![]() Receipt of aflibercept was more likely in eyes with baseline central subfield thickness at least 300 μm (Zeiss-Stratus equivalent) vs less than 300 μm (45% vs 26% hazard ratio, 1.98, continuous P = .005), moderately severe nonproliferative diabetic retinopathy (Early Treatment Diabetic Retinopathy Study retinopathy severity level 47) and above vs moderate nonproliferative diabetic retinopathy (retinopathy severity level 43) and below (51% vs 27% HR, 2.22, ordinal P < .001), and among participants whose nonstudy eye received DME treatment within 4 months of randomization vs not (52% vs 25% HR, 2.55, P < .001).Ĭonclusions and Relevance Most eyes managed with initial observation plus aflibercept only if VA worsened maintained good vision at 2 years and did not require aflibercept for VA loss. At 2 years, the median VA letter score was 86.0 (interquartile range, 89.0-81.0 median Snellen equivalent, 20/20 ). Results Among 236 eyes in 236 individuals (149 male median age, 60 years ) randomly assigned to initial observation, 80 (34%) were treated with aflibercept during 2 years of follow-up. Main Outcomes and Measures Whether individuals received aflibercept. Follow-up occurred at 8 weeks and then every 16 weeks unless VA or optical coherence tomography central subfield thickness worsened. ![]() Interventions Initial observation and follow-up with aflibercept only for VA loss of at least 10 letters from baseline at 1 visit or 5 to 9 letters at 2 consecutive visits. Data were analyzed from March 2019 to November 2019. Participants were adults (n = 236) with type 1 or 2 diabetes, 1 study eye with CI-DME, and VA letter score at least 79 (Snellen equivalent, 20/25 or better) assigned to initial observation. Objective To assess the DRCR Retina Network protocol-defined approach and outcomes of initial observation with aflibercept only if VA worsened.ĭesign, Setting, and Participants This was a post hoc secondary analyses of a randomized clinical trial of the DRCR Retina Network Protocol V that included 91 US and Canadian sites from November 2013 to September 2018. Understanding the initial observation approach is relevant to patient management. Importance Among eyes with center-involved diabetic macular edema (CI-DME) and good visual acuity (VA), randomized clinical trial results showed no difference in VA loss between initial observation plus aflibercept only if VA decreased, initial focal/grid laser plus aflibercept only if VA decreased, or prompt aflibercept. Shared Decision Making and Communication. ![]() ![]()
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