A prospective randomized trial of intravitreal bevacizumab or laser therapy in the management of diabetic macular edema (BOLT study) 12-month data: report 2

Michel Michaelides; Andrew Kaines; Robin D Hamilton; Samantha Fraser-Bell; Ranjan Rajendram; Fahd Quhill; Christopher J Boos; Wen Xing; Catherine Egan; Tunde Peto; Catey Bunce; R David Leslie; Philip G Hykin

doi:10.1016/j.ophtha.2010.03.045

A prospective randomized trial of intravitreal bevacizumab or laser therapy in the management of diabetic macular edema (BOLT study) 12-month data: report 2

Michel Michaelides, Andrew Kaines, Robin D Hamilton, Samantha Fraser-Bell, Ranjan Rajendram, Fahd Quhill, Christopher J Boos, Wen Xing, Catherine Egan, Tunde Peto, Catey Bunce, R David Leslie, Philip G Hykin

School of Medicine, Dentistry and Biomedical Sciences

Research output: Contribution to journal › Article › peer-review

442 Citations (Scopus)

Abstract

PURPOSE: To report the findings at 1 year of a study comparing repeated intravitreal bevacizumab (ivB) and modified Early Treatment of Diabetic Retinopathy Study (ETDRS) macular laser therapy (MLT) in patients with persistent clinically significant diabetic macular edema (CSME).

DESIGN: Prospective, randomized, masked, single-center, 2-year, 2-arm clinical trial.

PARTICIPANTS: A total of 80 eyes of 80 patients with center-involving CSME and at least 1 prior MLT.

METHODS: Subjects were randomized to either ivB (6 weekly; minimum of 3 injections and maximum of 9 injections in the first 12 months) or MLT (4 monthly; minimum of 1 treatment and maximum of 4 treatments in the first 12 months).

MAIN OUTCOME MEASURES: The primary end point was the difference in ETDRS best-corrected visual acuity (BCVA) at 12 months between the bevacizumab and laser arms.

RESULTS: The baseline mean ETDRS BCVA was 55.7+/-9.7 (range 34-69) in the bevacizumab group and 54.6+/-8.6 (range 36-68) in the laser arm. The mean ETDRS BCVA at 12 months was 61.3+/-10.4 (range 34-79) in the bevacizumab group and 50.0+/-16.6 (range 8-76) in the laser arm (P = 0.0006). Furthermore, the bevacizumab group gained a median of 8 ETDRS letters, whereas the laser group lost a median of 0.5 ETDRS letters (P = 0.0002). The odds of gaining > or =10 ETDRS letters over 12 months were 5.1 times greater in the bevacizumab group than in the laser group (adjusted odds ratio, 5.1; 95% confidence interval, 1.3-19.7; P = 0.019). At 12 months, central macular thickness decreased from 507+/-145 microm (range 281-900 microm) at baseline to 378+/-134 microm (range 167-699 microm) (P<0.001) in the ivB group, whereas it decreased to a lesser extent in the laser group, from 481+/-121 microm (range 279-844 microm) to 413+/-135 microm (range 170-708 microm) (P = 0.02). The median number of injections was 9 (interquartile range [IQR] 8-9) in the ivB group, and the median number of laser treatments was 3 (IQR 2-4) in the MLT group.

CONCLUSIONS: The study provides evidence to support the use of bevacizumab in patients with center-involving CSME without advanced macular ischemia.

Original language	English
Pages (from-to)	1078-1086.e2
Journal	Ophthalmology
Volume	117
Issue number	6
DOIs	https://doi.org/10.1016/j.ophtha.2010.03.045
Publication status	Published - Jun 2010

Keywords

Adult
Aged
Aged, 80 and over
Angiogenesis Inhibitors
Antibodies, Monoclonal
Antibodies, Monoclonal, Humanized
Bevacizumab
Diabetic Retinopathy
Double-Blind Method
Female
Fluorescein Angiography
Humans
Injections
Laser Coagulation
Macular Edema
Male
Middle Aged
Prospective Studies
Retreatment
Treatment Outcome
Vascular Endothelial Growth Factor A
Visual Acuity
Vitreous Body
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.ophtha.2010.03.045

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Michaelides, M., Kaines, A., Hamilton, R. D., Fraser-Bell, S., Rajendram, R., Quhill, F., Boos, C. J., Xing, W., Egan, C., Peto, T., Bunce, C., Leslie, R. D., & Hykin, P. G. (2010). A prospective randomized trial of intravitreal bevacizumab or laser therapy in the management of diabetic macular edema (BOLT study) 12-month data: report 2. Ophthalmology, 117(6), 1078-1086.e2. https://doi.org/10.1016/j.ophtha.2010.03.045

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title = "A prospective randomized trial of intravitreal bevacizumab or laser therapy in the management of diabetic macular edema (BOLT study) 12-month data: report 2",

abstract = "PURPOSE: To report the findings at 1 year of a study comparing repeated intravitreal bevacizumab (ivB) and modified Early Treatment of Diabetic Retinopathy Study (ETDRS) macular laser therapy (MLT) in patients with persistent clinically significant diabetic macular edema (CSME).DESIGN: Prospective, randomized, masked, single-center, 2-year, 2-arm clinical trial.PARTICIPANTS: A total of 80 eyes of 80 patients with center-involving CSME and at least 1 prior MLT.METHODS: Subjects were randomized to either ivB (6 weekly; minimum of 3 injections and maximum of 9 injections in the first 12 months) or MLT (4 monthly; minimum of 1 treatment and maximum of 4 treatments in the first 12 months).MAIN OUTCOME MEASURES: The primary end point was the difference in ETDRS best-corrected visual acuity (BCVA) at 12 months between the bevacizumab and laser arms.RESULTS: The baseline mean ETDRS BCVA was 55.7+/-9.7 (range 34-69) in the bevacizumab group and 54.6+/-8.6 (range 36-68) in the laser arm. The mean ETDRS BCVA at 12 months was 61.3+/-10.4 (range 34-79) in the bevacizumab group and 50.0+/-16.6 (range 8-76) in the laser arm (P = 0.0006). Furthermore, the bevacizumab group gained a median of 8 ETDRS letters, whereas the laser group lost a median of 0.5 ETDRS letters (P = 0.0002). The odds of gaining > or =10 ETDRS letters over 12 months were 5.1 times greater in the bevacizumab group than in the laser group (adjusted odds ratio, 5.1; 95% confidence interval, 1.3-19.7; P = 0.019). At 12 months, central macular thickness decreased from 507+/-145 microm (range 281-900 microm) at baseline to 378+/-134 microm (range 167-699 microm) (P<0.001) in the ivB group, whereas it decreased to a lesser extent in the laser group, from 481+/-121 microm (range 279-844 microm) to 413+/-135 microm (range 170-708 microm) (P = 0.02). The median number of injections was 9 (interquartile range [IQR] 8-9) in the ivB group, and the median number of laser treatments was 3 (IQR 2-4) in the MLT group.CONCLUSIONS: The study provides evidence to support the use of bevacizumab in patients with center-involving CSME without advanced macular ischemia.",

keywords = "Adult, Aged, Aged, 80 and over, Angiogenesis Inhibitors, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Bevacizumab, Diabetic Retinopathy, Double-Blind Method, Female, Fluorescein Angiography, Humans, Injections, Laser Coagulation, Macular Edema, Male, Middle Aged, Prospective Studies, Retreatment, Treatment Outcome, Vascular Endothelial Growth Factor A, Visual Acuity, Vitreous Body, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't",

author = "Michel Michaelides and Andrew Kaines and Hamilton, {Robin D} and Samantha Fraser-Bell and Ranjan Rajendram and Fahd Quhill and Boos, {Christopher J} and Wen Xing and Catherine Egan and Tunde Peto and Catey Bunce and Leslie, {R David} and Hykin, {Philip G}",

year = "2010",

month = jun,

doi = "10.1016/j.ophtha.2010.03.045",

language = "English",

volume = "117",

pages = "1078--1086.e2",

journal = "Ophthalmology",

issn = "0161-6420",

publisher = "Elsevier Inc.",

number = "6",

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Michaelides, M, Kaines, A, Hamilton, RD, Fraser-Bell, S, Rajendram, R, Quhill, F, Boos, CJ, Xing, W, Egan, C, Peto, T, Bunce, C, Leslie, RD & Hykin, PG 2010, 'A prospective randomized trial of intravitreal bevacizumab or laser therapy in the management of diabetic macular edema (BOLT study) 12-month data: report 2', Ophthalmology, vol. 117, no. 6, pp. 1078-1086.e2. https://doi.org/10.1016/j.ophtha.2010.03.045

TY - JOUR

T1 - A prospective randomized trial of intravitreal bevacizumab or laser therapy in the management of diabetic macular edema (BOLT study) 12-month data

T2 - report 2

AU - Michaelides, Michel

AU - Kaines, Andrew

AU - Hamilton, Robin D

AU - Fraser-Bell, Samantha

AU - Rajendram, Ranjan

AU - Quhill, Fahd

AU - Boos, Christopher J

AU - Xing, Wen

AU - Egan, Catherine

AU - Peto, Tunde

AU - Bunce, Catey

AU - Leslie, R David

AU - Hykin, Philip G

PY - 2010/6

Y1 - 2010/6

N2 - PURPOSE: To report the findings at 1 year of a study comparing repeated intravitreal bevacizumab (ivB) and modified Early Treatment of Diabetic Retinopathy Study (ETDRS) macular laser therapy (MLT) in patients with persistent clinically significant diabetic macular edema (CSME).DESIGN: Prospective, randomized, masked, single-center, 2-year, 2-arm clinical trial.PARTICIPANTS: A total of 80 eyes of 80 patients with center-involving CSME and at least 1 prior MLT.METHODS: Subjects were randomized to either ivB (6 weekly; minimum of 3 injections and maximum of 9 injections in the first 12 months) or MLT (4 monthly; minimum of 1 treatment and maximum of 4 treatments in the first 12 months).MAIN OUTCOME MEASURES: The primary end point was the difference in ETDRS best-corrected visual acuity (BCVA) at 12 months between the bevacizumab and laser arms.RESULTS: The baseline mean ETDRS BCVA was 55.7+/-9.7 (range 34-69) in the bevacizumab group and 54.6+/-8.6 (range 36-68) in the laser arm. The mean ETDRS BCVA at 12 months was 61.3+/-10.4 (range 34-79) in the bevacizumab group and 50.0+/-16.6 (range 8-76) in the laser arm (P = 0.0006). Furthermore, the bevacizumab group gained a median of 8 ETDRS letters, whereas the laser group lost a median of 0.5 ETDRS letters (P = 0.0002). The odds of gaining > or =10 ETDRS letters over 12 months were 5.1 times greater in the bevacizumab group than in the laser group (adjusted odds ratio, 5.1; 95% confidence interval, 1.3-19.7; P = 0.019). At 12 months, central macular thickness decreased from 507+/-145 microm (range 281-900 microm) at baseline to 378+/-134 microm (range 167-699 microm) (P<0.001) in the ivB group, whereas it decreased to a lesser extent in the laser group, from 481+/-121 microm (range 279-844 microm) to 413+/-135 microm (range 170-708 microm) (P = 0.02). The median number of injections was 9 (interquartile range [IQR] 8-9) in the ivB group, and the median number of laser treatments was 3 (IQR 2-4) in the MLT group.CONCLUSIONS: The study provides evidence to support the use of bevacizumab in patients with center-involving CSME without advanced macular ischemia.

AB - PURPOSE: To report the findings at 1 year of a study comparing repeated intravitreal bevacizumab (ivB) and modified Early Treatment of Diabetic Retinopathy Study (ETDRS) macular laser therapy (MLT) in patients with persistent clinically significant diabetic macular edema (CSME).DESIGN: Prospective, randomized, masked, single-center, 2-year, 2-arm clinical trial.PARTICIPANTS: A total of 80 eyes of 80 patients with center-involving CSME and at least 1 prior MLT.METHODS: Subjects were randomized to either ivB (6 weekly; minimum of 3 injections and maximum of 9 injections in the first 12 months) or MLT (4 monthly; minimum of 1 treatment and maximum of 4 treatments in the first 12 months).MAIN OUTCOME MEASURES: The primary end point was the difference in ETDRS best-corrected visual acuity (BCVA) at 12 months between the bevacizumab and laser arms.RESULTS: The baseline mean ETDRS BCVA was 55.7+/-9.7 (range 34-69) in the bevacizumab group and 54.6+/-8.6 (range 36-68) in the laser arm. The mean ETDRS BCVA at 12 months was 61.3+/-10.4 (range 34-79) in the bevacizumab group and 50.0+/-16.6 (range 8-76) in the laser arm (P = 0.0006). Furthermore, the bevacizumab group gained a median of 8 ETDRS letters, whereas the laser group lost a median of 0.5 ETDRS letters (P = 0.0002). The odds of gaining > or =10 ETDRS letters over 12 months were 5.1 times greater in the bevacizumab group than in the laser group (adjusted odds ratio, 5.1; 95% confidence interval, 1.3-19.7; P = 0.019). At 12 months, central macular thickness decreased from 507+/-145 microm (range 281-900 microm) at baseline to 378+/-134 microm (range 167-699 microm) (P<0.001) in the ivB group, whereas it decreased to a lesser extent in the laser group, from 481+/-121 microm (range 279-844 microm) to 413+/-135 microm (range 170-708 microm) (P = 0.02). The median number of injections was 9 (interquartile range [IQR] 8-9) in the ivB group, and the median number of laser treatments was 3 (IQR 2-4) in the MLT group.CONCLUSIONS: The study provides evidence to support the use of bevacizumab in patients with center-involving CSME without advanced macular ischemia.

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Angiogenesis Inhibitors

KW - Antibodies, Monoclonal

KW - Antibodies, Monoclonal, Humanized

KW - Bevacizumab

KW - Diabetic Retinopathy

KW - Double-Blind Method

KW - Female

KW - Fluorescein Angiography

KW - Humans

KW - Injections

KW - Laser Coagulation

KW - Macular Edema

KW - Male

KW - Middle Aged

KW - Prospective Studies

KW - Retreatment

KW - Treatment Outcome

KW - Vascular Endothelial Growth Factor A

KW - Visual Acuity

KW - Vitreous Body

KW - Comparative Study

KW - Journal Article

KW - Randomized Controlled Trial

KW - Research Support, Non-U.S. Gov't

U2 - 10.1016/j.ophtha.2010.03.045

DO - 10.1016/j.ophtha.2010.03.045

M3 - Article

C2 - 20416952

SN - 0161-6420

VL - 117

SP - 1078-1086.e2

JO - Ophthalmology

JF - Ophthalmology

IS - 6

ER -

A prospective randomized trial of intravitreal bevacizumab or laser therapy in the management of diabetic macular edema (BOLT study) 12-month data: report 2

Abstract

Keywords

UN SDGs

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