Rationale and Application of the Protocol S Anti–Vascular Endothelial Growth Factor Algorithm for Proliferative Diabetic Retinopathy

Diabetic Retinopathy Clinical Research Network

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
JournalOphthalmology
DOIs
StateAccepted/In press - Jan 1 2018

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Endothelial Growth Factors
Diabetic Retinopathy
Light Coagulation
Injections
Medical Futility
Therapeutics
Vascular Endothelial Growth Factor A
Patient Compliance
Clinical Protocols
Randomized Controlled Trials
Outcome Assessment (Health Care)
Guidelines

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Rationale and Application of the Protocol S Anti–Vascular Endothelial Growth Factor Algorithm for Proliferative Diabetic Retinopathy. / Diabetic Retinopathy Clinical Research Network.

In: Ophthalmology, 01.01.2018.

Research output: Contribution to journalArticle

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title = "Rationale and Application of the Protocol S Anti–Vascular Endothelial Growth Factor Algorithm for Proliferative Diabetic Retinopathy",
abstract = "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.",
author = "{Diabetic Retinopathy Clinical Research Network} and Sun, {Jennifer K.} and Glassman, {Adam R.} and Beaulieu, {Wesley T.} and Stockdale, {Cynthia R.} and Bressler, {Neil M.} and Christina Flaxel and Gross, {Jeffrey G.} and Michel Shami and Jampol, {Lee M.}",
year = "2018",
month = "1",
day = "1",
doi = "10.1016/j.ophtha.2018.08.001",
language = "English (US)",
journal = "Ophthalmology",
issn = "0161-6420",
publisher = "Elsevier Inc.",

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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.

PY - 2018/1/1

Y1 - 2018/1/1

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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