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Pragmatism of randomized clinical trials on ranibizumab for the treatment of diabetic macular edema: Impact on clinical outcomes

Retina Apr 25, 2020

Stewart S, Yeong JL, Virgili G, et al. - In the present study, the researchers sought to assess the pragmatism and generalizability of randomized clinical trials (RCTs) on ranibizumab for diabetic macular edema and ascertain if clinical outcomes would vary based on whether or not patients fulfill the eligibility criteria of these RCTs. Using the PRECIS-2 tool, pragmatism and generalizability of three RCTs on ranibizumab for diabetic macular edema (DRCRnet Protocols I and T, and RESTORE) were rated. Of the 216 eyes (176 individuals) in the study, 63% would have met eligibility requirements for Protocol T, 61% for Protocol I, and 56% for RESTORE. RCTs were more pragmatic than explanatory, assessing ranibizumab for diabetic macular edema. Ranibizumab therapy still benefits "ineligible" patients.

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