A 12-Month, Single-Masked, Randomized Controlled Study of Eyes with Persistent Diabetic Macular Edema after Multiple Anti-Vegf Injections to Assess the Efficacy of the Dexamethasone-Delayed Delivery System as an Adjunct to Bevacizumab Compared with Continued Bevacizumab Monotherapy

Retina

Volumn 35, Issue 8, 2015, Pages 1604-1614

  Maturi, Raj K ^a,b   Bleau, Laura ^a   Saunders, Jeffrey ^c   Mubasher, Mohamed ^c   Stewart, Michael W ^d  

^a MIDWEST EYE INSTITUTE   (United States)

^b INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c JAEB CENTER FOR HEALTH RESEARCH   (United States)

^d MAYO CLINIC   (United States)

Author keywords

bevacizumab; dexamethasone; diabetic macular edema; sustained release implant; vascular endothelial growth factor

Indexed keywords

BEVACIZUMAB; BRIMONIDINE PLUS TIMOLOL; DEXAMETHASONE; ANGIOGENESIS INHIBITOR; DRUG IMPLANT; GLUCOCORTICOID; VASCULOTROPIN A; VEGFA PROTEIN, HUMAN;

ABRASION; ADULT; ARTICLE; CATARACT; CENTRAL RETINAL THICKNESS; CLINICAL ARTICLE; COMPARATIVE STUDY; CONJUNCTIVAL HEMORRHAGE; CONTROLLED STUDY; CORTICOSTEROID THERAPY; DIABETIC MACULAR EDEMA; DISEASE COURSE; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG SAFETY; FEMALE; FOLLOW UP; HUMAN; INJECTION; INSULIN DEPENDENT DIABETES MELLITUS; INTRAOCULAR PRESSURE ABNORMALITY; INTRAVITREAL IMPLANT; LENS IMPLANT; MACULAR THICKNESS; MALE; MONOTHERAPY; NON INSULIN DEPENDENT DIABETES MELLITUS; OPTICAL COHERENCE TOMOGRAPHY; PROSPECTIVE STUDY; PUNCTATE KERATITIS; RANDOMIZED CONTROLLED TRIAL; THERAPY DELAY; TREATMENT RESPONSE; VISUAL ACUITY; VITREOUS FLOATERS; AGED; ANTAGONISTS AND INHIBITORS; COMPLICATION; DIABETIC RETINOPATHY; DRUG COMBINATION; DRUG IMPLANT; INTRAVITREAL DRUG ADMINISTRATION; MACULAR EDEMA; MIDDLE AGED; PATHOPHYSIOLOGY; PHYSIOLOGY; SINGLE BLIND PROCEDURE; TREATMENT OUTCOME; VITREOUS BODY;

AGED; ANGIOGENESIS INHIBITORS; BEVACIZUMAB; DEXAMETHASONE; DIABETES MELLITUS, TYPE 1; DIABETES MELLITUS, TYPE 2; DIABETIC RETINOPATHY; DRUG IMPLANTS; DRUG THERAPY, COMBINATION; FEMALE; FOLLOW-UP STUDIES; GLUCOCORTICOIDS; HUMANS; INTRAVITREAL INJECTIONS; MACULAR EDEMA; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; SINGLE-BLIND METHOD; TOMOGRAPHY, OPTICAL COHERENCE; TREATMENT OUTCOME; VASCULAR ENDOTHELIAL GROWTH FACTOR A; VISUAL ACUITY; VITREOUS BODY;

EID: 84938810401     PISSN: 0275004X     EISSN: 15392864     Source Type: Journal    
DOI: 10.1097/IAE.0000000000000533     Document Type: Article

References (34)

1. Early Treatment Diabetic Retinopathy Study research group. Photocoagulation for diabetic macular edema: Early Treatment Diabetic Retinopathy Study report number 1. Arch Ophthalmol 1985;103:1796-1806.
2. Elman MJ, Bressler NM, Qin H, et al. Expanded 2-year follow-up of ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology 2011;118:609-614.
3. Elman MJ, Aiello LP, Beck RW, et al; Diabetic Retinopathy Clinical Research Network. Randomized trial evaluating rani-bizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology 2010;117:1064-1077.
4. Nguyen QD, Brown DM, Marcus DM, et al; RISE and RIDE Research Group. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology 2012;119:789-801.
5. Do DV, Nguyen QD, Boyer D, et al; DA VINCI Study Group. One-year outcomes of the DA VINCI Study of VEGF Trap-Eye in eyes with diabetic macular edema. Ophthalmology 2011;118:1819-1826.
6. Stewart MW. The expanding role of vascular endothelial growth factor inhibitors in ophthalmology. Mayo Clin Proc 2012;87:77-88.
7. Nguyen QD, Shah SM, Van Anden E, et al. Supplemental oxygen improves diabetic macular edema: a pilot study. Invest Ophthalmol Vis Sci 2004;45:617-624.
8. Wilson CA, Berkowitz BA, Sato Y, et al. Treatment with intra-vitreal steroid reduces bloodretinal barrier breakdown due to retinal photocoagulation. Arch Ophthalmol 1992;110:1155-1159.
9. Sohn HJ, Han DH, Kim IT, et al. Changes in aqueous concentrations of various cytokines after intravitreal triamcinolone versus bevacizumab for diabetic macular edema. Am J Oph-thalmol 2011;152:686-694.
10. Campochiaro PA, Brown DM, Pearson A, et al. Long-term benefit of sustained-delivery fluocinolone acetonide vitreous inserts for diabetic macular edema. Ophthalmology 2011; 118:626-635.
11. Tas M, Oner V, Alakus MF, et al. Single injection of triam-cinolone versus three repeated injections of bevacizumab for treatment of diabetic macular edema. Int Ophthalmol 2013;33: 375-380.
12. Chan CK, Mohamed S, Lee VY, et al. Intravitreal dexameth-asone for diabetic macular edema: a pilot study. Ophthalmic Surg Lasers Imaging 2010;40:26-30.
13. Gan IM, Ugahary LC, van Dissel JT, et al. Effect of intravitreal dexamethasone on vitreous vancomycin concentrations in patients with suspected postoperative bacterial endophthalmitis. Graefes Arch Clin Exp Ophthalmol 2005;243:1186-1189.
14. Chang-Lin JE, Attar M, Acheampong AA, et al. Pharmacoki-netics and pharmacodynamics of a sustained-release dexameth-asone intravitreal implant. Invest Ophthalmol Vis Sci 2011;52: 80-86.
15. Sohelian M, Garfami KH, Ramezani A, et al. Two-year results of a randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus laser in diabetic macular edema. Retina 2012;32:314-321.
16. Synek S, Veselý P. Intravitreal bevacizumab with or without triamcinolone for refractory diabetic macular oedema. Coll Antropol 2011;35:841-845.
17. Lim JW, Lee HK, Shin MC. Comparison of intravitreal bev-acizumab alone or combined with triamcinolone versus triam-cinolone in diabetic macular edema: a randomized clinical trial. Ophthalmologica 2012;227:100-106.
18. Marey HM, Ellakwa AF. Intravitreal bevacizumab alone or combined with triamcinolone acetonide as the primary treatment for diabetic macular edema. Clin Ophthalmol 2011;5:1011-1016.
19. Soheilean 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;116:1142-1150.
20. Faghihi H, Roohipoor R, Mohammadi SF, et al. Intravitreal bevacizumab versus combined bevacizumab-triamcinolone versus macular laser photocoagulation in diabetic macular edema. Eur J Ophthalmol 2008;18:941-948.
21. Ahmadieh H, Ramezani A, Shoeibi N, et al. Intravitreal bev-acizumab with or without triamcinolone for refractory diabetic macular edema: a placebo-controlled, randomized clinical trial. Graefes Arch Clin Exp Ophthalmol 2008;246:483-489.
22. Kupperman BD, Blumenkranz MS, Haller JA, et al; for the Dexamethasone DDS Phase II Study Group. Randomized controlled study of an intravitreous dexamethasone drug delivery system in patients with persistent macular edema. Arch Oph-thalmol 2007;125:309-317.
23. Boyer DS, Faber D, Gupta S, et al; for the Ozurdex Champlain Study Group. Dexamethasone intravitreal implant for treatment of diabetic macular edema in vitrectomized patients. Retina 2011;31:915-923.
24. Sharma A, Madhusudhan RJ, Nadahalli V, et al. Change in macular thickness in a case of refractory diabetic macular edema with dexamethasone intravitreal implant in comparison to intravitreal bevacizumab: a case report. Ind J Ophthalmol 2012;60:234-235.
25. Rishi P, Rishi E, Kuniyal L, et al. Short-term results of intra-vitreal dexamethasone implant (Ozurdex) in treatment of recalcitrant diabetic macular edema: a case series. Oman J Ophthalmol 2012;5:79-82.
26. Haller JA, Kupperman BD, Blumenkranz MS, et al; for the Dexamethasone DDS Phase II Study Group. Randomized controlled trial of an intravitreous dexamethasone drug delivery system in patients with diabetic macular edema. Arch Ophthal-mol 2010;128:289-296.
27. Zhang Y, Ma J, Meng N, et al. Comparison of intravitreal triamcinolone acetonide with intravitreal bevacizumab for treatment of diabetic macular edema: a meta-analysis. Curr Eye Res 2013;38:578-587.
28. Flaxel CJ, Edward AR, Aiello LP, et al. Factors associated with visual acuity outcomes after vitrectomy for diabetic macular edema: diabetic retinopathy clinical research network. Retina 2010;30:1488-1495.
29. Chhablani JK, Kim JS, Cheng L, et al. External limiting membrane as a predictor of visual improvement in diabetic macular edema after pars plana vitrectomy. Graefes Arch Clin Exp Ophthalmol 2012;250:1415-1420.
30. Uji A, Nishijima K, Akagi T, et al. Association between hyper-reflective foci in the outer retina, status of photoreceptor layer, and visual acuity in diabetic macular edeam. Am J Ophthalmol 2012;153:710-717.
31. Coscas G, Coscas F, Zucchiatti I, et al. SD-OCT pattern of retinal venous occlusion with cystoid macular edema treated with Ozurdex. Eur J Ophthalmol 2011;21:631-636.
32. SCORE Study Research Group. A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with standard care to treat vision loss associated with macular edema secondary to branch retinal vein occlusion: the Standard Care vs. Corticosteroid for Retinal Vein Occlusion (SCORE) Study report 6. Arch Ophthalmol 2009;127: 1115-1128.
33. Boyer DS, Yoon YH, Belfort R Jr., et al; Ozurdex MEAD Study Group. Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology 2014;121:1904-1914.
34. Kiddee W, Trope GE, Sheng L, et al. Intraocular pressure monitoring post intravitreal steroids: a systematic review. Surv Ophthalmol 2013;58:291-310.