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N. J. London, A. E. Fung, P. U. Dugel, S. J. Bakri, R. E. Shaw, J. L. Miner, D. Y. Kunimoto; A Prospective Evaluation of Ranibizumab for Retinal Pigment Epithelial Detachments in Neovascular Age-related Macular Degeneration. Invest. Ophthalmol. Vis. Sci. 2009;50(13):2379.
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Because neovascular age-related macular degeneration (AMD) with retinal pigment epithelial detachments (PED) were excluded from the ranibizumab phase III studies, the behavior of and optimal regimen for PEDs treated with ranibizumab is poorly understood. This study prospectively evaluates ranibizumab for AMD with PED in 4 treatment strategies over one year.
IRB approvals and informed consents were obtained. In the monthly dosing arm, patients were randomized to either 0.3mg or 0.5mg ranibizumab monthly for 6 months then observation through one year. In the treat as needed (prn) arm, patients were randomized to three consecutive 0.5mg doses followed by either treatment until macular fluid was absent, or until both macular fluid and PED were absent. Data collected at monthly timepoints for visual acuity and retinal thickness were analyzed using Repeated Measures Analysis. Within subjects and between groups analyses were performed, and level of statistical significance set at p < 0.05. Missing values were imputed as the mean value between the two points adjacent to the missing data. All analyses were done using SPSS version 17.0 statistical software.
20 patients in the monthly arms and 9 patients in the prn arms have completed one year. In the monthly arms, mean VA at baseline, month 6 and month 12 in the 0.3mg group were 64, 67, and 64 letters respectively, and in the 0.5mg group were 63, 67, and 64 respectively (p=.996). In the prn arms, mean VA at baseline, month 6 and month 12 in the macular fluid only group were 47, 55, and 50 respectively, and in the macular fluid plus PED arm 47, 67, and 67 respectively (p=0.180). In the monthly arms mean CRT at baseline, months 6 and 12 in the 0.3mg group were 255, 235, and 246µm respectively, and in the 0.5mg group were 242, 203, and 199µm respectively (p=0.053). In the prn arms, mean CRT at baseline, months 6 and 12 in the macular fluid only group were 293, 238 and 317 respectively, and in the macular fluid plus PED arm 324, 198 and 186 respectively (p=0.014).Over one year, patients in the monthly arms received 6 injections each, and in the prn arms 9 (7-13) in the macular fluid group and 12 (7-13) in the macular fluid+PED group. The only adverse event was 1 RPE tear; no endophthalmitis or other injection related event was observed.
In this pilot study of ranibizumab for AMD with PED, a trend was observed towards better OCT outcomes with 0.5mg ranibizumab in the monthly arms, and towards better vision and OCT outcomes in the prn arm treated until both macular fluid and PEDs were absent.
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