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Raafay Sophie, Na Lu, Peter A Campochiaro; Baseline predictors of functional outcomes in patients with diabetic macular edema (DME) in the RISE and RIDE trials. Invest. Ophthalmol. Vis. Sci. 2014;55(13):1702.
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© ARVO (1962-2015); The Authors (2016-present)
To identify predictors of visual and anatomic outcomes in ranibizumab- and sham-treated DME patients in the RISE and RIDE trials.
In 502 ranibizumab-treated and 257 sham-treated subjects, predictors from univariate logistic regression with p<0.20 were carried forward in a multivariate regression model. Those with p<0.05 were retained using backward selection. Outcome measures 24 months after baseline included best corrected visual acuity (BCVA) ≥20/40 (70 ETDRS letters), BCVA gain ≥15 letters, BCVA ≤20/100 (50 letters), BCVA loss ≥15 letters, and central foveal thickness (CFT) ≤250µm.
In ranibizumab-treated subjects, young age and presence of subretinal fluid were predictive of BCVA gain ≥15 letters and BCVA ≥20/40. Poor baseline BCVA was predictive of BCVA gain ≥15 letters and BCVA ≤20/100, while good BCVA at baseline predicted BCVA ≥20/40. Prior or during-study panretinal photocoagulation (PRP) predicted BCVA <20/40. Low CFT, subretinal fluid and small vs. large cysts predicted CFT≤250µm. In sham-treated subjects, young age and low baseline CFT predicted BCVA gain ≥15 letters and BCVA ≥20/40; BCVA gain ≥15 letters and BCVA ≥20/40 were associated with poor and good baseline BCVA, respectively. Renal disease predicted BCVA <20/40. Low baseline CFT, poor baseline BCVA, prior or during- study PRP, and statin use predicted CFT≤250. Low baseline BCVA, renal disease, and large vs. small cysts predicted BCVA ≤20/100.
In ranibizumab- or sham-treated subjects, young age and baseline BCVA predicted good visual outcome. Subretinal fluid predicted good outcome in ranibizumab-treated and poor outcome in sham-treated subjects. Absence of severe thickening or large cysts at baseline was important to obtain good visual outcome in sham-treated but not ranibizumab-treated subjects. Renal disease predicted a poor outcome in sham-treated but not ranibizumab-treated subjects. These data suggest that delayed ranibizumab treatment has greater negative consequences in DME patients with subretinal fluid, severe edema, large cysts, or renal disease.
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