance supported by supported by the Healthcare Fund of the Emilia-Romagna Region.
It aims to evaluate, after 12 months of monitoring, clinical safety, therapeutic efficacy, number of intra-vitreous injections of bevacizumab (IVIB), compliance and quality of life correlated to the vision by comparing the data obtained in two groups of patients (group A and group B), affected by neovascular age-related macular degeneration (NV-AMD) never previously treated or already undergoing pro-re-nata (PRN) treatments with biological drugs inhibiting vascular endothelial growth factor (Vascular Endothelial Growth Factor, VEGF), i.e. anti-VEGF drugs.
Participating patients are randomized to the following therapeutic regimens: i. group A, a single intra-vitreous injection of bevacizumab PRN repeated after monthly periodic monitoring of the patient (IVIBx1 regimen); ii. group B, two combined intra-vitreous injections of bevacizumab, spaced 30 ± 10 days apart and repeated as-needed after periodic monitoring of the patient (IVIBx2 regimen).
Within the aforementioned regimens, the re-treatment (single or combined in patients undergoing IVIBx1 or IVIBx2, respectively) is performed when signs of persistent neovascular activity is present.
The present trial consists of a randomized controlled open-label study with parallel arms to evaluate the non-inferiority of clinical safety and therapeutic efficacy of the IVIBx1 regimen compared to the IVIBx2 regimen (1: 1 allocation) administered in patients with NV-AMD.
The number and type of tests, as well as the number of intra-vitreous injections of anti-VEGF drug performed in patients treated with the PRN regimens IVIBx1 or IVIBx2 do not differ from those performed during normal clinical practice at the Eye Clinic of the University Hospital of Ferrara.
The intra-vitreous administration of bevacizumab is performed in accordance with the guidelines of the Italian Ophthalmology Society.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
109
Phase
- Phase 4
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
50 Jahre bis 95 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- age > 50 years
- ability to comply with study procedures
- active NV-AMD in either treatment-naïve or previously treated patients
- BCVA > 20/200 in the study eye
Exclusion Criteria:
- any other possible cause of choroidal neovascularization other than AMD
- ocular media opacities or other causes counteracting data collection
- presence or onset of contraindications to the use of bevacizumab
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: IVIBx1
Patients treated with a single intra-vitreous injection of bevacizumab (1.25 mg in 0.05 ml of solution) pro-re-nata repeated after monthly periodic monitoring of each patient
|
pro-re-nata repeated single or combined intra-vitreous injection of bevacizumab
Andere Namen:
|
|
Aktiver Komparator: IVIBx2
Patients treated with two combined intra-vitreous injections of bevacizumab, (1.25 mg in 0.05 ml of solution) spaced 30 ± 10 days apart and pro-re-nata repeated after periodic monitoring of each patient
|
pro-re-nata repeated single or combined intra-vitreous injection of bevacizumab
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
comparison of the mean modifications of the maximal visual acuity (BCVA, Best-Corrected Visual Acuity) between the IVIBx1 study group with respect to those registered in the IVIBx2 one
Zeitfenster: 12 months
|
verify the "non-inferiority" of the therapeutic efficacy of the IVIBx2 regimen versus IVIBx1 regimen, considering the mean modification of the maximal visual acuity (BCVA, Best-Corrected Visual Acuity)
|
12 months
|
|
comparison of the number of intra-vitreous injections of bevacizumab (IVIB) between the IVIBx1 study group with respect to those performed in the IVIBx2 one
Zeitfenster: 12 months
|
verify the "non-inferiority" of the therapeutic responsiveness of the IVIBx2 regimen versus IVIBx1 regimen, considering the number of intra-vitreous injections of bevacizumab (IVIB)
|
12 months
|
|
comparison of the number of non-severe adverse events (NSAE) between the IVIBx1 study group with respect to those registered in the IVIBx2 one
Zeitfenster: 12 months
|
verify the "non-inferiority" of the tolerability of the IVIBx2 regimen versus IVIBx1 regimen, considering the number of non-severe adverse events (NSAE)
|
12 months
|
|
comparison of the number of severe adverse events (SAE) between the IVIBx1 study group with respect to those registered in the IVIBx2 one
Zeitfenster: 12 months
|
verify the "non-inferiority" of the safety of the IVIBx2 regimen versus IVIBx1 regimen, considering the number of severe adverse events (SAE)
|
12 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
comparison of the number of unjustified absences of patients at the diagnostic checks and/or therapeutic procedures between the IVIBx1 study group with respect to those registered in the IVIBx2 one
Zeitfenster: 12 months
|
verify the "non-inferiority" of the objective patient's compliance during the IVIBx2 regimen versus IVIBx1 regimen, considering the number of unjustified absences of patients at the diagnostic checks and/or therapeutic procedures foreseen by the study
|
12 months
|
|
comparison of the mean modifications of the score of the National Eye Institute Visual Functioning Questionnaire (NEI-VFQ) between the IVIBx1 study group with respect to those registered in the IVIBx2 one
Zeitfenster: 12 months
|
verify the "non-inferiority" of the vision-related quality of life during the IVIBx2 regimen versus IVIBx1 regimen, considering the mean modification of the score of the National Eye Institute Visual Functioning Questionnaire (NEI-VFQ)
|
12 months
|
|
comparison of the mean modification of the score of a specific questionnaire about patient's satisfaction for the received care between the IVIBx1 study group with respect to those registered in the IVIBx2 one
Zeitfenster: 12 months
|
verify the "non-inferiority" of the subjective patient's compliance during the IVIBx2 regimen versus IVIBx1 regimen, considering the mean modification of the score of a specific questionnaire about the assessment of patient satisfaction with respect to the received healthcare
|
12 months
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
23. November 2014
Primärer Abschluss (Tatsächlich)
24. November 2016
Studienabschluss (Tatsächlich)
29. Dezember 2016
Studienanmeldedaten
Zuerst eingereicht
28. Mai 2018
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
8. Juni 2018
Zuerst gepostet (Tatsächlich)
12. Juni 2018
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
12. Juni 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
8. Juni 2018
Zuletzt verifiziert
1. Juni 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- PRUA2-2013-00002008
Plan für individuelle Teilnehmerdaten (IPD)
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NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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