Panretinal Photocoagulation Versus Ranibizumab for Proliferative Diabetic Retinopathy: Patient-Centered Outcomes From a Randomized Clinical Trial

Abstract

Purpose: To compare patient-centered outcomes in patients with proliferative diabetic retinopathy (PDR) treated with ranibizumab vs panretinal photocoagulation (PRP).

Design: Randomized clinical trial.

Methods: Setting: Multicenter (55 U.S. sites).

Patient population: 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.

Intervention: Ranibizumab (0.5 mg/0.05 mL) vs PRP.

Main outcome measures: 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).

Results: 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) at 2 years compared with 82 PRP participants (87%, adjusted risk ratio = 1.1, 95% CI: 1.0, 1.2, P = .005).

Conclusions: 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 other patient-centered outcomes considered.

Copyright © 2016 Elsevier Inc. All rights reserved.

Figures

Figure 1

Treatment group differences, adjusted for baseline score and optical coherence tomography (OCT) central subfield thickness, between the ranibizumab and panretinal photocoagulation groups for the change from baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) composite score and subscales at the 1-year (Left) and 2-year visits (Right). Whiskers represent the 95% confidence interval for the composite score (black square) or 99% confidence intervals for the subscales (gray circles). Values above the dashed line favor the ranibizumab group while values below the dashed line favor the PRP group.

Figure 2

Treatment group differences, adjusted for baseline score and optical coherence tomography (OCT) central subfield thickness, between the ranibizumab and PRP groups for the change from baseline in the University of Alabama at Birmingham Low Luminance Questionnaire (UAB-LLQ) composite score and subscales at the 1-year (Left) and 2-year visits (Right). Whiskers represent the 95% confidence interval for the composite score (black square) or 99% confidence intervals for the subscales (gray circles). Values above the dashed line favor the ranibizumab group while values below the dashed line favor the PRP group.

Figure 3

Treatment group differences, adjusted for baseline score and optical coherence tomography (OCT) central subfield thickness, between the ranibizumab and PRP groups for the change from baseline in Work Productivity and Activity Impairment Questionnaire (WPAIQ) scores at the 1-year (Left) and 2-year visits (Right). Whiskers represent 99% confidence intervals. Values above the dashed line favor the PRP group while values below the dashed line favor the ranibizumab group.