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M. B. Eldem, K.-U. Bartz-Schmidt, R. O. Schlingemann, R. Guymer, R. Axer-Siegel, on behalf of the EXCITE study group; Visual Acuity Response Profiles in Patients With Neovascular Age-related Macular Degeneration Treated Quarterly With Ranibizumab in the EXCITE Trial. Invest. Ophthalmol. Vis. Sci. 2009;50(13):2374.
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To describe sub-group visual acuity response profiles of patients with neovascular age-related macular degeneration (AMD) treated quarterly with ranibizumab over 12 months.
In the double-masked, active-controlled, multi-center EXCITE study, AMD patients were randomized into 3 treatment groups: (1) 3 initial monthly injections (loading phase) followed by quarterly injections of 0.3 mg ranibizumab (n=120), (2) loading phase and quarterly injections of 0.5 mg ranibizumab (n=118), and (3) monthly injections of 0.3 mg ranibizumab (n=115). Best-corrected visual acuity (BCVA) was assessed monthly using Early Treatment for Diabetic Retinopathy Study charts. BCVA response profiles were analyzed for quarterly treated patients (last observation carried forward to Month 12).
In the quarterly treatment groups BCVA increased from baseline to Month 12 by 4.0 letters (0.3 mg), 2.8 letters (0.5 mg), and 3.4 letters (pooled). Among these patients, the following 3 responder types were identified: (1) patients (n=99) who maintained an initial BCVA gain and whose BCVA remained stable with no apparent reaction to single ranibizumab injections, (2) patients (n=80) whose initial BCVA gain was not maintained and whose BCVA was unstable with BCVA gain reactions to single ranibizumab injections being insufficient to compensate previous BCVA loss, and (3) patients (n=44) who had no initial BCVA gain with no apparent BCVA gain reactions to single ranibizumab injections and almost stable BCVA.
The results indicate that about 40% of patients were ‘sufficiently treated’ by quarterly ranibizumab injections. The baseline characteristics of these patients in relation to their response profiles remain to be further investigated.
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