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jean paul bellamy, Gérard Mimoun, Eric H Souied, Hassiba Oubraham, Catherine Français, Franck Rumen, Marie-Laure Lelez, Elisabeth Hermouet, Laetitia Finzi, Salomon Y Cohen; Early and delayed visual acuity responders to ranibizumab in patients with neovascular age-related macular degeneration: a retrospective pooled analysis from the real-world LUMIERE and TWIN studies. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):2823.
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In clinical trials, the proportion of early ≥15 letter gainers at Month 3 ranged from 18% to 29% with ranibizumab treatment in patients with neovascular age-related macular degeneration (nAMD). A retrospective pooled analysis from the LUMIERE and TWIN studies aimed to identify the early and delayed visual acuity (VA) responders, and the possible predictors of response to ranibizumab treatment in real-world practice in nAMD.
LUMIERE and TWIN were 12 month, retrospective purely observational studies conducted in clinical settings to evaluate the functional and morphological outcomes with ranibizumab treatment in patients with nAMD. The analyzed population (N=401) consisted of patients who received a loading phase with 3 monthly ranibizumab injections and had at least one VA assessment one month after the third injection. Based on the treatment’s response, patients were categorized as 'early responders' (gain of ≥15 letters at Month 3 from baseline) or ‘delayed responders' (did not gain ≥15 letters at Month 3 but did at Month 12 from baseline). The evaluation included proportions of 'early responders' and ‘delayed responders', and comparisons of 'early responders' vs ‘delayed responders', and comparisons of the two groups accordingly to their baseline characteristics.
Overall, 18.9% (76/401) patients were early responders. Of the 325 who were not categorized as early responders, 10.5% (34/325) were delayed responders. At baseline, the mean VA for early responders was significantly lower compared to delayed responders (40.4 vs 51.6 letters, p<0.001). The two groups presented mostly occult choroidal neovascularization at baseline (59.7% and 50%) and 30.3% of early responders and 44.1% of delayed responders were reported with vascularized pigment epithelium detachment (Table 1).
This retrospective pooled analysis from LUMIERE and TWIN studies suggests that maintaining ranibizumab treatment can result in VA improvements in the subgroup of delayed responders. These “real-world” data are in agreement with those of clinical trials, indicating that ranibizumab in real-word wAMD patients receiving the loading phase is as effective as in clinical trials.
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