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

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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 languageEnglish
Pages (from-to)1078-1086.e2
JournalOphthalmology
Volume117
Issue number6
DOIs
Publication statusPublished - 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

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  • Cite this

    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