Single or Combined Protocols for NV-AMD

NCT ID: NCT03552770

Last Updated: 2018-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-23
• Study Completion Date: 2016-12-29

Brief Summary

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.

Conditions

Age-Related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Bevacizumab

Intervention Type: DRUG

pro-re-nata repeated single or combined intra-vitreous injection of bevacizumab

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

Group Type: ACTIVE_COMPARATOR

Bevacizumab

Intervention Type: DRUG

pro-re-nata repeated single or combined intra-vitreous injection of bevacizumab

Interventions

Bevacizumab

pro-re-nata repeated single or combined intra-vitreous injection of bevacizumab

Intervention Type: DRUG

Other Intervention Names

intra-vitreous injection of bevacizumab

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regione Emilia-Romagna

OTHER

Sponsor Role: collaborator

University Hospital of Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Francesco Parmeggiani

Medical Doctor - Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PRUA2-2013-00002008

Identifier Type: -

Identifier Source: org_study_id