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Ophthalmology. 2008 Sep;115(9):1447-9, 1449.e1-10. doi: 10.1016/j.ophtha.2008.06.015. Epub 2008 Jul 26.

A randomized trial comparing intravitreal triamcinolone acetonide and focal/grid photocoagulation for diabetic macular edema.

Collaborators (959)

Elman MJ, Raden RZ, Sloan MD, Butcher TM, Starr J, Salfer-Firestone D, Singletary PV, Coffey T, Gore N, Shabi G, Cain T, Sotirakos P, Stone TW, Wood WJ, Isernhagen RD, Kitchens JW, Heath WR, Holcomb DM, Cruz JL, Van Arsdall J, Buck M, Millett C, Slade EA, Blevins ST, Friedman SM, Plous OZ, Blackmer KA, Key JS, Carlton SD, Sjoblom KL, Fagan DA, Gregory V, Maldonado J, Gostischa KA, McKinney A, Glatzer RJ, Thompson WS, Brady-Lopez JA, Fernandez CV, Tardif AA, Sherley CM, Quinchia E, Birth JA, Bolet A, Benton-Murray J, Aramayo P, Fernandez BM, Earl M, McHugh KL, Hampton GR, Spalding SC, Torrisi PF, Rutledge BK, Grinnell CJ, DiSano FM, Kwasniewski LM, Czajak TC, Hay PB, Burke JL, Fyles KB, Corey B, Capone LA, Browning D, Antoszyk AN, Brooks DR, Cowen MK, Helms JV, Price AK, Murphy HL, Chatari LB, Walker RO, Pierce RE, McClain D, Ruiz KA, Davis LM, Balasubramaniam UM, Lutman B, McOwen MD, George RJ, Clark LM, Pieramici DJ, Castellarin AA, Rabena MD, Smith R, Magana LD, Sterling AL, Norton TA, Davies SK, Robbins EA, Tramel L, Basefsky JC, Avery K, Hernandez D, Kruzel ML, Boyer K, Giust M, Lauer AK, Flaxel CJ, Hwang TS, Pope SI, Hanel SA, Toomey MD, Vahrenwald DR, Nolte SK, Ira SD, Wallace PR, Rice PB, West KL, Redenbo EF, Steinkamp PN, Gaultney JM, Howell CS, Singerman LJ, Novak MA, Miller DG, Nitzsche TM, McNamara E, Schach KL, Weiss DE, Tanner V, Dubois KA, Cunningham TL, Greanoff GA, Smith-Brewer SK, DuBois JC, Gottlieb J, Blodi BA, Altaweel MM, Ip MS, Nork TM, Burke KF, Soderling BH, Perry-Raymond JR, Wealti AM, Soderling ED, Pohlman AJ, Dietzman KA, Somers GF, Olson SR, Peterson JC, Krolnik DA, Knutson GE, Brown DM, Kim RY, Wong TP, Benz MS, Fish RH, Hallett JE, Rodriguez MA, De La Garza R, Hutchinson C, Tang XS, Norris JB, Kubecka D, Hay S, Mutz KA, Kimbrough AD, Williamson A, Kegley EN, Skelly ML, Evans MA, Fan JT, Suthar MB, Rauser ME, Rollins KE, Chakrabarty AK, Quesada CG, Osuna SL, Corliss CJ, Kiernan WH, Ortega AM, Saldana G, Milam W, Cloud JD, Lazarus HS, Bunch DP, Ridge AD, Booth K, Davis LC, Moore J, Trimble M, Smith CW, Woodcome HA, Krzystolik MG, Greenberg PB, Janigian RH, DuCoty CL, Varadian S, Salinas C, Henriques S, Banalewicz E, Hamel M, Nagle AL, Benner JD, Butler JW, Scott H, Hamill K, McCrorey JM, Hurley RL, Welch L, Carbaugh C, Goodwin AE, Richmond PP, Olson JC, Lieb DF, Barnes CD, Shaikh SA, Okun NJ, Bell G, Davila LD, Treutel JA, Huertas C, Diaz CR, Thornton TE, Jarrett R, Patel SS, Lee SY, Garcia KL, Jaimes A, Arrington BK, Dunn BL, Nafe GR, Jones T, Adams LD, Bartlett TA, Hoffert D, Flynn TE, Sutherland D, Wilbur LR, Forni T, Betterley P, Shorey ML, Frazier KA, Novack RL, Boyer DS, Rahhal FM, Mukarram S, Gasparyan T, Sierra J, Sanguinet J, Smucker A, Kessinger J, Sharuk GS, Murtha TJ, Arrigg PG, Sun JK, Kopple A, Stockman ME, Bestourous L, Cavallerano JD, Strong J, Casazza EL, Cavicchi RW, Schlossman DK, Shah ST, Aiello LP, Braverman JM, Ciardella AP, Ryman LS, Stillberger MA, Zapata JD, Montalvo SI, Rhodes RC, Brown DM, Googe J, Anderson NG, Higdon CT, Morris CD, Evans S, Strong TE, Seitz VL, Hunt C, Cimino DJ, Blais PA, Jacobus M, Shami M, Pusser P, Tarter CL, Gutierrez NR, Squires L, Anderson EM, Wentlandt TF, Kingsley RM, Leonard RE, Youngberg MD, Ogilbee LM, Dwiggins CJ, Hart JS, Richmond WR, Burris R, Baker CW, Caldwell TM, Martin TR, Palmer MJ, Lambert LF, Travis AB, Smith DD, Gross JG, Fishburne BC, Magee MA, Flowers AM, Cummings PW, Henry KL, Gabriel RA, Bland KK, Lovit HK, Mallet CN, Price RL, Fish GE, Wang RC, Arnwine J, Sanchez B, Arceneaux S, Hendrix BL, Cummings K, Ellenich P, Jaramillo D, Gray K, Aguado H, Davis GH, Li HK, Spillar H, Seitz VL, Zertuche AD, Nolen RR, Bourg JM, Garcia-Garza GA, Krason Z, Horna J, Crocker A, Kelso C, Aaberg TM, Raphaelian PV, Scott S, Kronlein S, Markus D, Lewis S, Scott IU, Gardner TW, Neely KA, Chobanoff SM, Walter LE, Wilmarth M, Frawley ML, Strong JD, Bennett TJ, Brucker AJ, Stoltz RA, Drossner S, DuPont JC, Boxley SL, McRay M, Devine C, Weeney L, Berger JM, Nyberg W, Aleman TS, Clark WL, Wells JA, Gridine MD, Bearden RT, Cahill CP, McDougal PD, Henderson ML, Hickman AB, Spivey R, Greven CM, Slusher MM, Fish J, Ledbetter FM, Clark MD, Miller DT, Tyler M, Callanan DG, Solley WA, Bradley PJ, Elmore GJ, Grimes CA, Creighton JR, Garcia Y, Boleman B, Gray K, Huang SS, Chattah NM, Karpinecz LL, Buckholz KB, Norell MA, Clow C, Carlton K, Burke S, Harrod MA, Pankhurst G, Benetz BA, Wing G, Raskauskas PA, Ghuman AT, Walker JP, Kiesel C, Knips E, Dyshanowitz D, Banks JM, Garcia CA, Patel K, Foster WJ, McCrary J, Garibay E, Lessieur EM, Martinez O, Banda D, Montoya JP, Vi Nguyen C, Paz HL, Santisbon E, Ramirez A, Cerda SM, Salinas LR, Stoever CA, Livas B, Cummings E, Calderon EE, Pollack JS, Civantos JM, Ciscato BJ, Mikota RA, Kosinski BM, Muir DW, Bhavsar AR, Olson TM, Chan C, Ries J, Carli WB, Pearson SL, Hager CH, Spike-Kivel M, Jodell J, Taylor-Reetz L, Ortiz DJ, Perez BR, Alvarez M, Johnson RL, Montoya SE, Jarrett R, Davidorf FH, Chambers RB, Elliott RJ, Milliron JD, Chaudhuri CG, Perry JG, Halk AC, Savage SJ, Keating MJ, Cummings HL, Couch DA, Gunn JM, Long DJ, Darnell G, Vermillion JJ, Mallard R, Berry JP, Carpenter S, Schwartz SD, Gonzales CR, Gupta A, Ostrick R, Khwarg JW, Rosman ML, Shokouh B, Chun M, Kageyama J, Moral J, Tetreault M, Le Beck DL, Lipka KM, Kim JE, Wirostko WJ, Han DP, Alvarez D, Drescher TS, Lange CY, Reiter KM, Graf J, Flanders J, Barwick V, Selchert KJ, Backes DB, Beringer JR, Daniels SA, Ray SK, Leong CJ, Ting TD, Moreci CM, Takahara S, Dowell KJ, Combs WM, Tejada RJ, Hom N, Williams M, Hughes MD, Hanamoto F, Berger BB, Manhart GJ, Rodriguez M, Durham EA, Jeffers SA, Clevenger-Smith TL, Scrivner EN, Callen N, Talbert MA, Dorn DS, Gallia B, Gartner MT, Ren Y, Ostrander B, Maturi RK, Minturn JT, Bleau LA, Agugliaro D, Storie M, Novak CK, Samaniego DL, Morrow SJ, Maple A, Poston JL, Steele T, Ie D, Lipkowitz JL, Geraghty S, Sannazzaro BR, Harper M, Polanco L, Napoli D, McCall L, Gonzalez VH, Vann VR, Guel DA, McNames RL, Herrera J, Ramirez D, Rodriguez G, Lopez M, Garza G, Martinez MM, Herrera A, Trevino MG, Cuellar D, Garza C, Corona RM, Chan CK, Nuthi AS, Salib DM, Lin SG, Tarasewicz DG, Walther KS, Koch W, Campbell CM, Sage KE, Dickerson ED, Andresen TA, Wiskirchen TB, Keith TL, Warren S, Sandra S, Rollins K, Huff KM, Evans R, Chesbrough DJ, Chen M, Holland C, Hagin K, Miller R, Sneath M, Beer PM, Falk N, Olmeda E, Newton AL, Garza D, Whitney C, Fischer J, Faulhammer LA, Davis R, Feman SS, Akduman L, Anderson JS, Anderson KL, Willerton RJ, Ghadban R, Burke P, Porter TI, Salvalaggio DD, Breeding L, Kleber CJ, Apte RS, Blinder KJ, Engelbrecht NE, Rao PK, Nobel GS, Light PA, Weeks RF, Walters CL, Sgorlon MK, Boyd LK, Vaughn AM, Wright TL, Gabel DL, Raeber ML, Wehmeier J, Solomon SD, Finkelstein D, Bressler S, Frey M, Doll W, Donohue D, Jurao R, Sheehan SE, Shah SM, Cain D, Falk R, Graul J, McDonald J, Herring C, Belt J, Emmert D, MacCumber MW, Merrill PT, Sheth ND, Levine SJ, Voskuil-Marre D, Gaynes BI, Pappas L, Hulvey P, Pleskovich JM, Lyon AT, Mathura JR, Kaminski L, Ackatz L, O'Donnell LM, Rozenbajgier Z, Shankle J, Ryan DM, Simjanoski E, Edwards PA, Ober MD, Rock SM, Monk MK, Murphy J, Wilson DF, Croswell M, Troszak TA, Stern BA, Rusinek BA, Smith AL, Schillace LM, Phillips WB, Berinstein D, Garfinkel R, Kaplan G, Oliver D, Byank LS, Haziminas JC, Kruzel M, Bickhart E, Frantz R, Ayyad A, Flory M, Walker Y, Peters MA, Handelman IL, Ma C, Hobbs S, Reichenberger KJ, Raunig W, Kramer SM, Durbin G, Kopfer M, Logan J, Daniel H, Wohlsein H, Johnson M, Jumper JM, McDonald HR, Fu AD, Rose JM, Fiermonte P, Stolarczuk M, Teske B, Linares SC, Ryan DM, Grout ST, Esquejo RL, Bye AJ, Huggans S, Chen S, You TT, Casiano ME, Agustin EB, Zimmer N, Vazquez A, Topping TM, Heier JS, Morley MG, Williams L, Hurley VM, Tyler LA, Zand PP, Daniel PE, Yenyil HL, Chong SG, Howard TN, Marino K, Graham M, Jones M, Hartnett ME, Landers MB, Meredith TA, Garg S, Barnhart CJ, Vallar CD, Esquejo RL, Shields KD, Cantrell D, Kuppermann BD, Grijalva J, Magallon R, Trump B, Safar A, Kim NM, Hankins SK, Troillett DL, Brown AK, Aletter K, Troillett CJ, Brummett SK, Walsh AC, Lim JI, Flaxel CJ, Chong LP, Padilla M, Garcia JM, Richine LS, Dougall JA, Lansing M, Fox LB, Ross JE, Alexander KA, Smith RK, Roussel DJ, Goodart RA, Faber DW, Mehr DS, Murphy HJ, Perkins TL, Osguthorpe RW, Knight D, Kinyoun JL, Saperstein DA, Rath SA, Pettingill J, Lawrence BS, Ernst PK, Clifton BC, Leslie JD, Stephens C, Kokame GT, Shen J, Yuen A, Klesert TR, Olsen TW, Rath P, Walski JM, Cook S, Rolfer SM, Patterson PK, Philiph D, Cohen MJ, Harvey PS, Recchia FM, Agarwal A, Sternberg P, Owings S, Kinder KM, Franklin CC, Mofield GG, Taylor-Ward MB, Munn GE, Recchia CC, Adkins T, Ou A, Guerrero P, Kapoor S, Gallardo JM, Tai KW, Paa JA, Boyd K, Gonzalez N, Masini R, Vallet N, DiLoreto DA, Chung MM, Stoutenburg AM, Fedick N, Schaefer T, Goole MM, Addams LM, Fischer WS, Tutko J, Marcus DM, Singh H, Zapata GR, McAteer MC, Benson J, Hill CM, Overton KY, Hendrickson J, Freeman B, Ivey K, Oldag VL, Ridley ME, Schafer ML, Munoz D, Brogdon AA, Lummis JT, Peterson DC, Cisco JK, Abrams GW, Puklin JE, Schulz LL, Milanovic C, Krzeminski VR, Silvis B, Morehead KM, Sadikovic Z, Lambert HM, Miller PS, Busch SK, Lazarte VN, Fredrickson D, Morales JA, Schmidt AW, Gitter KA, Willson RL, Batlle IR, Marvel CB, Schomaker K, Trese MT, Williams GA, Capone A, Ruby AJ, Zajechowski M, Mitchell BL, Huckabone C, Treuter TF, Bridges CD, Szydlowski LD, Streasick P, Guenther ML, Drouilhet JH, Pelke S, Nobler D, Bell T, Larrison WI, Karnolt A, Abraham P, Livermont K, Green BL, Potter E, Parks D, Tu ES, Pince KJ, Fong DS, Chase P, Moore BA, Krzystolik MG, Henriques S, German E, Bache JE, Beck RW, Glassman AR, Barros J, Dale BB, Constantine SR, Dupre SS, Edwards AR, Hutton M, Johnson PA, Kollman C, Lester LA, Loggins BL, McClellan SL, Murtaugh P, Moke PS, Qin H, Pritchard R, Ramirez H, Scott E, Stockdale CR, Davis MD, Danis RP, Hubbard L, Reimers J, Vargo P, Moeller E, Myers D, Daywalt M, Bressler NM, Aiello LP, Everett DF, Miskala PH, Ip MS, Aiello LP, Beck RW, Bressler NM, Clark WL, Daniels SA, Davis MD, Everett DF, Ferris F, Glassman AR, Greven CM, Starr J, Browning D, Danis RP, Elman MJ, Grinnell CJ, Hampton GR, Heath WR, Krzystolik MG, Lauer A, McLeod K, Miskala P, Ortiz DJ, Callanan D, Stone TW, Wong KL, Bressler NM, Aiello LP, Beck RW, Bhavsar A, Danis RP, Davis MD, Everett DF, Ferris FL, Fish J, Friedman S, Glassman AR, Lauer A, Brown DM, Browning DJ, Elman MJ, McLeod K, Miskala PH, Grinnell CJ, Connett J, Barnbaum D, Flynn HW Jr, Frank RN, Genuth S, Jampol L, Wisniewski S, Resnick J.

Author information

  • 1Jaeb Center for Health Research, Tampa, FL 33647, USA. drcrnetB3@jaeb.org

Abstract

OBJECTIVE:

To evaluate the efficacy and safety of 1-mg and 4-mg doses of preservative-free intravitreal triamcinolone in comparison with focal/grid photocoagulation for the treatment of diabetic macular edema (DME).

DESIGN:

Multicenter, randomized clinical trial.

PARTICIPANTS:

Eight hundred forty study eyes of 693 subjects with DME involving the fovea and with visual acuity of 20/40 to 20/320.

METHODS:

Eyes were randomized to focal/grid photocoagulation (n = 330), 1 mg intravitreal triamcinolone (n = 256), or 4 mg intravitreal triamcinolone (n = 254). Retreatment was given for persistent or new edema at 4-month intervals. The primary outcome was evaluated at 2 years.

MAIN OUTCOME MEASURES:

Visual acuity measured with the electronic Early Treatment Diabetic Retinopathy Study method (primary), optical coherence tomography-measured retinal thickness (secondary), and safety.

RESULTS:

At 4 months, mean visual acuity was better in the 4-mg triamcinolone group than in either the laser group (P<0.001) or the 1-mg triamcinolone group (P = 0.001). By 1 year, there were no significant differences among groups in mean visual acuity. At the 16-month visit and extending through the primary outcome visit at 2 years, mean visual acuity was better in the laser group than in the other 2 groups (at 2 years, P = 0.02 comparing the laser and 1-mg groups, P = 0.002 comparing the laser and 4-mg groups, and P = 0.49 comparing the 1-mg and 4-mg groups). Treatment group differences in the visual acuity outcome could not be attributed solely to cataract formation. Optical coherence tomography results generally paralleled the visual acuity results. Intraocular pressure increased from baseline by 10 mmHg or more at any visit in 4%, 16%, and 33% of eyes in the 3 treatment groups, respectively, and cataract surgery was performed in 13%, 23%, and 51% of eyes in the 3 treatment groups, respectively.

CONCLUSIONS:

Over a 2-year period, focal/grid photocoagulation is more effective and has fewer side effects than 1-mg or 4-mg doses of preservative-free intravitreal triamcinolone for most patients with DME who have characteristics similar to the cohort in this clinical trial. The results of this study also support that focal/grid photocoagulation currently should be the benchmark against which other treatments are compared in clinical trials of DME.

Comment in

  • Diabetic macular edema. [Ophthalmology. 2009]
  • DRCR Study: outcomes in focal vs diffuse edema? [Ophthalmology. 2009]
  • Diabetic macular edema. [Ophthalmology. 2009]
  • Diabetic macular edema. [Ophthalmology. 2009]
  • Diabetic macular edema. [Ophthalmology. 2009]
  • A new look at an old treatment for diabetic macular edema. [Ophthalmology. 2008]
PMID:
18662829
[PubMed - indexed for MEDLINE]
PMCID:
PMC2748264
Free PMC Article
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