A 2-year prospective randomized controlled trial of intravitreal bevacizumab or laser therapy (BOLT) in the management of diabetic macular edema: 24-Month data: Report 3

Archives of Ophthalmology

Volumn 130, Issue 8, 2012, Pages 972-979

  Rajendram, Ranjan ^a,b   Fraser Bell, Samantha ^a,c   Kaines, Andrew ^a   Michaelides, Michel ^a,b   Hamilton, Robin D ^a   Esposti, Simona Degli ^a   Peto, Tunde ^a   Egan, Catherine ^a   Bunce, Catey ^a   Leslie, Richard David ^d   Hykin, Philip G ^a  

^a MOORFIELDS EYE HOSPITAL   (United Kingdom)

^b UNIVERSITY COLLEGE LONDON   (United Kingdom)

^c UNIVERSITY OF SYDNEY   (Australia)

^d QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; EYE DROPS; LUBRICATING AGENT;

ANEMIA; ANGINA PECTORIS; ARGON LASER; ARTICLE; BELL PALSY; BEST CORRECTED VISUAL ACUITY; BLURRED VISION; CENTRAL MACULAR THICKNESS; CEREBROVASCULAR ACCIDENT; CHEST INFECTION; CONJUNCTIVAL HEMORRHAGE; CONSCIOUSNESS DISORDER; CONTROLLED STUDY; CORNEA DISEASE; CORNEA EPITHELIUM DEFECT; CORONARY ARTERY DISEASE; DIABETIC FOOT; DIABETIC MACULAR EDEMA; DISEASE SEVERITY; DIZZINESS; DYSPNEA; ELECTROCARDIOGRAPHY; ENDOPHTHALMITIS; EPIPHORA; EYE DISEASE; EYE INFLAMMATION; EYE IRRITATION; EYE PAIN; EYE REDNESS; FALLING; FATIGUE; FLOATER; GASTROENTERITIS; GLARE; HEADACHE; HUMAN; HYPERTENSION; INFUSION RELATED REACTION; INTERMETHOD COMPARISON; INTERMITTENT CLAUDICATION; INTRAOCULAR HYPERTENSION; INTRAOCULAR PRESSURE; LOW LEVEL LASER THERAPY; MAJOR CLINICAL STUDY; OUTCOME ASSESSMENT; PATIENT SAFETY; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RED EYE; RETINA DETACHMENT; RETINA DISEASE; RETINA FLUORESCEIN ANGIOGRAPHY; RETINA MACULA EDEMA; RHEUMATIC POLYMYALGIA; SIDE EFFECT; THORAX PAIN; URINARY TRACT INFECTION; VISUAL ACUITY; VISUAL IMPAIRMENT; VISUAL SYSTEM PARAMETERS; VITRECTOMY; VITREOMACULAR TRACTION; VITREOUS HEMORRHAGE; VOMITING;

ADULT; AGED; ANGIOGENESIS INHIBITORS; ANTIBODIES, MONOCLONAL, HUMANIZED; DIABETIC RETINOPATHY; DOUBLE-BLIND METHOD; FEMALE; FLUORESCEIN ANGIOGRAPHY; HUMANS; INTRAVITREAL INJECTIONS; LASER COAGULATION; MACULAR EDEMA; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; RETREATMENT; TIME FACTORS; TOMOGRAPHY, OPTICAL COHERENCE; TREATMENT OUTCOME; VASCULAR ENDOTHELIAL GROWTH FACTOR A; VISUAL ACUITY;

EID: 84865593623     PISSN: 00039950     EISSN: 15383601     Source Type: Journal    
DOI: 10.1001/archophthalmol.2012.393     Document Type: Article

References (25)

1. Early Treatment Diabetic Retinopathy Study Research Group. Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Arch Ophthalmol. 1985;103(12):1796-1806.
2. Michaelides M, Kaines A, Hamilton RD, et al. 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. 2010;117 (6):1078-1086, e2.
3. Michaelides M, Fraser-Bell S, Hamilton R, et al. Macular perfusion determined by fundus fluorescein angiography at the 4-month time point in a prospective randomized trial of intravitreal bevacizumab or laser therapy in the management of diabetic macular edema (BOLT Study): report 1. Retina. 2010;30(5):781-786.
4. Bandello F, De Benedetto U, Knutsson KA, Parodi MB, Cascavilla ML, Iacono P. Ranibizumab in the treatment of patients with visual impairment due to diabetic macular edema. Clin Ophthalmol. 2011;5:1303-1308.
5. Krohne TU, Eter N, Holz FG, Meyer CH. Intraocular pharmacokinetics of bevacizumab after a single intravitreal injection in humans. Am J Ophthalmol. 2008; 146(4):508-512.
6. Miyake T, Sawada O, Kakinoki M, et al. Pharmacokinetics of bevacizumab and its effect on vascular endothelial growth factor after intravitreal injection of bevacizumab in macaque eyes. Invest Ophthalmol Vis Sci. 2010;51(3):1606-1608.
7. Sharma RK, Rogojina AT, Chalam KV. Bevacizumab therapy normalizes the pathological intraocular environment beyond neutralizing VEGF. Mol Vis. 2010;16: 2175-2184.
8. Funatsu H, NomaH,Mimura T, Eguchi S, Hori S. Association of vitreous inflammatory factors with diabetic macular edema. Ophthalmology. 2009;116(1):73-79.
9. Arevalo JF, Sanchez JG, Fromow-Guerra J, et al Pan-American Collaborative Retina Study Group (PACORES). Comparison of two doses of primary intravitreal bevacizumab (Avastin) for diffuse diabetic macular edema: results from the Pan- American Collaborative Retina Study Group (PACORES) at 12-month follow-up. Graefes Arch Clin Exp Ophthalmol. 2009;247(6):735-743.
10. Soheilian M, Ramezani A, Obudi A, et al. Randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus macular photocoagulation in diabetic macular edema. Ophthalmology. 2009;116(6):1142- 1150.
11. Goyal S, LavalleyM, Subramanian ML. Meta-analysis and review on the effect of bevacizumab in diabetic macular edema. Graefes Arch Clin Exp Ophthalmol. 2011; 249(1):15-27.
12. Massin P, Bandello F, Garweg JG, et al. Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE Study): a 12-month, randomized, controlled, double-masked, multicenter phase II study. Diabetes Care . 2010;33 (11):2399-2405.
13. Mitchell P, Bandello F, Schmidt-Erfurth U, et al; RESTORE study group. The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology. 2011;118(4):615- 625.
14. ElmanMJ, Aiello LP, Beck RW, et al; Diabetic Retinopathy Clinical Research Network. Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology. 2010; 117(6):1064-1077, e35.
15. van der ReisMI, La Heij EC, De Jong-Hesse Y, Ringens PJ, Hendrikse F, Schouten JS. A systematic review of the adverse events of intravitreal anti-vascular endothelial growth factor injections. Retina. 2011;31(8):1449- 1469.
16. Martin DF, Maguire MG, Ying GS, Grunwald JE, Fine SL, Jaffe GJ; CATT Research Group. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med. 2011;364(20):1897-1908.
17. Curtis LH, Hammill BG, Schulman KA, Cousins SW. Risks of mortality, myocardial infarction, bleeding, and stroke associated with therapies for age-related macular degeneration. Arch Ophthalmol. 2010;128(10):1273-1279.
18. Zhang X, Saaddine JB, Chou CF, et al. Prevalence of diabetic retinopathy in the United States, 2005-2008. JAMA. 2010;304(6):649-656.
19. van Dieren S, Beulens JW, van der Schouw YT, Grobbee DE, Neal B. The global burden of diabetes and its complications: an emerging pandemic. Eur J Cardiovasc Prev Rehabil. 2010;17(suppl 1):S3-S8.
20. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993; 329(14):977-986.
21. White NH, Sun W, Cleary PA, et al DCCT-EDIC Research Group. Effect of prior intensive therapy in type 1 diabetes on 10-year progression of retinopathy in the DCCT/ EDIC: comparison of adults and adolescents. Diabetes. 2010;59(5):1244-1253.
22. UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ. 1998;317(7160):703-713.
23. Dolgin E. In vision trial, some researchers would rather see double. Nat Med. 2010;16(6):611.
24. Beck RW, Edwards AR, Aiello LP, et al Diabetic Retinopathy Clinical Research Network (DRCR.net). Three-year follow-up of a randomized trial comparing focal/ grid photocoagulation and intravitreal triamcinolone for diabetic macular edema. Arch Ophthalmol. 2009;127(3):245-251.
25. Schachat AP. A new approach to the management of diabetic macular edema. Ophthalmology. 2010;117(6):1059-1060.