Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE study): A 12-month, randomized, controlled, double-masked, multicenter phase II study

Diabetes Care

Volumn 33, Issue 11, 2010, Pages 2399-2405

  Massin, Pascale ^a   Bandello, Francesco ^b   Garweg, Justus G ^c   Hansen, Lutz L ^d   Harding, Simon P ^e   Larsen, Michael ^f   Mitchell, Paul ^g   Sharp, Dianne ^h   Wolf Schnurrbusch, U E K ^c   Gekkieva, Margarita ⁱ   Weichselberger, Andreas ⁱ   Wolf, Sebastian ^c  

^a HÔPITAL LARIBOISIÈRE   (France)

^b UNIVERSITY OF UDINE   (Italy)

^c UNIVERSITY OF BERN   (Switzerland)

^d UNIVERSITY OF FREIBURG   (Germany)

^e UNIVERSITY OF LIVERPOOL   (United Kingdom)

^f UNIVERSITY OF COPENHAGEN   (Denmark)

^g UNIVERSITY OF SYDNEY   (Australia)

^h UNIVERSITY OF AUCKLAND   (New Zealand)

ⁱ NOVARTIS PHARMA AG   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

HEMOGLOBIN A1C; RANIBIZUMAB;

ADULT; ANGINA PECTORIS; ARTERY THROMBOEMBOLISM; ARTICLE; BLADDER CANCER; BLEEDING; CELLULITIS; CENTRAL RETINA THICKNESS; CLINICAL PROTOCOL; CLINICAL STUDY; CONJUNCTIVAL HEMORRHAGE; CONTROLLED CLINICAL TRIAL; DIABETIC GANGRENE; DIABETIC MACULAR EDEMA; DRUG EFFICACY; DRUG INJECTION VOLUME; DRUG SAFETY; EARLY TREATMENT DIABETIC RETINOPATHY STUDY; ENDOPHTHALMITIS; EPIDERMOID CYST; EYE PAIN; GANGRENE; GASTROENTERITIS; HEART INFARCTION; HUMAN; HYPERTENSION; INFECTION; INFESTATION; INSULIN DEPENDENT DIABETES MELLITUS; LASER COAGULATION; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; NONOCULAR HEMORRHAGE; RANDOMIZED CONTROLLED TRIAL; RETINA ARTERY OCCLUSION; RETINA DETACHMENT; RETINA FOVEA; RETINA ISCHEMIA; RHINOPHARYNGITIS; SHAM PROCEDURE; THICKNESS; THROMBOEMBOLISM; TRANSIENT ISCHEMIC ATTACK; TREATMENT DURATION; TREATMENT OUTCOME; VIRAL GASTROENTERITIS; VISUAL ACUITY; VITREOUS HEMORRHAGE;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; DIABETIC RETINOPATHY; FEMALE; HUMANS; MACULAR EDEMA; MALE; MIDDLE AGED; TREATMENT OUTCOME;

EID: 79251606719     PISSN: 01495992     EISSN: 19355548     Source Type: Journal    
DOI: 10.2337/dc10-0493     Document Type: Article

References (25)

1. Diabetes. Fact sheet No. 312 [article online], 2009. Available from http://www.who.int/mediacentre/factsheets/fs312/en/. Accessed 20 December 2009
2. Resnikoff S, Pascolini D, Etya'ale D, Kocur I, Pararajasegaram R, Pokharel GP, Mariotti SP. Global data on visual impairment in the year 2002. Bull World Health Organ 2004;82:844-851
3. Klein R, Klein BE, Moss SE, Cruickshanks KJ. The Wisconsin Epidemiologic Study of Diabetic Retinopathy: XVII. The 14-year incidence and progression of diabetic retinopathy and associated risk factors in type 1 diabetes. Ophthalmology 1998;105:1801-1815
4. King H, Aubert RE, Herman WH. Global burden of diabetes, 1995-2025: prevalence, numerical estimates, and projections. Diabetes Care 1998;21:1414-1431
5. Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch Ophthalmol 1985;103:1796-806
6. Diabetic Retinopathy Clinical Research Network. A randomized trial comparing intravitreal triamcinolone acetonide and focal/grid photocoagulation for diabetic macular edema. Ophthalmology 2008;115:1447-1449, 1449.e1-10
7. Cekiç O, Chang S, Tseng JJ, Akar Y, Barile GR, Schiff WM. Cataract progression after intravitreal triamcinolone injection. Am J Ophthalmol 2005;139:993-998
8. Thomas D, Bunce C, Moorman C, Laidlaw DA. A randomised controlled feasibility trial of vitrectomy versus laser for diabetic macular oedema. Br J Ophthalmol 2005;89:81-86 (Pubitemid 40040244)
9. Aiello LP, Bursell SE, Clermont A, Duh E, Ishii H, Takagi C, Mori F, Ciulla TA, Ways K, Jirousek M, Smith LE, King GL. Vascular endothelial growth factor-induced retinal permeability is mediated by protein kinase C in vivo and suppressed by an orally effective beta-isoform-selective inhibitor. Diabetes 1997;46:1473-1480 (Pubitemid 27369086)
10. Poulaki V. Hypoxia in the pathogenesis of retinal disease. In Retinal Vascular Disease. Joussen AM, Gardner TW, Kirchhof B, Ryan SJ, Eds. Berlin, Germany, Springer, 2007, p. 121-138
11. Simó R, Hernández C. Intravitreous anti-VEGF for diabetic retinopathy: hopes and fears for a new therapeutic strategy. Diabetologia 2008;51:1574-1580
12. Ferrara N, Damico L, Shams N, Lowman H, Kim R. Development of ranibizumab, an anti-vascular endothelial growth factor antigen binding fragment, as therapy for neovascular age-related macular degeneration. Retina 2006;26:859-870 (Pubitemid 44547437)
13. Chun DW, Heier JS, Topping TM, Duker JS, Bankert JM. A pilot study of multiple intravitreal injections of ranibizumab in patients with center-involving clinically significant diabetic macular edema. Ophthalmology 2006;113:1706-1712 (Pubitemid 44442451)
14. Nguyen QD, Shah SM, Heier JS, Do DV, Lim J, Boyer D, Abraham P, Campochiaro PA, READ-2 Study Group. Primary end point (six months) results of the Ranibizumab for Edema of the mAcula in diabetes (READ-2) study. Ophthalmology 2009;116:2175-2181.e1
15. Cunningham ET Jr, Adamis AP, Altaweel M, Aiello LP, Bressler NM, D'Amico DJ, Goldbaum M, Guyer DR, Katz B, Patel M, Schwartz SD, Macugen Diabetic Retinopathy Study Group. A phase II randomized double-masked trial of pegaptanib, an anti-vascular endothelial growth factor aptamer, for diabetic macular edema. Ophthalmology 2005;112:1747-1757
16. Arevalo JF, Fromow-Guerra J, Quiroz-Mercado H, Sanchez JG, Wu L, Maia M, Berrocal MH, Solis-Vivanco A, Farah ME. Primary intravitreal bevacizumab (Avastin) for diabetic macular edema: results from the Pan-American Collaborative Retina Study Group at 6-month followup. Ophthalmology 2007;114:743-750 (Pubitemid 46483714)
17. Lam DS, Lai TY, Lee VY, Chan CK, Liu DT, Mohamed S, Li CL. Efficacy of 1.25 mg versus 2.5 mg intravitreal bevacizumab for diabetic macular edema: six-month results of a randomized controlled trial. Retina 2009;29:292-299
18. Soheilian M, Ramezani A, Obudi A, Bijanzadeh B, Salehipour M, Yaseri M, Ahmadieh H, Dehghan MH, Azarmina M, Moradian S, Peyman GA. Randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus macular photocoagulation in diabetic macular edema. Ophthalmology 2009;116:1142-1150
19. Diabetic Retinopathy Clinical Research Network, Scott IU, Edwards AR, Beck RW, Bressler NM, Chan CK, Elman MJ, Friedman SM, Greven CM, Maturi RK, Pieramici DJ, Shami M, Singerman LJ, Stockdale CR. A phase II randomized clinical trial of intravitreal bevacizumab for diabetic macular edema. Ophthalmology 2007;114:1860-1867
20. Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, Sy JP, Schneider S, ANCHOR Study Group. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med 2006;355:1432-1444 (Pubitemid 44511558)
21. Regillo CD, Brown DM, Abraham P, Yue H, Ianchulev T, Schneider S, Shams N. Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER Study year 1. Am J Ophthalmol 2008;145:239-248
22. Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY, MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med 2006;355:1419-1431 (Pubitemid 44511557)
23. Garcia-Arumi J. Safety profile of diabetic macular edema patients treated over 12 months with ranibizumab in the RESOLVE study. Poster presented at the Annual Meeting of the Association for Research in Vision and Ophthalmology, 1-5 May 2010, Fort Lauderdale, FL
24. Lanzetta P, Burian G, Weichselberger A, Hashad Y. Safety profiles of diabetic versus non-diabetic AMD patients in randomized controlled clinical studies with ranibizumab. Poster presented at the Annual Meeting of the Association for Research in Vision and Ophthalmology, 1-5 May 2010, Fort Lauderdale, FL
25. The 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;117:1064-1077.e35