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, MD, FRCOphth, 1,2, * Andrew Kaines, FRANZCO, 1, * Robin D. Hamilton, DM, FRCOphth, 1 Samantha Fraser-Bell, PhD, FRANZCO, 1 Ranjan Rajendram, MD, MRCOphth, 1,2 Fahd Quhill, FRCOphth, 1 Christopher J. Boos, MRCP, MD, 3 Wen Xing, BSc, 4 Catherine Egan, FRANZCO, 1 Tunde Peto, MD, PhD, 1,5 Catey Bunce, DSc, 4 R. David Leslie, MD, FRCP, 6 Philip G. Hykin, MD, FRCOphth 1 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 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 m (range 281–900 m) at baseline to 378134 m (range 167– 699 m) (P0.001) in the ivB group, whereas it decreased to a lesser extent in the laser group, from 481121 m (range 279 – 844 m) to 413135 m (range 170 –708 m) (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. Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article. Ophthalmology 2010;117:1078 –1086 © 2010 by the American Academy of Ophthalmology. Diabetic maculopathy is responsible for the majority of visual loss in patients with diabetic retinopathy. 1–4 Strict glycemic and blood pressure (BP) control remain the most effective interventions to date. 5,6 The Early Treatment of Diabetic Retinopathy Study (ETDRS) showed that laser photocoagulation reduced the risk of moderate visual loss in patients with clinically significant macular edema (CSME) by approximately 50% (from 24% to 12%) at 3 years, although visual acuity (VA) improvement was observed in less than 3% of cases (15-letter gain at 3 years). 7 However, this apparent modest level of improvement may largely be due to the fact that the majority of subjects (85%) had good entry vision (20/40), and it may be more meaningful that 40% of those with entry VA 20/40 improved 1 or more lines. 7 Twenty-five years later, macular laser therapy (MLT) remains the standard-of-care treatment for diabetic macular edema (DME), despite studies of other therapeutic op- 1078 © 2010 by the American Academy of Ophthalmology ISSN 0161-6420/10/$–see front matter Published by Elsevier Inc. doi:10.1016/j.ophtha.2010.03.045