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Susanne Binder, Ilse Krebs, Leopold Schmetterer, Manta Study Group; Twelve Months Results Comparing Ranibizumab or Bevacizumab Treatment in Patients with Neovascular Age-related Macular Degeneration(AMD) Multicenter Anti-VEGF Trial in Austria The Manta Study. Invest. Ophthalmol. Vis. Sci. 2013;54(15):4508. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
Report of an observer and subject masked trial comparing the visual outcome after treatment with Ranibizumab or Bevacizumab in patients with neovascular age-related macular degeneration
Non inferiority study based on the Data of MARINA, ANCHOR and FOCUS studies. 320 patients with NV AMD included and randomized to either Bevazizumab or Ranibizumab treatment. Three initial monthly injections with either 0.5mg ranibizumab(Lucentis*, Novartis) or 1.25 mg bevacizumab(Avastin *, Genentech). Retreatment if: VA loss a minimum of 5 letters, increase of central retinal thickness of more than 100µm (optical coherence tomography (OCT)), fresh intra-or sub retinal hemorrhage, new classic CNV , persistent intra retinal fluid (OCT+FA)
321 patients were randomized, 4 excluded (1 had previous anti-VEGF treatment, 3 received wrong drug), so that a total of 317 eyes were evaluated. Mean age, sex, baseline BCDVA and central retinal thickness was comparable in both groups. BCDVA after one year was equivalent between bevacizumab (highest gain 6.2 letters after 4 months and 4.9 letters after 12 months) and ranibizumab (highest gain 5.8 letters after 3 months and 4.1 letters after 12 months). The two drugs were also not different when adjusted for age and baseline BCVA. Mean number of treatments was also similar: 5.8x in the ranibizumab group and 6.1x in the bevacizumab group. Adjusted retinal thickness measurements showed also similar reductions over one year (decrease of 89.9µm for ranibizumab and 86.3µm for bevacizumab, p=0.81). Lesion size did decrease in both groups equally( p= 0.55). Serious adverse events were observed in 9.2 % in the ranibizumab group and in 11.6 % in the bevacizumab group. Also NR of death (2 resp3), cardiac disorders as well as gastrointestinal disorders were comparable. No serous ocular event (endopthalmitis, pseudoendophthalmotis ) did occur in both groups.
: Bevacizumab was equivalent to ranibizumab at all time points for one year. Neither the total number nor the number of adverse events in any subgroup was sign. different.
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