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Brandon G. Busbee, Anne E. Fung, John W. Kitchens, Brandon J. Lujan, Jan Kristine Bayabo, Richard E. Shaw; OCT response to 2mg ranibizumab for AMD Pigment Epithelial Detachments refractory to conventional dosing in the HiPED study. Invest. Ophthalmol. Vis. Sci. 2012;53(14):2041.
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The High dose ranibizumab for Pigment Epithelial Detachment (HiPED) Study enrolled wet age-related macular degeneration (AMD) patients with fibrovascular pigment epithelial detachments (PED) that remained after 6 consecutive injections of standard dose ranibizumab and/or bevacizumab. Changes in macular thickness as imaged with spectral domain optical coherence tomography (SDOCT) in these patients treated with monthly 2mg ranibizumab were evaluated. We hypothesized that the higher 2mg ranibizumab dosing would further decrease macular thickness towards a normal range when compared with the previous therapies.
The HiPED protocol was granted approval by the CPMC IRB and conducted in compliance with the Declaration of Helsinki. Consented subjects were enrolled into this randomized, prospective open-label, multi-center, investigator sponsored study for 24 months. At each visit, visual acuity, dilated fundus exam, and SDOCT were performed. Subjects were randomized to either Group 1: 2mg ranibizumab injections monthly or Group 2: 2mg injections x 3 monthly injections followed by as needed (PRN) injections for presence of any macular fluid or PED on SDOCT. Cirrus HD-OCT (Carl Zeiss, Dublin CA, software version 6.0) cube scans were obtained monthly with standard office protocols. Quantitative measurements of the central subfield thickness (CST) and qualitative assessments by the investigators were made for presence of PED. Correlations between these metrics and VA were calculated. Paired t-test analysis was conducted using SPSS.
37 patients were enrolled. 31 patients have completed 6 months (19 Group 1 and 18 Group 2), and 13 patients have completed one year (8 Group 1, and 5 Group 2). All subjects received monthly injections through one year due to the persistence of a PED. Mean baseline CST was 280 microns. Mean CST was significantly reduced to 241 microns at month 6 (n=31, p=0.001) and 239 microns at month 12 (n=13, p=0.01).
A further reduction in CST was observed over the course of the study in all patients and was statistically significant. Furthermore, PED continued to be present throughout the study despite improvement in VA, reduction in CST and near monthly treatment with 2mg ranibizumab.
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