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Ophthalmology. 2010 Jun;117(6):1134-1146.e3. doi: 10.1016/j.ophtha.2010.03.032. Epub 2010 Apr 24.

Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion.

Collaborators (765)

Aaberg TM, Abraham P, Abujamra S, Acton J, Adamczyk-Ludyga A, Adenwalla M, Agahigian DD, Agoas V, Aguilar-Mendoza M, Aisenbrey S, Alam S, Albiani D, Alexandrescu B, Alfaiate MM, Allam S, Almeida HP, Anagnoste S, Anand R, Anderson N, Antoszyk A, Armogan N, Arnold J, Ash D, Atlas WG, Augustin JA, de Avila MP, Awh C, Azzolini C, Babkova B, Bakri SJ, Banach MJ, Bandello F, Barak A, Barile G, Barker D, Barnard T, Bartz-Schmidt KU, Parodi MB, Baumal C, Bedrich P, Beer P, Mattos RB Jr, Bellini L, Benner J, Benson W, Benz M, Berger B, Bergren R, Bharadwaj A, Bhavan S, Bhavsar A, Binder S, Biondi A, Bishop F, Blair N, Blinder K, Blumenkranz M, Bohm A, Boldrey EE, Bornfeld N, Borrillo JL, Boyer D, Bradford R, Bridges W, Brigatti L, Briggs M, Brooks HL Jr, Brown D, Browning A, Browning D, Brunner S, Brunnerova R, Renata JS, Brydak-Godowska J, Buettner H, Burns J, Burrows AF, Busbee B, Butner R, Butter J, Byrnes G, Callahan C, Campochiaro P, Cano-Hildalgo RA, Canziani T, Capone A, Carmichael T, Carnevale K, Casella AM, Casey R, Castanheira-Dinis A, Celis B, Chambers R, Chang S, Chang YH, Chechik D, Chee SP, Chen E, Chen E, Chen JT, Chen JT, Chen SN, Chen S, Cheng B, Chiquet C, Chong K, Chong LP, Chong V, Chou T, Chow V, Chrapek O, Chu T, Chua J, Chun D, Chung HW, Cialdini AP, Ciancas E, Cihelkova I, Cisiecki S, Clark W, Cleary T, Coco R, Codenotti M, Cohen BZ, Cohen JA, Cohen J, Connolly B, Conway B, Cook H, Cooper B, Coors L, Corwin J, Costa JR, Cottrell D, Couvillion S, Craig J, Cruess A, Cupo G, Dabbs T, Danesh S, Davidorf F, Davis J, De Cilla S, De Fazio R, de la Fuente MA, de la Rua ER, De Mattia M, Deen A, Del Priore L, Delyfer MN, Deuter C, Devadason DS, Devenyi R, d'Heurle D, Dickinson J, Doft B, Dooner J, Doubell D, Downie J, Drenser K, Dreyer R, D'Sousa Y, Du T, Duarte L, DuBiner HB, Dubovy S, Dubska Z, Dugel P, Dunn W, Dusova J, Dvorak J, Dyer D, Dziegielewska K, Earl M, Egan C, Eichenbaum D, Eifrig C, Ells A, El-Shabrawi Y, Elsherbiny S, Engel H, Engelbrecht N, Ernest J, Essex R, Eter N, Evans R, Fakadej A, Falcone P, Fan D, Fan JT, Farah ME, Farah S, Feiner L, Feldman RM, Ferencz J, Fernandez Vega Sanz A, Ferreira JL, Figueira J, Fineman M, Fiser I, Fish G, Fish RH, Fishburne B, Fisher SJ, Fitzsimons R, Flaxel C, Fletcher E, Flores-Aguilar M, Florez S, Flynn H, Fogarty S, Folgado A, Foster BS, Fox GM, Frambach D, Fransen S, Fraser-Bell S, Frederick A, Freeman W, Freisberg L, Friedman E, Friedman L, Fucik M, Fuller DG, Gaitan J, Gallemore R, Gallogly P, Garcia Arumi J, Garg S, Garg S, Garretson B, Gastaud P, Gaudric A, Gawrilow P, Gehlbach PL, Geyer O, Ghuman AT, Giansanti F, Gil AL, Gilbert HD, Gillies M, Girmens JF, Giubilato A, Glacet-Bernard A, Glaser D, Glatzer R, Goldstein D, Gomes AM, Gon Yu H, Gonçalves FP, Gonzales C, Googe J, Gopal L, Gordon A, Gous P, Grand M, Grandao Magro PC, Granero Riano M, Grassi M, Green J, Green S, Gregor Z, Gregori N, Grizzard WS, Groenewald C, Gross JG, Gross NE, Gruber A, Grutow G, Guillet E, Gyorgyova D, Haas A, Haas K, Hadden P, Hagemann L, Hainsworth D, Haivala D, Haller J, Halperin L, Hamer P, Hammer M, Han D, Handa JT, Handelman I, Handza J, Harder B, Harding S, Hariprasad SM, Hartley K, Hartman P, Hartnett ME, Harvey P, Hassan T, Headon M, Heier J, Hejsek L, Higgins P, Hillenkamp J, Ho A, Ho T, Holekamp N, Holz E, Holz F, Hooper P, Hopkins JJ, Hoskin-Mott A, Hoskins J, Hrisomalos N, Hsu J, Hubbard B 3rd, Hudson H, Hughes E, Hunt A, Hunyor A, Hwang T, Hwang JF, Ibarra M, Incarnato N, Inhetvin-Hutter C, Introini U, Isaacs T, Islam N, Iyer MN, Jablonski C, Jack RL, Jager R, Jahn C, Jao C, Jehan F, Jonas J, Joseph D, Joshi M, Jost B, Jurklies B, Kaincova I, Kaiser P, Kaiser R, Kalvodova B, Kamppeter B, Kanann NB, Kang K, Katz RS, Kaushal S, Kecik D, Kellaway J, Kelly K, Kelly S, Khan J, Kherani A, Kim R, Kim I, Kim J, Kim JG, Kim N, Kim R, Kim TW, Kingsley R, Klein R, Klemperer I, Kociecki J, Korbasova M, Korda V, Korobelnik JF, Koshy Z, Kostamaa H, Kovach J, Kozak I, Kozousek V, Krasny J, Kreiger A, Krivosic V, Krug JV Jr, Kruger L, Kunimoto D, Kuppermann BD, Kurtz R, Kuznik-Borkowska A, Lai J, Lai W, Lake S, Lalwani G, Lam WC, Lanning RC, Lanzetta P, Lara W, Larrison WI, Lattanzio R, Lavina A, Lavinsky J, Lazzaroni F, Lee E, Lee JY, Lee M, Lee SY, Lee V, Leff S, Lehr J, Lenfesty P, Leonard R, Levine A, Levitan M, Lewis H, Liew S, Lim J, Lim R, Lim R, Lin R, Lip PL, Liu J, Lobes LA, Loose I, Lottenberg CL, Loutchkina D, Lu DW, Lubczynska A, Lujan B, Lyssek-Boron A, Ma C, Ma P, Maberley D, MacCumber M, Madhusudhana KC, Madreperla S, Magee M, Magolan J, Maia Ode O Jr, Maia A, Majji A, Malthieu D, Mango C, Marmor M, Marques L, Martin D, Martinez JA, Massaoutis P, Mathur R, Mattioli S, Maturi RK, Mazur-Michalek I, McAllister I, McCabe F, McCannel CA, McGimpsey S, McHugh JD, McKibbin M, McLean WC Jr, McMillan T, Meireles R, de Melo CS, Menchini U, Meredith T, Merrill P, Mian U, Michels M, Midena E, Mieler WF, Migliavacca L, Miller D, Miller J, Mincey G, Mitchell P, Mizubuti SK, Mohamed S, Mohammed M, Moinfar N, Moisseiev J, Mones J, Montemayor-Lobo R, Montero J, de Moraes NI, Moreira CA Jr, Morely M, Moreno JM, Moron JT, Morrison VL, Morse L, Moshfeghi A, Moshfeghi D, Muccioli C, Munshi V, Murthy RC, Naing T, Nair R, Nascimento J, Nascimento VP, Nawrocka Z, Nawrocki J, Newell C, Newsom R, Nguyen J, Nguyen Q, Nguyen RL, Nichols J, Nilanjana D, Noguchi B, Noorily S, Novack R, Novak M, Novalis G, O'Brien D, Offermann I, Oguido AP, Oh K, Okruszko A, de Oliveira TL, Oliver S, Ong S, Orellana J, Orzalesi N, O'Toole L, Ovando Y, Paccione J, Pach J, Packo K, Packowska MA, Palmer J, Palmer H, Palombi K, Papp A, Paques M, Paranhos A Jr, Park D, Park RI, Park S, Parke D, Pastor Jimeno JC, Patel S, Patra S, Pavan PR, Pearce I, Pecold K, Pedio M, Peh KK, Peh KK, Pelosini L, Pendergast S, Perez BR, Perez-Ortiz DJ, Perkins S, Peters M, Pheasant T, Pilat J, Pilotto E, Piltz-Seymour J, Pirracchio A, Pollack A, Portella E, Pracharova Z, Prati M, Prensky JG, Preston R, Prieto F, Puls S, Purohit AR, Quintao T, Rahhal F, Rahman W, Ramos AR, Ramsey S, Rani A, Rao PK, Rapizzi E, Raskauskas P, Ratiglia R, Ratnakaram R, Rauser ME, Regillo C, Rehak J, Reichel E, Reid DA, Rejmont L, Renaud Rougier MB, Ribon RI, Ricarova R, Rich R, Riley A, Ripandelli G, Rishi E, Rivett K, Rogers A, Romanet JP, Rosa PJ, Rosberger D, Rose S, Rosenfeld P, Ross RR, Rotberg M, Roth CB, Roth D, Rubaltelli D, Rubsamen P, Ruby A, Ruiz Moreno JM, Ruiz R, Russell Gonder J, Russell M, Ryu JW, Sachs H, Sadda S, Safar A, Salinas C, Sall K, Samad A, Samkova K, Sanders J, Sandhu R, Sandhu SS, Sandner D, Sanislo SR, Sartani G, Saviano S, Savy O, Schechter BA, Schenker HI, Schiff W, Schlichtenbrede F, Schneider B, Schneider L, Schneiderman T, Schocket L, Schoenherr, Schoenleber D, Scholl HP, Schreiber J, Schwartz SD, Sears J, Sedlakova J, Seery C, Sell C, Shah G, Shapiro M, Sharma A, Sheidow T, Sheu SJ, Sheu SJ, Sheufele T, Shukla D, Siewec-Proscinska J, Silva E, Singer M, Singer S, Singerman LJ, Singh M, Siow YC, Sipperley JO, Sivaprasad S, Sjaarda R, Snyder W, Sobrin L, Sodi A, Solomon S, Sonkin P, Soubrane G, Gisèle P, Spirn B, Srivastava S, Stannard K, Staurenghi G, Steinmetz R, Stepien K, Stern W, Stevenson OD, Stewart D, Stolba U, Stoller G, Stone C, Stout JT, Stringfellow G, Studnicka J, Suarez-Figueroa M, Sung J, Susini A, Syracuse R, Szaflik J, Szlechter M, Tabandeh H, Tadayoni R, Takahashi WY, Taleb AC, Talks SJ, Tamayo L, Tan M, Taney B, Tarnawska D, Tassinari G, Taylor J, Telander D, Telander D, Territo C, Thomas M, Thompson JT, Thompson WS, Tiedeman JS, Topping T, Trese M, Truong S, Tsang CW, Tufail T, Ufret-Vincenty R, Uhmannova R, Ulanski L 2nd, Ulinska M, Urminsky J, Uy H, Vaishnav H, Varano M, Vavvas D, Vega Sanz BF, Veloso A, Vicha I, Viola F, Visser L, Vlkova E, Voelker M, Volkert D, Vossmerbaumer U, Vu C, Vyas S, Walker J, Walter A, Andreas R, Wasiak K, Watt DR, Weger M, Weidman F 3rd, Weinberger D, Weisz JM, Wells J 3rd, Wheatley M, Wickremasingh S, Wiegand T, Wieland M, Will D, Williams G, Williams RG, Wilson D, Win PH, Wing GL, Wirostko W, Wirthlin R, Wong AL, Wong T, Wong T, Woo J, Wu TT, Wylegala E, Yan J, Yang CH, Yang CM, Yang Y, Yang YC, Yarian D, Yates P, Yedavally S, Yoken J, Young L, Young S, Zago RJ, Zakov Z, Zaras M, Zegarra H, Ziemianski M, Zimmer-Galler I, Zourdani A, Zur C.

Abstract

OBJECTIVE:

To evaluate the safety and efficacy of dexamethasone intravitreal implant (DEX implant; OZURDEX, Allergan, Inc., Irvine, CA) compared with sham in eyes with vision loss due to macular edema (ME) associated with branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).

DESIGN:

Two identical, multicenter, masked, randomized, 6-month, sham-controlled clinical trials (each of which included patients with BRVO and patients with CRVO).

PARTICIPANTS:

A total of 1267 patients with vision loss due to ME associated with BRVO or CRVO.

INTERVENTION:

A single treatment with DEX implant 0.7 mg (n = 427), DEX implant 0.35 mg (n = 414), or sham (n = 426).

MAIN OUTCOME MEASURES:

The primary outcome measure for the pooled data from the 2 studies was time to achieve a > or =15-letter improvement in best-corrected visual acuity (BCVA). Secondary end points included BCVA, central retinal thickness, and safety.

RESULTS:

After a single administration, the time to achieve a > or =15-letter improvement in BCVA was significantly less in both DEX implant groups compared with sham (P<0.001). The percentage of eyes with a > or =15-letter improvement in BCVA was significantly higher in both DEX implant groups compared with sham at days 30 to 90 (P<0.001). The percentage of eyes with a > or =15-letter loss in BCVA was significantly lower in the DEX implant 0.7-mg group compared with sham at all follow-up visits (P< or =0.036). Improvement in mean BCVA was greater in both DEX implant groups compared with sham at all follow-up visits (P< or =0.006). Improvements in BCVA with DEX implant were seen in patients with BRVO and patients with CRVO, although the patterns of response differed. The percentage of DEX implant-treated eyes with intraocular pressure (IOP) of > or =25 mmHg peaked at 16% at day 60 (both doses) and was not different from sham by day 180. There was no significant between-group difference in the occurrence of cataract or cataract surgery.

CONCLUSIONS:

Dexamethasone intravitreal implant can both reduce the risk of vision loss and improve the speed and incidence of visual improvement in eyes with ME secondary to BRVO or CRVO and may be a useful therapeutic option for eyes with these conditions.

Copyright 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

PMID:
20417567
[PubMed - indexed for MEDLINE]
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