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Dante Pieramici, Ma'an Nasir, Alessandro Castellarin, Robert See, Steve Couvillion, Michael Bennett, Melvin Rabena, Jack Giust, Lisha Wan, Robert Avery; Ranibizumab 0.5mg and 2.0mg to Treat Diabetic Macular Edema in Patients With Poor Response to Bevacizumab. Invest. Ophthalmol. Vis. Sci. 2013;54(15):2413.
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To determine the efficacy of ranibizumab for residual or persistent diabetic macular edema in individuals with minimal or unresponsive to previous treatment for diabetic macular edema.
Prospective, nonrandomized single center interventional study. Individuals with residual center involved DME following bevacizumab treatment for DME were enrolled into this 12-month study. All enrolled subjects received at least two consecutive bevacizumab injections administered less than seven weeks apart. Upon enrollment, all patients received three consecutive monthly injections of 0.5mg ranibizumab. At Month 3, all subjects with residual macular edema were switched to three consecutive monthly injections of 2.0 mg ranibizumab. Monthly evaluations include standardized visual acuity, SD-OCT and complete ophthalmic evaluation. Fundus photos and FA were obtained quarterly.
Forty-three subjects with at least 6 months of follow-up were included in this analysis. Previous bevacizumab was adequate and consecutive prior to enrollment at an average of 36 days between bevacizumab injections. Mean VA was 59 letters at baseline; improved by +6.4 letters at Month 3 and +8.8 letters at Month 6. Mean central 1mm subfield thickness (CST) was 501µm at baseline; decreased by -114µm at Month 3 and -165µm at Month 6. Mean retinal volume decreased from 9.79 mm3 at baseline to 8.76 mm3 at Month 3 and 8.34 mm3 at Month 6. After 3 consecutive 0.5 mg ranibizumab injections, reduction in CST to below 300µm on SD-OCT was achieved in 20.9% (9/43) of subjects & CST decreased by >25% from baseline in 34.9% (15/43) of subjects. After 3 consecutive 2.0 mg ranibizumab injections, an additional 22.2% (6/27) of subjects achieved CST of ≤300µm & CST decreased by >25% from Month 3 in 29.6% (8/27) of subjects. One death due to acute hypoxemic respiratory failure was observed in the study.
Visual and anatomical improvement occurred in some patients with minimal or no response to previous bevacizumab therapy when switched to ranibizumab in an interim analysis of our investigator sponsored study. Incomplete or nonresponse to bevacizumab should not be a contraindication to considering ranibizumab therapy in patients with diabetic macular edema.
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