Abstract

To compare patient-centered outcomes in patients with proliferative diabetic retinopathy (PDR) treated with ranibizumab vs panretinal photocoagulation (PRP). Randomized clinical trial. Setting: Multicenter (55U.S. sites). Total of 216 adults with 1 study eye out of 305 adults (excluding participants with 2 study eyes, because each eye received a different treatment) with PDR, visual acuity 20/320 or better, no history of PRP. Ranibizumab (0.5mg/0.05mL) vs PRP. Change from baseline to 2 years in composite and prespecified subscale scores from the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25), University of Alabama Low Luminance Questionnaire (UAB-LLQ), and Work Productivity and Activity Impairment Questionnaire (WPAIQ). For the NEI VFQ-25 and UAB-LLQ composite scores, ranibizumab-PRP treatment group differences (95% CI) were+4.0 (-0.2,+8.3, P= .06) and+1.8 (-3.5,+7.1, P= 0.51) at 1 year, and+2.9 (-1.5,+7.2, P= .20) and+2.3 (-2.9,+7.5, P=.37) at 2 years, respectively. Work productivity loss measured with the WPAIQ was 15.6% less with ranibizumab (-26.3%,-4.8%, P= .005) at 1 year and 2.9% (-12.2%,+6.4%, P= .54) at 2 years. Eighty-three ranibizumab participants (97%) were 20/40 or better in at least 1 eye (visual acuity requirement to qualify for an unrestricted driver's license in many states) at2years compared with 82 PRP participants (87%, adjusted risk ratio= 1.1, 95% CI: 1.0, 1.2, P= .005). Though differences in some work productivity and driving-related outcomes favored ranibizumab over PRP, no differences between treatment regimens for PDR were identified for most of the otherpatient-centered outcomes considered.

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