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Ophthalmology. 2010 Jun;117(6):1064-1077.e35. doi: 10.1016/j.ophtha.2010.02.031. Epub 2010 Apr 28.

Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema.

Collaborators (583)

Elman MJ, Sloan MD, Butcher TM, Starr J, Gore N, Coffey T, Singletary PV, Salfer-Firestone DY, Andreani G, Ketner DJ, Sotirakos P, Cain T, Chalam KV, Grover S, Gupta SK, Singh TM, Keshavamurthy R, Agarwal S, Phillips WW, Sifrit J, Patel MC, Brar VS, Carpentier JR, Maturi RK, Ciulla T, Hrisomalos NF, Bleau LA, Novak CK, Storie M, Steele T, Maple A, Poston JL, Harless A, Friedman SM, Plous OZ, Blackmer KA, Key JS, Sjoblom K, Maldonado J, Walters-Treon S, McKinney A, Gostischa K, Carlton S, Browning DJ, Brown JC, Antoszyk AN, Brooks DR, Price AK, Cowen MK, Helms JV, Ennis SA, Pierce RE, Karow AS, Lail W, Powers ME, McClain D, George RJ, Clark LM, Schlicker KA, Leotaud PA, Vittitow AR, Balasubramaniam UM, Davis LM, McOwen MD, Ballard JA, Lauer AK, Francis PJ, Bailey ST, Hwang TS, Flaxel CJ, Pope SI, Toomey MD, Nolte SK, Ira SD, Liesegang T, Lundquist AD, Schain M, Vahrenwald DR, Howell CS, Rossi JC, Wallace PR, West KL, Steinkamp PN, Rice PB, Pickell SR, Stone TW, Kitchens JW, Wood WJ, Isernhagen RD, Holcomb DM, Cruz JL, Sears CA, VanHoose B, Buck M, Wolfe JL, Van Arsdall J, Heath WR, Slade EA, Blevins ST, Kidd T, McMillan TA, Perkins SL, Anderson NG, Googe JM, Higdon CT, Evans S, Morris CD, Hunt C, Moore M, Johnson MM, Oliver K, Seitz VL, Arnold A, Jacobus M, Whetstone JK, Blais PA, Oelrich SM, Clark WL, Wells JA, Taylor MM, Cahill CP, Gridine MD, McDougal PD, Henry KL, Spivey R, Henderson ML, Tankersley P, Oliver LL, Hickman AB, Michelson JB, Teasley LA, Manjarrez P, Garcia A, Lee C, Suderno G, Keppler J, Yoo P, Paquette P, Daniels SA, Ting TD, Ray SK, Leong CJ, Aguilos MC, Dowell KJ, Marudo GM, Moreci CM, Tejada RJ, Nguyen TH, Teshima-McCormick SM, Schrock A, Combs WM, Hom N, Hughes MD, Hanamoto F, Dhalla MS, Thompson WS, Anagnoste S, Brady-Lopez JA, Fernandez CV, Quinchia E, Mariano J, Sherley CM, Aramayo P, Ritchie ML, McHugh KL, Fernandez BM, Lambert HM, Willis AW, Khawly JA, Diaz-Rohena R, Miller PS, Busch SK, Fredrickson D, Lazarte VN, Davis KL, Morales JA, Chase KJ, Lowd DK, Muniz JE, Schmidt AW, Bhavsar AR, Emerson GG, Emerson MV, Huynh VT, Olson TM, Boll DJ, Yafchak M, Hager CH, Pearson SL, Selders DL, Smith CM, Chan-Tram C, Carli WB, Kells JA, Taylor-Reetz L, Solomon SD, Scott AW, Bressler NM, Do DV, Bressler S, Frey M, West S, Donohue D, Kellner V, Cain D, Graul J, Mc-Donald J, Emmert D, Shah SM, Belt J, Herring C, Fan JT, Suthar MB, Rauser ME, Davidson CL, Santiago G, Rollins KE, Corliss CJ, Quesada CG, Kiernan WH, Obispo RG, Knabb J, Baker CW, Caldwell TM, Martin TR, Palmer MJ, Lambert LF, Williams TR, Travis AB, Darden DD, Berger BB, Chen E, Wong RW, Davis K, Lummus JR, Manhart GJ, Clevenger-Smith TL, Callen N, Gartner MT, Sun JL, Abeyta GL, Ostrander B, Ren Y, Gross JG, Magee MA, Flowers AM, Henry KL, McDowell AS, Fore CM, Lovit HK, Rohrer JC, Bland KK, Paul AM, Mallet CN, Christoff R, Price RL, Gottlieb JL, Blodi BA, Ip MS, Burke KF, Soderling BH, Olson SR, Wealti AM, Somers SF, Dietzman KA, Knutson GE, Krolnik DA, Peterson JC, Novak MA, Coney JM, Miller DG, Singerman LJ, Stone L, McNamara E, Nitzsche TM, Dubois KA, Tanner V, Cunningham TL, Smith-Brewer SK, DuBois JC, Greanoff GA, Sun JK, Aiello LP, Schlossman DK, Shah ST, Arrigg PG, Silva PS, Sharuk GS, Murtha TJ, Stockman ME, Barenholtz JA, Kirby RK, Calderon RM, Cavallerano JD, BuAbbud JC, Weimann ES, Bestourous L, Cavicchi RW, Koplle A, Shami M, Smith SR, Saldivar Y, Pusser P, Meeks A, Garcia NR, Squires L, Tarter CL, Wentlandt TF, Peters MA, Lemley CA, Lee MS, Handelman IL, Dreyer RF, Hobbs S, Brunelle DA, Kopfer M, Raunig W, Durbin G, Daniel H, Logan J, Mallet CN, Wohlsein H, Pieramici DJ, Nasir MA, Castellarin CA, Rabena MD, Smith J, Sterling AL, Hernandez D, Avery K, Basefsky JC, Tramel L, Boyer K, Risard SM, Giust M, Greven CM, Slusher MM, Fish J, Everhart C, Ledbetter FM, Cooke LN, Miller DT, Clark MD, Tyler M, Marcus DM, Singh H, Zapata GR, McAteer MC, Blair D, Leverett KA, Powell C, Hill CM, Overton KY, Coxville JC, Ivey K, Oldag VL, Ghuman TA, Wing G, Walker JP, Raskauskas PA, Sharma AG, Grodin RW, Kiesel C, Frederick JL, Knips E, Ryan C, Peters CY, Banks JM, Dyshanowitz D, Schoeman EC, Hampton RG, Torrisi PF, Rutledge BK, Spalding SC, Grinnell CJ, Manley ML, Kwasniewski LM, Hay PB, Capone LA, Harrison KM, Novack RL, Boyer D, Tabandeh H, Tam A, Mukarram S, Gasparyan T, Gilmour JK, Sanguinet J, Sierra J, Pachman SE, Protacio EG, Kessinger J, Smucker A, Hartnett ME, Meredith TA, Garg S, Houghton OM, Barnhart CJ, N'Dure F, Morck D, Cantrell D, Esquejo RL, Kinyoun JL, Vemulakonda GA, Rath SA, Burrows PK, Ernst PK, Pettingill JA, Clifton BC, Leslie JD, Stephens C, Topping TM, Cleary TA, Freese LA, Williams L, Hurley VM, Zand PP, Corey EA, Stone JL, Howard TN, Ty R, Chong SG, Moses KL, Graham M, Bennett SA, Jones MC, Scott MH, Wiegman PM, Runde MM, Dvorak TR, Humphrey MJ, Tebon BL, Kim JE, Han DP, Weinberg DV, Connor TB, Wirostko W, Stepien KE, Williams VV, Graf J, Packard KL, Rekow S, Alvarez D, Flanders J, Barwick V, Backes DB, Beringer JR, Keller KL, Selchert KJ, Huang SS, Wilker SC, Tang J, Malik A, Carlton K, Clow C, Burke S, Pankhurst G, Harrod MA, Fish GE, Wang RC, Arnwine J, Tarter CL, Sanchez B, Arceneaux S, Aguado H, Cummings K, Gray K, Mackens M, Hendrix BL, Jaramillo D, Brucker AJ, Drossner SG, DuPont JC, Xu W, Devine C, Nyberg W, Weeney L, Berger JM, Mein CE, Chica MA, Kirschbaum L, Riff E, Tadros MF, Weineke CS, Nakoski B, MacCumber MW, Lluen-Nunez K, Droira C, Pleskovich J, Neely KA, Scott IU, Gardner TW, Chobanoff SM, Walter LE, Hershey M, Strong JD, Bennett TJ, Lazarus HS, Bunch DP, Ridge AD, Booth K, Moore J, Trimble M, Kuppermann BD, Grijalva J, Magallon R, Trump B, Cummings HL, Long DJ, Vermillion JJ, Carpenter S, Berry JP, Gentile RC, Ponce EA, Ou A, Guerrero P, Guerrero C, Gallardo JM, Perez V, Tai KW, Paa JA, Jampol D, Masini R, Whitten P, Carrasquillo-Boyd W, Boyd K, Chan CK, Salib DM, Lin SG, Nuthi AS, Walther KS, Aldana I, Dickerson ED, Myers LE, Warren S, Castillo SU, Huff KM, Chesbrough DJ, Blair M, Lim JI, Niec M, Johnson T, Ovando Y, Janowicz M, Carroll C, Braverman JM, Ciardella AP, Quiroz-Mercado H, Ryman LS, Rhodes RC, Montalvo SI, Harloff SR, Brown DM, Kaufman SR, Estafanous MF, Huff KA, Lamancusa AE, Fill R, Peace M, Williams DM, Pollack JS, MacCumber MM, Ciscato BJ, Lluen-Nune K, Kosinski BM, Droira C, Muir DW, Pleskovich J, Chace R, Kallay S, Dolbec N, Stevens K, Baker-Hill R, Halbmaier J, Smith CW, Woodcome HA, Rego E, DuCoty CL, Varadian S, Salinas C, Banalewicz E, Nagle AL, Hamel M.

Abstract

OBJECTIVE:

Evaluate intravitreal 0.5 mg ranibizumab or 4 mg triamcinolone combined with focal/grid laser compared with focal/grid laser alone for treatment of diabetic macular edema (DME).

DESIGN:

Multicenter, randomized clinical trial.

PARTICIPANTS:

A total of 854 study eyes of 691 participants with visual acuity (approximate Snellen equivalent) of 20/32 to 20/320 and DME involving the fovea.

METHODS:

Eyes were randomized to sham injection + prompt laser (n=293), 0.5 mg ranibizumab + prompt laser (n=187), 0.5 mg ranibizumab + deferred (> or =24 weeks) laser (n=188), or 4 mg triamcinolone + prompt laser (n=186). Retreatment followed an algorithm facilitated by a web-based, real-time data-entry system.

MAIN OUTCOME MEASURES:

Best-corrected visual acuity and safety at 1 year.

RESULTS:

The 1-year mean change (+/-standard deviation) in the visual acuity letter score from baseline was significantly greater in the ranibizumab + prompt laser group (+9+/-11, P<0.001) and ranibizumab + deferred laser group (+9+/-12, P<0.001) but not in the triamcinolone + prompt laser group (+4+/-13, P=0.31) compared with the sham + prompt laser group (+3+/-13). Reduction in mean central subfield thickness in the triamcinolone + prompt laser group was similar to both ranibizumab groups and greater than in the sham + prompt laser group. In the subset of pseudophakic eyes at baseline (n=273), visual acuity improvement in the triamcinolone + prompt laser group appeared comparable to that in the ranibizumab groups. No systemic events attributable to study treatment were apparent. Three eyes (0.8%) had injection-related endophthalmitis in the ranibizumab groups, whereas elevated intraocular pressure and cataract surgery were more frequent in the triamcinolone + prompt laser group. Two-year visual acuity outcomes were similar to 1-year outcomes.

CONCLUSIONS:

Intravitreal ranibizumab with prompt or deferred laser is more effective through at least 1 year compared with prompt laser alone for the treatment of DME involving the central macula. Ranibizumab as applied in this study, although uncommonly associated with endophthalmitis, should be considered for patients with DME and characteristics similar to those in this clinical trial. In pseudophakic eyes, intravitreal triamcinolone + prompt laser seems more effective than laser alone but frequently increases the risk of intraocular pressure elevation.

PMID:
20427088
PMCID:
PMC2937272
DOI:
10.1016/j.ophtha.2010.02.031
[Indexed for MEDLINE]
Free PMC Article
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