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DRCR.net Anti-VEGF Comparative Effectiveness Trial for Diabetic Macular Edema: Additional Post-Hoc Analyses

    Audio Abstracts: Anti-VEGF Comparative Effectiveness Trial for Diabetic Macular Edema: Additional Post-Hoc Analyses
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      Anti-VEGF Comparative Effectiveness Trial for Diabetic Macular Edema: Additional Post-Hoc Analyses

      Lee M. Jampol, MD, Adam R. Glassman, MS, Neil M. Bressler, MD, John A. Wells, MD, Allison R. Ayala MS

      JAMA Ophthalmol. 2016;134(12):1429-1434. doi:10.1001/jamaophthalmol.2016.3698

      Abstract

      Importance: Post-hoc analyses from DRCR.net randomized trial comparing aflibercept, bevacizumab, and ranibizumab for diabetic macular edema (DME) might influence interpretation of study results.

      Objective: To provide additional post-hoc clinically relevant outcomes comparing three anti-VEGF agents for DME

      Design, Setting, Participants: Post-hoc analysis from a 2-year randomized clinical trial of 660 participants comparing three anti-VEGF treatments in eyes with center-involved DME causing vision impairment.

      Exposure: Random allocation to intravitreous aflibercept (2.0-mg), bevacizumab (1.25-mg) or ranibizumab (0.3-mg) administered up to monthly based on a structured retreatment regimen.  Focal/grid laser was added after 6 months for persistent DME.

      Main Outcome Measures: Change in visual acuity area under the curve; change in central subfield thickness (CST) within subgroups based on whether an eye received laser treatment for DME during the study

      Results: For eyes with initial visual acuity (VA) 20/50 or worse, VA improvement was greater with aflibercept than the other agents at one year, but superior only to bevacizumab at the two year visit.  VA remained largely stable from one to two years (aflibercept: -1.2 letters [P=0.24]; bevacizumab: +0.3 letters [P=0.85]; ranibizumab: +1.1 letters [P=0.40]). Average letter change in VA over two years (area under curve) was greater with aflibercept (+17.1±9.7) than bevacizumab (+12.1±9.4, P<0.001) or ranibizumab (+13.6±8.5, P=0.009). When VA was 20/50 or worse, bevacizumab reduced CST less than the other agents at one year; but at two years the differences had diminished. Stratified analyses in this VA subgroup additionally stratified by whether focal/grid laser was given for DME during the study found a significant decrease in CST from one to two years only in bevacizumab-treated eyes receiving laser (-55um, P=0.0001).    

      Conclusions and Relevance: Although post-hoc analyses should be viewed with caution given the potential for bias, these results explore clinically relevant questions giving further information for interpretation of these comparative effectiveness results.

      Reviewed By

      Neil M. Bressler, MD                          
      James P. Gills Professor of Ophthalmology
      Chief of the Retina Division at The Wilmer Eye Institute
      Johns Hopkins University School of Medicine
      Baltimore, MD

      Diabetic Retinopathy Clinical Research Network retains the copyright to this image.

      To access the full article, click here

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