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SNCTP000003415 | NCT04101721 | BASEC2019-00937

Aflibercept bei Frühgeborenen-Retinopathie – intravitreale Injektion versus Lasertherapie Offene, randomisierte, zweiarmige, kontrollierte Studie um die Wirksamkeit, Sicherheit und Verträglichkeit des Medikaments Aflibercept (intravitreale (IVT) Injektion) im Vergleich zur Laserkoagulationsbehandlung bei Frühgeborenen mit Retinopathie (ROP) zu beurteilen

Data source: BASEC (Imported from 28.03.2024), WHO (Imported from 29.03.2024)
Changed: Nov 18, 2020, 8:54 AM
Disease category: Eye diseases

Brief description of trial (Data source: BASEC)

Frühgeborene mit Retinopathie werden nach Einwilligung in die Studie genau auf deren Eignung für die Studie überprüft. Falls geeignet, werden die Patienten zufällig entweder der Therapie mit Aflibercept (für Erwachsene in der Schweiz als Eylea zugelassen), oder mit einer Lasertherapie behandelt. Untersucht wird die Wirksamkeit, Sicherheit und Verträglichkeit von Aflibercept im Vergleich zu Lasertherapie. Diesie Hauptstudie dauert 24 Wochen. Danach gibt es eine non-interventionelle Folgestudie bis die Kinder 5 Jahre alt sind, die separat eingereicht wird.

Health conditions investigated(Data source: BASEC)

Frühgeborenen-Retinopathie Englisch: Retinopathy of preterm, abgekürzt "ROP"

Health conditions (Data source: WHO)

Retinopathy of Prematurity

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Behandlung mit dem zugelassenen Aflibercept Medikament (Eylea) im Vergleich zu Lasertherapie

Interventions (Data source: WHO)

Drug: aflibercept
Procedure: laser photocoagulation

Criteria for participation in trial (Data source: BASEC)

-Frühgeborene Patienten (früher als in der 32-ten Woche oder Geburtsgewicht unter 1500g, aber über 800g)
-Unbehandelte Retinopathie
-Einverständnis midestens von einem Elternteil oder autorisiertem Stellvertreter

Exclusion criteria (Data source: BASEC)

-bekannte Chromosomenabnormität oder bekannter Gendefekt
-Vorherige Behandlung mit Lasertherapie oder einem Behandlung des Kindes oder der Mutter während der Schwangerschaft mit einem Hemmer des vaskulären Wachstumsfaktors (anti-VEGF Behandlung)
-klinische relevante neurologische Erkrankung des Kindes, einschliesslich erhöhtem Druck im Schädel
-medizinischer Zustand des Kindes gemäss der Einschätzung der Pädiater oder des Augenarztes schliesst eine Studienteilnahme des Kindes aus

Inclusion/Exclusion Criteria (Data source: WHO)

Key Inclusion Criteria: - Gestational age at birth =32 weeks or birth weight =1500 g - Patients with treatment-naïve retinopathy of prematurity (ROP) classified according to the International Classification for ROP in at least one eye as: - Zone I Stage 1 plus, or 2 plus, or 3 non-plus or 3 plus, or - Zone II Stage 2 plus or 3 plus, or - Aggressive posterior retinopathy of prematurity (AP-ROP) Key Exclusion Criteria: - Known or suspected chromosomal abnormality, genetic disorder, or syndrome - Previous exposure to any Intravitreal (IVT) or systemic anti-vascular endothelial growth factor (VEGF) agent, including maternal exposure during pregnancy and/or during breastfeeding - Clinically significant neurological disease (eg, intraventricular hemorrhage grade 3 or higher, periventricular leukomalacia, congenital brain lesions significantly impairing optic nerve function, severe hydrocephalus with significantly increased intracranial pressure) - Pediatric conditions rendering the infant ineligible for study intervention at baseline or for repeated blood draws as evaluated by a neonatal intensive care unit specialist and a study ophthalmologist - Presence of active ocular infection within 5 days of the first treatment - Advanced stages of ROP with partial or complete retinal detachment (ROP stage 4 and stage 5) - ROP involving only Zone III NOTE: Other protocol defined inclusion/exclusion criteria apply.
Minimum age: N/A
Maximum age: N/A
Sex: All

Further information on the trial in WHO primary registry

http://www.who.int/trialsearch/Trial2.aspx?TrialID=NCT04101721

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04101721
Further information on trial

Date trial registered

Sep 23, 2019

Incorporation of the first participant

Oct 30, 2019

Recruitment status

Recruiting

Academic title (Data source: WHO)

Randomized, Controlled, Multi-Center Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Data source: WHO)

Phase 3

Primary end point (Data source: WHO)

Proportion of patients with absence of active retinopathy of prematurity (ROP) and of unfavorable structural outcomes

Secundary end point (Data source: WHO)

Proportion of patients requiring intervention with a second treatment modality
Proportion of patients with ocular treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Proportion of patients with recurrence of ROP
Proportion of patients with systematic TEAEs and SAEs

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Bern, Luzern

Countries (Data source: WHO)

Switzerland might not appear as site of trial if it has not yet been entered as such in the WHO primary registry.
Colombia, Thailand, United States, Vietnam

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Dr. Simon Rotzler
+41444658111
clinical.operations.switzerland@bayer.com

Contact for general information (Data source: WHO)

Clinical Trial Management
Regeneron Pharmaceuticals

Contact for scientific information (Data source: WHO)

Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Ethikkommission Nordwest- und Zentralschweiz EKNZ

Date of authorisation by the ethics committee

08.08.2019

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2019-00937

Secondary ID (Data source: WHO)

2019-001764-29
VGFTe-ROP-1920
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