A prospective randomized trial of intravitreal bevacizumab or laser therapy in
the management of diabetic macular edema (BOLT study) 12-month data: report 2.
Author(s): 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.
Affiliation(s): Department of Medical Retina, Moorfields Eye Hospital, London, United Kingdom.
michel.michaelides@ucl.ac.uk
Publication date & source: 2010, Ophthalmology. , 117(6):1078-1086
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.
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