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Christina Frennesson, Sven Erik Nilsson; A Three-year Follow-up of Ranibizumab Treatment of Neovascular AMD: Impact on Visual Outcome of Carrying Forward the Last Acuity Observation in Drop-outs. Invest. Ophthalmol. Vis. Sci. 2013;54(15):3820.
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To analyse a three-year clinical patient cohort of ranibizumab treatment of exudative age-related macular degeneration (AMD), to investigate the impact on visual outcome of carrying forward the last acuity observation in drop-outs and to explore possible differences between the early and the late phase of the study.
A retrospective study of 312 eyes with neovascular AMD. The patients were followed up monthly, received three initial monthly injections of 0.5 mg ranibizumab and were re-treated pro re nata (PRN). Sixty-five patients were discontinued from the study. Primary outcome: change in best corrected visual acuity (BCVA).
BCVA was 58.4 ETDRS letters. At three months, it had increased by 4.1 letters (p=0.0004), at 12 months by 1.8 letters, at 24 months by 1.0 letter and at 36 months by 0.1 letter. However, if the last available acuity of drop-outs was carried forward one step and included, acuity had increased by 3.9 letters at 3 months (p<0.0001) and by 1.0 letter at 12 months but had decreased by 3.8 letters at 24 months (p=0.019) and by 4.1 letters (p=0.003) at 36 months. At 24 months, the result was significantly (p=0.030) less favourable when drop-outs were included. In patients enrolled during the late phase, BCVA had increased by 5.7 letters (p<0.0001) at three months and by 5.8 letters at 12 months (p=0.0016). In patients enrolled during the early phase, BCVA had increased by 3.5 letters (p=0.0008) at three months but had decreased by 2.3 letters (ns.) at 12 months. The result at 12 months was significantly (p=0.0033) better for the late than for the early phase. The number of injections was also significantly (p=0.011) higher in the late phase. Adverse events were similar to those in earlier clinical trials.
The initial average acuity could be maintained over 36 months, which is comparable to results of many other clinical cohorts. However, if the last available acuity of drop-outs was carried forward one step and included, the acuity figures fell significantly. The results in patients enrolled during the late phase of the study were fairly similar to those in clinical trials.
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