TY - JOUR
T1 - Rationale and Application of the Protocol S Anti–Vascular Endothelial Growth Factor Algorithm for Proliferative Diabetic Retinopathy
AU - Diabetic Retinopathy Clinical Research Network
AU - Sun, Jennifer K.
AU - Glassman, Adam R.
AU - Beaulieu, Wesley T.
AU - Stockdale, Cynthia R.
AU - Bressler, Neil M.
AU - Flaxel, Christina
AU - Gross, Jeffrey G.
AU - Shami, Michel
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 [A.R.G.], EY23207 [L.M.J.], and EY18817 [N.M.B.]); and the Juvenile Diabetes Research Foundation. Genentech provided ranibizumab for the study and funds to DRCR.net to defray the study's clinical site costs. The National Institutes of Health participated in oversight of the conduct of the study and review of the manuscript, but not 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; nor decision to submit the manuscript for publication. Per the DRCR.net Industry Collaboration Guidelines (available at http://www.drcr.net), the DRCR.net had complete control over the design of the protocol, ownership of the data, and all editorial content of presentations and publications related to the protocol.
Publisher Copyright:
© 2018 American Academy of Ophthalmology
PY - 2019/1
Y1 - 2019/1
N2 - Purpose: To present the rationale, guidelines, and results of ranibizumab treatment for proliferative diabetic retinopathy (PDR) in Diabetic Retinopathy Clinical Research Network (DRCR.net) Protocol S. Design: Post hoc analyses from a randomized clinical trial. Participants: Three hundred five participants (394 study eyes) having PDR without prior panretinal photocoagulation (PRP). Methods: Intravitreous ranibizumab (0.5 mg) versus PRP for PDR. Ranbizumab-assigned eyes (n = 191) received monthly injections for 6 months unless resolution was achieved after 4 injections. After 6 months, injections could be deferred if neovascularization was stable over 3 consecutive visits (sustained stability). If neovascularization worsened, monthly treatment resumed. Panretinal photocoagulation could be initiated for failure or futility criteria. Main Outcome Measures: Neovascularization status through 2 years. Results: At 1 month, 19% (35 of 188) of ranibizumab-assigned eyes showed complete neovascularization resolution and an additional 60% (113) showed improvement. At 6 months, 52% (80 of 153) showed neovascularization resolution, 3% (4) were improved, 37% (56) were stable, and 8% (13) had worsened since the last visit. Among eyes with versus without resolved neovascularization at 6 months, the median (interquartile range) number of injections between 6 months and 2 years was 4 (1–7; n = 73) versus 7 (4–11; n = 67; P < 0.001). Injections were deferred in 68 of 73 eyes (93%) meeting sustained stability at least once during the study; 62% (42 of 68) resumed injections within 16 weeks after deferral. At 2 years, 43% (66 of 154) showed neovascularization resolution, 5% (7) showed improvement, 23% (36) were stable, and 27% (42) had worsened since the last visit. Only 3 eyes met criteria for failure or futility through 2 years. Conclusions: The DRCR.net treatment algorithm for PDR can provide excellent clinical outcomes through 2 years for patients initiating anti–vascular endothelial growth factor (VEGF) therapy for PDR. When choosing between anti-VEGF and PRP as first-line therapy for PDR, treatment decisions should be guided by consideration of the relative advantages of each therapeutic method and anticipated patient compliance with follow-up and treatment recommendations.
AB - Purpose: To present the rationale, guidelines, and results of ranibizumab treatment for proliferative diabetic retinopathy (PDR) in Diabetic Retinopathy Clinical Research Network (DRCR.net) Protocol S. Design: Post hoc analyses from a randomized clinical trial. Participants: Three hundred five participants (394 study eyes) having PDR without prior panretinal photocoagulation (PRP). Methods: Intravitreous ranibizumab (0.5 mg) versus PRP for PDR. Ranbizumab-assigned eyes (n = 191) received monthly injections for 6 months unless resolution was achieved after 4 injections. After 6 months, injections could be deferred if neovascularization was stable over 3 consecutive visits (sustained stability). If neovascularization worsened, monthly treatment resumed. Panretinal photocoagulation could be initiated for failure or futility criteria. Main Outcome Measures: Neovascularization status through 2 years. Results: At 1 month, 19% (35 of 188) of ranibizumab-assigned eyes showed complete neovascularization resolution and an additional 60% (113) showed improvement. At 6 months, 52% (80 of 153) showed neovascularization resolution, 3% (4) were improved, 37% (56) were stable, and 8% (13) had worsened since the last visit. Among eyes with versus without resolved neovascularization at 6 months, the median (interquartile range) number of injections between 6 months and 2 years was 4 (1–7; n = 73) versus 7 (4–11; n = 67; P < 0.001). Injections were deferred in 68 of 73 eyes (93%) meeting sustained stability at least once during the study; 62% (42 of 68) resumed injections within 16 weeks after deferral. At 2 years, 43% (66 of 154) showed neovascularization resolution, 5% (7) showed improvement, 23% (36) were stable, and 27% (42) had worsened since the last visit. Only 3 eyes met criteria for failure or futility through 2 years. Conclusions: The DRCR.net treatment algorithm for PDR can provide excellent clinical outcomes through 2 years for patients initiating anti–vascular endothelial growth factor (VEGF) therapy for PDR. When choosing between anti-VEGF and PRP as first-line therapy for PDR, treatment decisions should be guided by consideration of the relative advantages of each therapeutic method and anticipated patient compliance with follow-up and treatment recommendations.
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U2 - 10.1016/j.ophtha.2018.08.001
DO - 10.1016/j.ophtha.2018.08.001
M3 - Article
C2 - 30096354
AN - SCOPUS:85053836012
SN - 0161-6420
VL - 126
SP - 87
EP - 95
JO - Ophthalmology
JF - Ophthalmology
IS - 1
ER -