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C. Pruente, K. Hatz, P. B. Henrich, B. Braun, S. Sacu, U. Schneider; A Randomized Double-masked Study Comparing Lucentis Monotherapy and PDT Combined With Lucentis Therapy in Patients With Exudative AMD: One Year Results for BCVA and Retreatment Frequency. Invest. Ophthalmol. Vis. Sci. 2009;50(13):5224.
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This double-blind monocenter study was designed to investigate the efficacy and safety of Lucentis (ranibizumab) monotherapy compared to standard verteporfin therapy in combination with Lucentis in all subtypes of CNV secondary to AMD during a one year follow-up.
Patients were randomized to receive initial PDT or sham PDT in both groups followed by 3 consecutive monthly intravitreal Lucentis 0.3mg injections. Thereafter, both groups received Lucentis injections on a PRN basis if disease activity was detectable based on loss of >5 ETDRS letters in BCVA or increase of retinal thickness by >100µm (OCT) to any prior visit.
21 patients in the monotherapy and 19 patients in the combination group were randomized. Mean age was 78.4 and 79.0 years respectively, central retinal thickness (CRT) 324 and 293 µm respectively and BCVA 52.1 letters in both groups. At one year BCVA increased significantly in both groups by 7.5±2.9 in the monotherapy and 9.0±2.8 letters in the combination group. However the course of vision gain during the follow-up period between the groups was significantly different with a less rapid increase for the combination group during the first 3 months. CRT decreased significantly by 101±25 and 89±24 µm respectively. Differences in between groups were not significant. A significant difference (p<0.05) was found for the need of re-treatment with a total of 45 re-treatments in the monotherapy and 19 re-treatments in the combination group. No ocular or systemic serious safety concerns were noted.
Both treatment strategies were equally potent in reducing CRT. In contrast, there was a non significant trend for less beneficial BCVA outcomes in the combination group with the use of standard PDT during the first 3 months following the initial combination treatment. These results suggest further investigations evaluating the effect of modified PDT parameters, the relevance of CNV subtypes in combination treatment and the timing of anti-VEGF treatment.
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