TY - JOUR
T1 - Panretinal Photocoagulation Versus Ranibizumab for Proliferative Diabetic Retinopathy
T2 - Factors Associated with Vision and Edema Outcomes
AU - Diabetic Retinopathy Clinical Research Network
AU - Bressler, Susan B.
AU - Beaulieu, Wesley T.
AU - Glassman, Adam R.
AU - Gross, Jeffrey G.
AU - Melia, Michele
AU - Chen, Eric
AU - Pavlica, Michael R.
AU - Jampol, Lee M.
N1 - Funding Information:
Supported through a cooperative agreement from the National Eye Institute and the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland (grant nos.: EY14231, EY23207, and EY18817). Genentech provided ranibizumab for the study and funds to Diabetic Retinopathy Clinical Research Network to defray the study’s clinical site costs. The Diabetic Retinopathy Clinical Research Network also received financial support from Allergan. The National Institutes of Health participated in oversight of the conduct of the study and review of the manuscript, but did not participate directly in the design or conduct of the study nor in the collection, management, analysis, or interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication. Per the Diabetic Retinopathy Clinical Research Network Industry Collaboration Guidelines (available at http://www.drcr.net ), the Diabetic Retinopathy Clinical Research Network had complete control over the design of the protocol and ownership of the data and all editorial content of presentations and publications related to the protocol.
Publisher Copyright:
© 2018 American Academy of Ophthalmology
PY - 2018/11
Y1 - 2018/11
N2 - Purpose: To identify baseline factors associated with change in visual acuity or development of vision-impairing central-involved diabetic macular edema (DME) over 2 years when treating proliferative diabetic retinopathy (PDR) with ranibizumab or panretinal photocoagulation (PRP). Design: Post hoc analyses of randomized, multicenter clinical trial data. Participants: Eyes completing the 2-year visit (n = 328) or without vision-impairing central-involved DME at baseline (n = 302) in Diabetic Retinopathy Clinical Research Network Protocol S. Methods: Intravitreous ranibizumab (0.5 mg/0.05 ml) or PRP. Main Outcome Measures: Change in visual acuity (area under the curve) and development of vision-impairing (20/32 or worse) central-involved DME over 2 years. Results: After multivariable model selection with adjustment for baseline visual acuity and central subfield thickness, no factors were identified as associated with change in visual acuity or development of vision-impairing central-involved DME within the ranibizumab group. In the PRP group, worse change in visual acuity was more likely with higher hemoglobin A1c level (–0.6 letters per 1% increase; 95% confidence interval [CI], –1.2 to –0.1 letters; continuous P = 0.03), more severe diabetic retinopathy (difference between high-risk PDR or worse vs. moderate PDR or better, –2.8 letters [95% CI, –5.5 to –0.2 letters]; continuous P = 0.003), and higher mean arterial pressure (difference between ≥100 mmHg vs. <100 mmHg, –2.0 letters [95% CI, –4.6 to 0.5 letters]; continuous P = 0.009). Development of vision-impairing central-involved DME was more likely with higher hemoglobin A1c level (hazard ratio [HR] per 1% increase, 1.31 [95% CI, 1.13–1.52]; continuous P < 0.001), more severe diabetic retinopathy (HR for high-risk PDR or worse vs. moderate PDR or better, 1.46 [95% CI, 0.73–2.92]; continuous P = 0.03), and the presence of cystoid abnormalities within 500 μm of the macula center (HR, 2.90 [95% CI, 1.35–6.24]; P = 0.006). Conclusions: For eyes managed with PRP, higher hemoglobin A1c level and more severe diabetic retinopathy were associated with less vision improvement and an increased risk of vision-impairing central-involved DME developing. When managing PDR with ranibizumab, eyes gained vision, on average, with no baseline characteristics identified as associated with visual acuity or central-involved DME outcomes.
AB - Purpose: To identify baseline factors associated with change in visual acuity or development of vision-impairing central-involved diabetic macular edema (DME) over 2 years when treating proliferative diabetic retinopathy (PDR) with ranibizumab or panretinal photocoagulation (PRP). Design: Post hoc analyses of randomized, multicenter clinical trial data. Participants: Eyes completing the 2-year visit (n = 328) or without vision-impairing central-involved DME at baseline (n = 302) in Diabetic Retinopathy Clinical Research Network Protocol S. Methods: Intravitreous ranibizumab (0.5 mg/0.05 ml) or PRP. Main Outcome Measures: Change in visual acuity (area under the curve) and development of vision-impairing (20/32 or worse) central-involved DME over 2 years. Results: After multivariable model selection with adjustment for baseline visual acuity and central subfield thickness, no factors were identified as associated with change in visual acuity or development of vision-impairing central-involved DME within the ranibizumab group. In the PRP group, worse change in visual acuity was more likely with higher hemoglobin A1c level (–0.6 letters per 1% increase; 95% confidence interval [CI], –1.2 to –0.1 letters; continuous P = 0.03), more severe diabetic retinopathy (difference between high-risk PDR or worse vs. moderate PDR or better, –2.8 letters [95% CI, –5.5 to –0.2 letters]; continuous P = 0.003), and higher mean arterial pressure (difference between ≥100 mmHg vs. <100 mmHg, –2.0 letters [95% CI, –4.6 to 0.5 letters]; continuous P = 0.009). Development of vision-impairing central-involved DME was more likely with higher hemoglobin A1c level (hazard ratio [HR] per 1% increase, 1.31 [95% CI, 1.13–1.52]; continuous P < 0.001), more severe diabetic retinopathy (HR for high-risk PDR or worse vs. moderate PDR or better, 1.46 [95% CI, 0.73–2.92]; continuous P = 0.03), and the presence of cystoid abnormalities within 500 μm of the macula center (HR, 2.90 [95% CI, 1.35–6.24]; P = 0.006). Conclusions: For eyes managed with PRP, higher hemoglobin A1c level and more severe diabetic retinopathy were associated with less vision improvement and an increased risk of vision-impairing central-involved DME developing. When managing PDR with ranibizumab, eyes gained vision, on average, with no baseline characteristics identified as associated with visual acuity or central-involved DME outcomes.
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U2 - 10.1016/j.ophtha.2018.04.039
DO - 10.1016/j.ophtha.2018.04.039
M3 - Article
C2 - 29980333
AN - SCOPUS:85049312001
VL - 125
SP - 1776
EP - 1783
JO - Ophthalmology
JF - Ophthalmology
SN - 0161-6420
IS - 11
ER -