Effects of intravitreal ranibizumab on retinal hard exudate in diabetic macular edema: findings from the RIDE and RISE phase III clinical trials.

摘要: Purpose To evaluate the effect of monthly intravitreal ranibizumab on hard exudate (HE) area and impact HE visual acuity (VA) outcomes in diabetic macular edema (DME) patients using data from 2 phase III clinical trials. Design Exploratory analyses III, randomized, double-masked, sham-controlled, multicenter Participants Adults with DME, baseline best-corrected VA 20/40 to 20/320 Snellen equivalent, central foveal thickness ≥275 μm. Methods Between studies, 759 DME were randomized receive 0.3 or 0.5 mg (Lucentis; Genentech, Inc., South San Francisco, CA) sham injections. Main Outcome Measures Hard was assessed color fundus stereophotographs both an ordinal scale continuous estimates areas within Early Treatment Diabetic Retinopathy Study grid. Results Data 739 eyes available for analysis. Mean similar across treatment groups, ranging 0.65 0.82 mm . Through month 24, percentage without increased 20.9% 36.3% group 22.1% 61.3% 23.6% 62.0% 0.3-mg 0.5-mg respectively. Resolution became apparent sometime after 6 ranibizumab-treated eyes. At baseline, there no meaningful correlation between presence absence HE. After also consistent change over time. Conclusions In this exploratory analysis, resulted significantly greater reduction compared ( P