Single or Combined Protocols for NV-AMD
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional
Phase: Phase 4

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.
    


Intervention name(s): Bevacizumab
Intervention type(s): Drug
Intervention description(s): pro-re-nata repeated single or combined intra-vitreous injection of bevacizumab
Other intervention name(s): intra-vitreous injection of bevacizumab
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
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).
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: neovascular age-related macular degeneration; bevacizumab; pro-re-nata regimens; clinical governance