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NCT03552770

Single or Combined Protocols for NV-AMD

Completed Phase 4 Last updated 12 June 2018
What this trial tests

Phase 4 trial testing Bevacizumab in Age-Related Macular Degeneration in 109 participants. Completed in 29 December 2016.

Timeline
23 November 2014
Primary endpoint
24 November 2016
29 December 2016

Quick facts

Lead sponsorUniversity Hospital of Ferrara
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposehealth services research
Enrollment109
Start date23 November 2014
Primary completion24 November 2016
Estimated completion29 December 2016

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital of Ferrara

Who can join

Adults 50 to 95, any sex, with Age-Related Macular Degeneration. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of Bevacizumab

Trials testing the same drug.

Other recruiting trials for Age-Related Macular Degeneration

Currently open trials in the same condition.

Other University Hospital of Ferrara trials

Trials by the same sponsor.

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Data sources for this page

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