OCALA EYE RETINA CONSULTANTS REGISTRATION
Trial Registration Identifier: NCT01909791 However, the eyes in the trial were approximately twice as likely to receive aflibercept for VA loss if they had greater baseline central subfield thickness, worse diabetic retinopathy severity level, or a nonstudy eye receiving treatment for DME.
OCALA EYE RETINA CONSULTANTS PLUS
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.Scientific Discovery and the Future of Medicine.
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