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Ophthalmology. 2011 Dec;118(12):2453-60. doi: 10.1016/j.ophtha.2011.05.014. Epub 2011 Jul 20.

Dexamethasone intravitreal implant in patients with macular edema related to branch or central retinal vein occlusion twelve-month study results.

Collaborators (769)

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 Ávila MP, Awh C, Azzolini C, Babkova B, Bakri SJ, Banach MJ, Bandello F, Barak A, Barile G, Barker D, Barnard T, Bartz-Schmidt KU, Battaglia Parodi M, Baumal C, Bedrich P, Beer P, Belfort Mattos Junior R, 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, Bryan 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, Capaccioli K, 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 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, 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, Eid Farah M, 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, Framme C, 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, Arumi JG, Garg S, Garg S, Garretson B, Gastaud P, Gaudric A, Gawrilow P, Gehlbach PL, Geyer O, Ghuman AT, Giansanti F, Luiz Gil A, 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, Cristina P, Magro G, 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, Gupta A, 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, Yong Lee J, Lee M, Young Lee S, 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, Lotery A, 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 Junior Ode O, Maia A, Majji A, Malthieu D, Mango C, Marmor M, Marques L, Martin D, Martinez JA, Massaoutis P, Mathai A, Mathur R, Mattioli S, Maturi RK, Mazur-Michalek I, McAllister I, McCabe F, McCannel CA, McGimpsey S, McHugh JD, McKibbin M, McLean W 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, Katsuki Mizubuti S, 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, Parravano M, Pastor Jimeno JC, Patel S, Patra S, Pavan PR, Pearce I, Pecold K, Pedio M, 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, 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 U, 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, Sheufele T, Shukla D, Siewec-Proscinska J, Silva ER, 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, Soucek P, Spirn B, Srivastava S, Stannard K, Staurenghi G, Steinmetz R, Stepien K, Stern W, Stevenson OD, Stewart D, Stewart J, Stolba U, Stoller G, Stone C, Stout JT, Stringfellow G, Studnicka J, Suarez-Figueroa M, Sung J, Susini A, Syracuse R, Szaflik J, Tabandeh H, Tadayoni R, Takahashi WY, Taleb AC, Talks SJ, Tamayo L, Tan M, Taney B, Tarnawska D, Tassinari G, Taylor J, Telander D, Territo C, Thomas EL, Thomas M, Thompson JT, Thompson WS, Tiedeman JS, Topping T, Trese M, Truong S, Tsang CW, Tufail A, 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, Wald KJ, Walker J, Walter A, Wang 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 R, 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 1 or 2 treatments with dexamethasone intravitreal implant (DEX implant) over 12 months in eyes with macular edema owing to branch or central retinal vein occlusion (BRVO or CRVO).

DESIGN:

Two identical, multicenter, prospective studies included a randomized, 6-month, double-masked, sham-controlled phase followed by a 6-month open-label extension.

PARTICIPANTS:

We included 1256 patients with vision loss owing to macular edema associated with BRVO or CRVO.

METHODS:

At baseline, patients received DEX implant 0.7 mg (n = 421), DEX implant 0.35 mg (n = 412), or sham (n = 423) in the study eye. At day 180, patients could receive DEX implant 0.7 mg if best-corrected visual acuity (BCVA) was <84 letters or retinal thickness was >250 μm.

MAIN OUTCOME MEASURES:

The primary outcome for the open-label extension was safety; BCVA was also evaluated.

RESULTS:

At day 180, 997 patients received open-label DEX implant. Except for cataract, the incidence of ocular adverse events was similar in patients who received their first or second DEX implant. Over 12 months, cataract progression occurred in 90 of 302 phakic eyes (29.8%) that received 2 DEX implant 0.7 mg injections versus 5 of 88 sham-treated phakic eyes (5.7%); cataract surgery was performed in 4 of 302 (1.3%) and 1 of 88 (1.1%) eyes, respectively. In the group receiving two 0.7-mg DEX implants (n = 341), a ≥ 10-mmHg intraocular pressure (IOP) increase from baseline was observed in (12.6% after the first treatment, and 15.4% after the second). The IOP increases were usually transient and controlled with medication or observation; an additional 10.3% of patients initiated IOP-lowering medications after the second treatment. A ≥ 15-letter improvement in BCVA from baseline was achieved by 30% and 32% of patients 60 days after the first and second DEX implant, respectively.

CONCLUSIONS:

Among patients with macular edema owing to BRVO or CRVO, single and repeated treatment with DEX implant had a favorable safety profile over 12 months. In patients who qualified for and received 2 DEX implant injections, the efficacy and safety of the 2 implants were similar with the exception of cataract progression.

FINANCIAL DISCLOSURE(S):

Proprietary or commercial disclosure may be found after the references.

Comment in

PMID:
21764136
DOI:
10.1016/j.ophtha.2011.05.014
[Indexed for MEDLINE]

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