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Rohit Varma, Neil Bressler, Chantal Dolan, Linda Yau, James Ward, Shoshana Colman; Baseline Predictors of improvement in self-reported visual function following treatment with ranibizumab in patients with diabetic macular edema. Invest. Ophthalmol. Vis. Sci. 2013;54(15):4026. doi: https://doi.org/.
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To identify predictors of improvement in patient-reported visual function following 24 months of every 4 week treatment with ranibizumab in patients with diabetic macular edema (DME) enrolled in the RIDE and RISE clinical trials.
Data from RIDE and RISE were pooled to identify predictors of overall composite score improvement from baseline to 24 months in patient-reported visual function measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25). Predictors were chosen from a set of 28 candidate variables considered to be potentially important predictors by the authors using two approaches: 1) a multivariate stepwise selection procedure from the full set of 28 candidate variables (P<0.05 criterion for inclusion) and 2) a univariate selection procedure identifying variables one at a time (P<0.10 criterion for inclusion) to be included in a final multivariate model utilizing stepwise selection procedure (p<0.05 criterion for inclusion). Parameter estimates and associated P-values for a combined screening model derived from (1) and (2) were obtained using the SAS GLM procedure.
There were 605 study participants with NEI VFQ-25 scores at both baseline and month 24. Predictors of improvement in patient-reported vision function in the combined screening model included the following: treatment with ranibizumab vs sham (P = 0.03), higher baseline contrast sensitivity in the untreated eye (P<0.001), lower baseline systolic blood pressure (P<0.03) and lower baseline NEI-VFQ-25 composite score (P<0.0001).
These data suggest that treatment with ranibizumab and lower self-reported visual function at baseline are associated with improved patient-reported visual function. No features have been identified which would preclude ranibizumab treatment for DME based on patient-reported visual function outcomes. Of particular note, baseline visual acuity in the treated eye does not necessarily predict improvement in self-reported visual function.
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