Clinical trial NCT03552770: Single or Combined Protocols for NV-AMD
Official title: Single or Combined Protocols for the Treatment of Patients With Neovascular Age-related Macular Degeneration: Compliance, Risk/Benefit and Cost/Benefit Ratios
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Age-Related Macular Degeneration
Keywords: neovascular age-related macular degeneration
bevacizumab
pro-re-nata regimens
clinical governance
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
Collaborators: name: Regione Emilia-Romagna
First posted: 2018-06-12
Enrollment: 109
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The enrolled patients are randomized to the following therapeutic regimens: i. group A, a single intra-vitreous injection of bevacizumab pro-re-nata 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 pro-re-nata repeated after periodic monitoring of the patient (IVIBx2 regimen).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: comparison of the number of non-severe adverse events (NSAE) between the IVIBx1 study group with respect to those registered in the IVIBx2 one
timeFrame: 12 months
measure: comparison of the number of severe adverse events (SAE) between the IVIBx1 study group with respect to those registered in the IVIBx2 one
timeFrame: 12 months
Secondary outcomes:
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 12 months
Other outcomes:
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