دورية أكاديمية
أعرض في EDS

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

التفاصيل البيبلوغرافية
العنوان: Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema.
المؤلفون: Elman MJ, Aiello LP, Beck RW, Bressler NM, Bressler SB, Edwards AR, Ferris FL 3rd, Friedman SM, Glassman AR, Miller KM, Scott IU, Stockdale CR, Sun JK
مؤلفون مشاركون: Diabetic Retinopathy Clinical Research Network
المصدر: Ophthalmology [Ophthalmology] 2010 Jun; Vol. 117 (6), pp. 1064-1077.e35. Date of Electronic Publication: 2010 Apr 28.
نوع المنشور: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural
اللغة: English
بيانات الدورية: Publisher: Elsevier Country of Publication: United States NLM ID: 7802443 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1549-4713 (Electronic) Linking ISSN: 01616420 NLM ISO Abbreviation: Ophthalmology Subsets: MEDLINE
أسماء مطبوعة: Publication: 2000- : New York : Elsevier
Original Publication: Rochester, Minn., American Academy of Ophthalmology.
مواضيع طبية MeSH: Laser Coagulation*, Antibodies, Monoclonal/*therapeutic use , Diabetic Retinopathy/*therapy , Glucocorticoids/*therapeutic use , Macular Edema/*therapy , Triamcinolone Acetonide/*therapeutic use, Aged ; Algorithms ; Antibodies, Monoclonal/adverse effects ; Antibodies, Monoclonal, Humanized ; Combined Modality Therapy ; Diabetes Mellitus, Type 1/complications ; Diabetes Mellitus, Type 2/complications ; Diabetic Retinopathy/drug therapy ; Diabetic Retinopathy/physiopathology ; Diabetic Retinopathy/surgery ; Double-Blind Method ; Female ; Follow-Up Studies ; Glucocorticoids/adverse effects ; Humans ; Injections ; Macular Edema/drug therapy ; Macular Edema/physiopathology ; Macular Edema/surgery ; Male ; Middle Aged ; Ranibizumab ; Retreatment ; Treatment Outcome ; Triamcinolone Acetonide/adverse effects ; Visual Acuity/physiology ; Vitreous Body
مستخلص: 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.
(Copyright 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)
التعليقات: Comment in: Ophthalmology. 2010 Jun;117(6):1059-60. (PMID: 20522333)
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معلومات مُعتمدة: EY14229 United States EY NEI NIH HHS; UG1 EY014231 United States EY NEI NIH HHS; U10 EY014229-07 United States EY NEI NIH HHS; U10 EY018817 United States EY NEI NIH HHS; EY14231 United States EY NEI NIH HHS; U10 EY014231 United States EY NEI NIH HHS; U10 EY023207 United States EY NEI NIH HHS; U10 EY014229 United States EY NEI NIH HHS; EY018817 United States EY NEI NIH HHS; U10 EY018817-01 United States EY NEI NIH HHS; U10 EY014231-07 United States EY NEI NIH HHS
فهرسة مساهمة: Investigator: MJ Elman; MD Sloan; TM Butcher; J Starr; N Gore; T Coffey; PV Singletary; DY Salfer-Firestone; G Andreani; DJ Ketner; P Sotirakos; T Cain; KV Chalam; S Grover; SK Gupta; TM Singh; R Keshavamurthy; S Agarwal; WW Phillips; J Sifrit; MC Patel; VS Brar; JR Carpentier; RK Maturi; T Ciulla; NF Hrisomalos; LA Bleau; CK Novak; M Storie; T Steele; A Maple; JL Poston; A Harless; SM Friedman; OZ Plous; KA Blackmer; JS Key; K Sjoblom; J Maldonado; S Walters-Treon; A McKinney; K Gostischa; S Carlton; DJ Browning; JC Brown; AN Antoszyk; DR Brooks; AK Price; MK Cowen; JV Helms; SA Ennis; RE Pierce; AS Karow; W Lail; ME Powers; D McClain; RJ George; LM Clark; KA Schlicker; PA Leotaud; AR Vittitow; UM Balasubramaniam; LM Davis; MD McOwen; JA Ballard; AK Lauer; PJ Francis; ST Bailey; TS Hwang; CJ Flaxel; SI Pope; MD Toomey; SK Nolte; SD Ira; T Liesegang; AD Lundquist; M Schain; DR Vahrenwald; CS Howell; JC Rossi; PR Wallace; KL West; PN Steinkamp; PB Rice; SR Pickell; TW Stone; JW Kitchens; WJ Wood; RD Isernhagen; DM Holcomb; JL Cruz; CA Sears; B VanHoose; M Buck; JL Wolfe; J Van Arsdall; WR Heath; EA Slade; ST Blevins; T Kidd; TA McMillan; SL Perkins; NG Anderson; JM Googe; CT Higdon; S Evans; CD Morris; C Hunt; M Moore; MM Johnson; K Oliver; VL Seitz; A Arnold; M Jacobus; JK Whetstone; PA Blais; SM Oelrich; WL Clark; JA Wells; MM Taylor; CP Cahill; MD Gridine; PD McDougal; KL Henry; R Spivey; ML Henderson; P Tankersley; LL Oliver; AB Hickman; JB Michelson; LA Teasley; P Manjarrez; A Garcia; C Lee; G Suderno; J Keppler; P Yoo; P Paquette; SA Daniels; TD Ting; SK Ray; CJ Leong; MC Aguilos; KJ Dowell; GM Marudo; CM Moreci; RJ Tejada; TH Nguyen; SM Teshima-McCormick; A Schrock; WM Combs; N Hom; MD Hughes; F Hanamoto; MS Dhalla; WS Thompson; S Anagnoste; JA Brady-Lopez; CV Fernandez; E Quinchia; J Mariano; CM Sherley; P Aramayo; ML Ritchie; KL McHugh; BM Fernandez; HM Lambert; AW Willis; JA Khawly; R Diaz-Rohena; PS Miller; SK Busch; D Fredrickson; VN Lazarte; KL Davis; JA Morales; KJ Chase; DK Lowd; JE Muniz; AW Schmidt; AR Bhavsar; GG Emerson; MV Emerson; VT Huynh; TM Olson; DJ Boll; M Yafchak; CH Hager; SL Pearson; DL Selders; CM Smith; C Chan-Tram; WB Carli; JA Kells; L Taylor-Reetz; SD Solomon; AW Scott; NM Bressler; DV Do; S Bressler; M Frey; S West; D Donohue; V Kellner; D Cain; J Graul; J Mc-Donald; D Emmert; SM Shah; J Belt; C Herring; JT Fan; MB Suthar; ME Rauser; CL Davidson; G Santiago; KE Rollins; CJ Corliss; CG Quesada; WH Kiernan; RG Obispo; J Knabb; CW Baker; TM Caldwell; TR Martin; MJ Palmer; LF Lambert; TR Williams; AB Travis; DD Darden; BB Berger; E Chen; RW Wong; K Davis; JR Lummus; GJ Manhart; TL Clevenger-Smith; N Callen; MT Gartner; JL Sun; GL Abeyta; B Ostrander; Y Ren; JG Gross; MA Magee; AM Flowers; KL Henry; AS McDowell; CM Fore; HK Lovit; JC Rohrer; KK Bland; AM Paul; CN Mallet; R Christoff; RL Price; JL Gottlieb; BA Blodi; MS Ip; KF Burke; BH Soderling; SR Olson; AM Wealti; SF Somers; KA Dietzman; GE Knutson; DA Krolnik; JC Peterson; MA Novak; JM Coney; DG Miller; LJ Singerman; L Stone; E McNamara; TM Nitzsche; KA Dubois; V Tanner; TL Cunningham; SK Smith-Brewer; JC DuBois; GA Greanoff; JK Sun; LP Aiello; DK Schlossman; ST Shah; PG Arrigg; PS Silva; GS Sharuk; TJ Murtha; ME Stockman; JA Barenholtz; RK Kirby; RM Calderon; JD Cavallerano; JC BuAbbud; ES Weimann; L Bestourous; RW Cavicchi; A Koplle; M Shami; SR Smith; Y Saldivar; P Pusser; A Meeks; NR Garcia; L Squires; CL Tarter; TF Wentlandt; MA Peters; CA Lemley; MS Lee; IL Handelman; RF Dreyer; S Hobbs; DA Brunelle; M Kopfer; W Raunig; G Durbin; H Daniel; J Logan; CN Mallet; H Wohlsein; DJ Pieramici; MA Nasir; CA Castellarin; MD Rabena; J Smith; AL Sterling; D Hernandez; K Avery; JC Basefsky; L Tramel; K Boyer; SM Risard; M Giust; CM Greven; MM Slusher; J Fish; C Everhart; FM Ledbetter; LN Cooke; DT Miller; MD Clark; M Tyler; DM Marcus; H Singh; GR Zapata; MC McAteer; D Blair; KA Leverett; C Powell; CM Hill; KY Overton; JC Coxville; K Ivey; VL Oldag; TA Ghuman; G Wing; JP Walker; PA Raskauskas; AG Sharma; RW Grodin; C Kiesel; JL Frederick; E Knips; C Ryan; CY Peters; JM Banks; D Dyshanowitz; EC Schoeman; RG Hampton; PF Torrisi; BK Rutledge; SC Spalding; CJ Grinnell; ML Manley; LM Kwasniewski; PB Hay; LA Capone; KM Harrison; RL Novack; D Boyer; H Tabandeh; A Tam; S Mukarram; T Gasparyan; JK Gilmour; J Sanguinet; J Sierra; SE Pachman; EG Protacio; J Kessinger; A Smucker; ME Hartnett; TA Meredith; S Garg; OM Houghton; CJ Barnhart; F N'Dure; D Morck; D Cantrell; RL Esquejo; JL Kinyoun; GA Vemulakonda; SA Rath; PK Burrows; PK Ernst; JA Pettingill; BC Clifton; JD Leslie; C Stephens; TM Topping; TA Cleary; LA Freese; L Williams; VM Hurley; PP Zand; EA Corey; JL Stone; TN Howard; R Ty; SG Chong; KL Moses; M Graham; SA Bennett; MC Jones; MH Scott; PM Wiegman; MM Runde; TR Dvorak; MJ Humphrey; BL Tebon; JE Kim; DP Han; DV Weinberg; TB Connor; W Wirostko; KE Stepien; VV Williams; J Graf; KL Packard; S Rekow; D Alvarez; J Flanders; V Barwick; DB Backes; JR Beringer; KL Keller; KJ Selchert; SS Huang; SC Wilker; J Tang; A Malik; K Carlton; C Clow; S Burke; G Pankhurst; MA Harrod; GE Fish; RC Wang; J Arnwine; CL Tarter; B Sanchez; S Arceneaux; H Aguado; K Cummings; K Gray; M Mackens; BL Hendrix; D Jaramillo; AJ Brucker; SG Drossner; JC DuPont; W Xu; C Devine; W Nyberg; L Weeney; JM Berger; CE Mein; MA Chica; L Kirschbaum; E Riff; MF Tadros; CS Weineke; B Nakoski; MW MacCumber; K Lluen-Nunez; C Droira; J Pleskovich; KA Neely; IU Scott; TW Gardner; SM Chobanoff; LE Walter; M Hershey; JD Strong; TJ Bennett; HS Lazarus; DP Bunch; AD Ridge; K Booth; J Moore; M Trimble; BD Kuppermann; J Grijalva; R Magallon; B Trump; HL Cummings; DJ Long; JJ Vermillion; S Carpenter; JP Berry; RC Gentile; EA Ponce; A Ou; P Guerrero; C Guerrero; JM Gallardo; V Perez; KW Tai; JA Paa; D Jampol; R Masini; P Whitten; W Carrasquillo-Boyd; K Boyd; CK Chan; DM Salib; SG Lin; AS Nuthi; KS Walther; I Aldana; ED Dickerson; LE Myers; S Warren; SU Castillo; KM Huff; DJ Chesbrough; M Blair; JI Lim; M Niec; T Johnson; Y Ovando; M Janowicz; C Carroll; JM Braverman; AP Ciardella; H Quiroz-Mercado; LS Ryman; RC Rhodes; SI Montalvo; SR Harloff; DM Brown; SR Kaufman; MF Estafanous; KA Huff; AE Lamancusa; R Fill; M Peace; DM Williams; JS Pollack; MM MacCumber; BJ Ciscato; K Lluen-Nune; BM Kosinski; C Droira; DW Muir; J Pleskovich; R Chace; S Kallay; N Dolbec; K Stevens; R Baker-Hill; J Halbmaier; CW Smith; HA Woodcome; E Rego; CL DuCoty; S Varadian; C Salinas; E Banalewicz; AL Nagle; M Hamel
المشرفين على المادة: 0 (Antibodies, Monoclonal)
0 (Antibodies, Monoclonal, Humanized)
0 (Glucocorticoids)
F446C597KA (Triamcinolone Acetonide)
ZL1R02VT79 (Ranibizumab)
تواريخ الأحداث: Date Created: 20100430 Date Completed: 20100623 Latest Revision: 20220410
رمز التحديث: 20221213
مُعرف محوري في PubMed: PMC2937272
DOI: 10.1016/j.ophtha.2010.02.031
PMID: 20427088
قاعدة البيانات: MEDLINE
الوصف
تدمد:1549-4713
DOI:10.1016/j.ophtha.2010.02.031