دورية أكاديمية
Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema.
| العنوان: | Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. |
|---|---|
| المؤلفون: | Wells JA, Glassman AR, Ayala AR, Jampol LM, Aiello LP, Antoszyk AN, Arnold-Bush B, Baker CW, Bressler NM, Browning DJ, Elman MJ, Ferris FL, Friedman SM, Melia M, Pieramici DJ, Sun JK, Beck RW |
| مؤلفون مشاركون: | Diabetic Retinopathy Clinical Research Network |
| المصدر: | The New England journal of medicine [N Engl J Med] 2015 Mar 26; Vol. 372 (13), pp. 1193-203. Date of Electronic Publication: 2015 Feb 18. |
| نوع المنشور: | Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural |
| اللغة: | English |
| بيانات الدورية: | Publisher: Massachusetts Medical Society Country of Publication: United States NLM ID: 0255562 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1533-4406 (Electronic) Linking ISSN: 00284793 NLM ISO Abbreviation: N Engl J Med Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Boston, Massachusetts Medical Society. |
| مواضيع طبية MeSH: | Antibodies, Monoclonal, Humanized/*administration & dosage , Diabetic Retinopathy/*drug therapy , Macular Edema/*drug therapy , Receptors, Vascular Endothelial Growth Factor/*administration & dosage , Recombinant Fusion Proteins/*administration & dosage , Vascular Endothelial Growth Factor A/*antagonists & inhibitors , Visual Acuity/*drug effects, Adult ; Aged ; Angiogenesis Inhibitors/administration & dosage ; Antibodies, Monoclonal, Humanized/adverse effects ; Bevacizumab ; Double-Blind Method ; Female ; Humans ; Intravitreal Injections ; Male ; Middle Aged ; Ranibizumab ; Receptors, Vascular Endothelial Growth Factor/adverse effects ; Recombinant Fusion Proteins/adverse effects ; Retina/drug effects ; Retina/pathology ; Therapeutic Equivalency |
| مستخلص: | Background: The relative efficacy and safety of intravitreous aflibercept, bevacizumab, and ranibizumab in the treatment of diabetic macular edema are unknown. Methods: At 89 clinical sites, we randomly assigned 660 adults (mean age, 61±10 years) with diabetic macular edema involving the macular center to receive intravitreous aflibercept at a dose of 2.0 mg (224 participants), bevacizumab at a dose of 1.25 mg (218 participants), or ranibizumab at a dose of 0.3 mg (218 participants). The study drugs were administered as often as every 4 weeks, according to a protocol-specified algorithm. The primary outcome was the mean change in visual acuity at 1 year. Results: From baseline to 1 year, the mean visual-acuity letter score (range, 0 to 100, with higher scores indicating better visual acuity; a score of 85 is approximately 20/20) improved by 13.3 with aflibercept, by 9.7 with bevacizumab, and by 11.2 with ranibizumab. Although the improvement was greater with aflibercept than with the other two drugs (P<0.001 for aflibercept vs. bevacizumab and P=0.03 for aflibercept vs. ranibizumab), it was not clinically meaningful, because the difference was driven by the eyes with worse visual acuity at baseline (P<0.001 for interaction). When the initial visual-acuity letter score was 78 to 69 (equivalent to approximately 20/32 to 20/40) (51% of participants), the mean improvement was 8.0 with aflibercept, 7.5 with bevacizumab, and 8.3 with ranibizumab (P>0.50 for each pairwise comparison). When the initial letter score was less than 69 (approximately 20/50 or worse), the mean improvement was 18.9 with aflibercept, 11.8 with bevacizumab, and 14.2 with ranibizumab (P<0.001 for aflibercept vs. bevacizumab, P=0.003 for aflibercept vs. ranibizumab, and P=0.21 for ranibizumab vs. bevacizumab). There were no significant differences among the study groups in the rates of serious adverse events (P=0.40), hospitalization (P=0.51), death (P=0.72), or major cardiovascular events (P=0.56). Conclusions: Intravitreous aflibercept, bevacizumab, or ranibizumab improved vision in eyes with center-involved diabetic macular edema, but the relative effect depended on baseline visual acuity. When the initial visual-acuity loss was mild, there were no apparent differences, on average, among study groups. At worse levels of initial visual acuity, aflibercept was more effective at improving vision. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01627249.). |
| التعليقات: | Comment in: N Engl J Med. 2015 Mar 26;372(13):1260-1. doi: 10.1056/NEJMe1500351. (PMID: 25692914) Comment in: N Engl J Med. 2015 Jul 30;373(5):481-2. doi: 10.1056/NEJMc1505684. (PMID: 26222565) Comment in: N Engl J Med. 2015 Jul 30;373(5):479. doi: 10.1056/NEJMc1505684. (PMID: 26222566) Comment in: N Engl J Med. 2015 Jul 30;373(5):480. doi: 10.1056/NEJMc1505684. (PMID: 26222567) Comment in: N Engl J Med. 2015 Jul 30;373(5):480-1. doi: 10.1056/NEJMc1505684. (PMID: 26222568) Comment in: Eye (Lond). 2023 Nov;37(16):3367-3375. doi: 10.1038/s41433-023-02507-x. (PMID: 36977936) |
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| معلومات مُعتمدة: | UG1 EY014231 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; EY23207 United States EY NEI NIH HHS; U10 EY023207 United States EY NEI NIH HHS; EY18817 United States EY NEI NIH HHS |
| فهرسة مساهمة: | Investigator: D Browning; AN Antoszyk; AK Price; SL Fredenberg; JT Herby; CJ Fleming; AA McClain; SA Ennis; KR Gallagher; AS Karow; AC Grupp; D Puskas; L Watson; SJ Bojaj; UM Balasubramaniam; D McClain; DR Styles; JA Kuopus; K Kimrey; LM Clark; LA Jackson; MD McOwen; M Dunlap; SJ Held; DJ Pieramici; MA Nasir; AA Castellarin; D Dhoot; S Fishbein; J Giust; L Wan; MS Hanna; MD Rabena; J Smith; LJ Bone; K Avery; M Giust; A Walker; AH Shook; S Esau; NL Ruvalcaba; JA Wells; W Clark; DL Johnson; JF Payne; TR Swinford; MM Taylor; CL Garrison; PD Miller; AR Houlahan; CA O'Neill; A Floyd; CC Parker; C Sease; T Graham; R Spencer; TN Ogbuewu; A Studebaker; T Huggins; R Spivey; B Jones; A Williams; R Petty; EL Poston; G Ward; CW Baker; RH Tilford; TM Caldwell; LF Lambert; MJ Palmer; TR Martin; TR Williams; S Kettler; AB Camp; PS Silva; PG Arrigg; GS Sharuk; ST Shah; JK Sun; C Westerfeld; CM Andreoli; LP Aiello; D Schlossman; T Murtha; H Kwak; FM Flores; ME Stockman; T Kieser; MN Krigman; L Bestourous; ES Weimann; JD Cavallerano; KM Hock; MA Robertson; RK Kirby; SL Papaconstantinou; KM Madigan; RW Cavicchi; KA Palitsch; T Yilmaz; BB Berger; CD Jhaveri; T Moore; GJ Manhart; RA Walsh; I Gunderson; D Riepen; CA Bravenec; RM Reid; Y Ren; B Ostrander; CC Stovall; MJ Elman; RA Liss; HA Leder; J Starr; JL Belz; CK Putzulo; DR Sandler; JL Simmons; PV Singletary; A Davis; PM Simpson; T Coffey; DJ Ketner; T Cain; AM Metzger; P Sotirakos; MJ Elman; RA Liss; HA Leder; J Starr; JL Belz; CK Putzulo; DR Sandler; JL Simmons; PV Singletary; A Davis; PM Simpson; T Coffey; DJ Ketner; T Cain; AM Metzger; P Sotirakos; DM Marcus; H Singh; CN Roberts; GL Floyd; SO Ortiz; V Mims; L Foster; C Coursey; JC Gardner; K Ivey; JS O'Keefe; JA Astruc; BJ Schwent; AR Tabassian; SA Rosen; DC Vaughan; J Michaels; NJ Arndt; JJ Maziarz; SM Friedman; N Moinfar; KA Williamson; DF Fagan; KL Dawson; PN Walters; A McKinney; S Carlton; RC Kwun; VL Knudsen; KE Winward; M Swartz; JG Howard; M Riley; G Taylor; M Holt; JG Winward; A Walsh; T Taylor; D Walsh; G Hampton; JS Brown; RK Seth; LJ Sienkiewycz; DA Appleton; CJ Grinnell; CA Cowley; LM Kwasniewski; ML Manley; NE Robarge; SR DeSantis; PB Hay; TM DeForge; CC Wykoff; TP Wong; E Chen; DM Brown; RY Kim; JC Major; AC Schefler; RH Fish; MS Benz; M Lipman; A Hutson; N Landaverde; AE Chancey; C Cone; T Royse; VA Sneed; BA Almanza; B Dives; BA Richter; EN Kegley; AK Lauer; CJ Flaxel; ST Bailey; M Schain; AD Lundquist; SA Hanel; SD Ira; SK Nolte; PN Steinkamp; DM Ryan; SR Pickell; JT Hui; M Brix; J Barth; CS Howell; GM Fox; BA Cooper; IR Batlle; LR Manning; KA Batlle; H Wyrick; K Pippin; S Perkins; FT Yeager; RB Rush; GR Gardner; C Rush; JR Hawkins; B Dumas; B Ysasaga; CP Shah; MG Morley; TW Wiegand; TS Cleary; TM Topping; L Colegrove; K Bechtel; B Johnson; L Lebedew; N Lorius; SG Chong; JL Stone; MC Jones; D Donovan; S Malone; M Graham; A Santos; SA Bennett; KJ Blinder; BT Smith; GS Nobel; RF Weeks; EA Hoehn; MA Stuart; KE Pepple; LK Boyd; BG Pulliam; SA Schremp; SL Guevara; J Wehmeier; TL Wright; DL Gabel; DG Miller; JP Schartman; LJ Singerman; JM Coney; MA Novak; LJ Rao; SC Rath; E McNamara; L Stone; VA Smith; C Rykena; KA DuBois; MA Ilc; V Tanner; K Drury; TM Nitzsche; GA Greanoff; JC DuBois; SK Burgess; TM Lara; NH Pereda; CV Fernandez; D Davis; E Quinchia; K Workman; JS Nielsen; JH Sohn; KJ Alliman; DD Saggau; M Parker; B George; CL Eastvold; K Sells; TJ Woehl; MA Johnson; H Keenan; JL Coleman; J Spillman; S Freeman; LS Schmidt; LM Boender; JL Partin; BR Bennett; J Rostvold; CM Stone; LR Raymer; AK Menzel; LD Rickman; B Campbell; LP Sherlin; LH Hawkins; ML Buckner; ON Matsipura; PA Price; A Ghuman; PA Raskauskas; AG Sharma; G Wing; JP Walker; E Knips; C Kiesel; CY Peters; C Ryan; L Greenhoe; NN Torres; RJ Youngblood; D Turnbo; AH Leslie; EC Schoeman; RK Kiesel; RM Kingsley; VA Shah; RE Leonard; HR Miller; S Icks; VA Bergman; VK Drummond; BL Ross; RD Ellis; TR Whittington; SR Almeida; AM Butt; R Burris; MA Peters; MS Lee; PS Tlucek; C Ma; S Hobbs; 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CG Kincaid; E Castillo; CS Wienecke; SL Schlichting; B Nakoski; KR Diddie; DM Cadwell; L Van Arsdale; TF Boisvert; J Galonsky; S O'Hayer; ML Johnson; FJ McCabe; BJ Baker; MH Defrin; MV Lampson; H Pratte; SA Baron; AS Borelli; FH Davidorf; MB Wells; S Chang; JB Christoforidis; AD Letson; JA Salerno; JG Perry; SE Shelley; PJ Fish; MH Scott; JA Dixon; SR Walsh; PM Ozpirincci; BL Tebon; MJ Moyle; MR Pavlica; NS Matta; CM Brubaker; AB Backer; N Bhagat; C Fay; T Mikheyeva; M Lazar; JD Ellenberger; B Malpica; AJ Brucker; BJ Kim; BL VanderBeek; S Drossner; JC DuPont; R Salvo; SB Engelhard; JM Berger; S Morales; B Serpentine; PL Kaufman; JD McCluskey; KT Wynne; J Jordan; B Watson; RS Wirthlin; ES Guglielmo; EA Dittman; DC Waidelich; CJ Garza; AM Stone; AN Oakes; IJ Suner; ME Hammer; MC Peden; JR Traynom; R DenBoer; H Vargo; S Ramsey; AK Malzahn; D Jeffres; NA Chaudhry; SP Shah; GM Haffner; E German; S Moreau; LA Fox; JM Matteson; JL Pelletier; A Fontecchio; E Morse; G McNamara; MG Laglivia; ML Scherf; A LaPre; JA Cocilo; A Das; L Friesen; M Franco; J Lucero; M Frazier; R Laviolette; UK Mian; RL Riemer; E Koestenblatt; LV Wolf; C Kim; I Katkovskaya; E Otoo; KA Ellerbe; K Boyd; C Costa; PA Edwards; H Gao; T Hessburg; U Desai; J Murphy; MK Monk; J Hall; M Mazurek; KM Ventimiglia; BA Rusinek; BA Stern; K Brouhard; KM Weier; M Allis; J Shaken; NM Massu; TA Troszak; D Burley; AR Bhavsar; GG Emerson; JM Jones; TA Anderson; A Gilchrist; MD Peloquin; G Gaid; Y Vang; S Ryan; D Vang; AC Evans; T Scherer; HS Lazarus; DP Bunch; LC Davis; K Booth; M Trimble; MA Bledsaw; J Moore; DF Rosberger; S Groeschel; MA Madry; N DiGirolamo; D Pressley; R Santora; YM Gomez; KR Olsen; RL Bergren; P Conrad; PP Rath; AP Vyas; JC Liu; LA Merlotti; JL Chamberlin; HM Mechling; ME Kelly; K Marfisi; KA Yeckel; VL Bennett; CM Schultz; GA Rigoni; J Walter; MA Forish; A Fec; CL Foreman; D Steinberg; KD McBroom; MC Chen; MH Levy; W Torres; P Jelemensky; TL Raphael; J Rich; M Sneath; JL Kinyoun; GA Vemulakonda; SA Rath; PK Ernst; JA Pettingill; RC Jones; BC Clifton; JD Leslie; SD Solomon; NM Bressler; LK Levin; D Donohue; M Frey; L Larez; K Murray; RL Denbow; J Graul; D Emmert; C Herring; N Rhoton; J Belz; AT Lyon; RG Mirza; AM Krug; C Ramirez; L Kaminski; AL Castro-Malek; AN Mills; Z Rozenbajgier; ML Skelly; E Simjanoski; AR Degillio; JI Lim; FY Chau; M Niec; T Johnson; Y Ovando; M Janowicz; C Carroll; JG Gross; BC Fishburne; AM Flowers; R Stroman; C Ochieng; AS McDowell; AM Paul; RL Price; JH Drouilhet; EN Lacaden; DJ Nobler; HL Cummings; DJ Long; B McCord; J Robinson; J Swift; JP Maynard; PJ Pahk; H Palmer-Dwore; DH Dave; M Pacheco; BA Galati; E Simpson; AJ Barkmeier; DL Vogen; KA Berg; SL Howard; JM Burrington; JA Morgan; JT Overend; S Goddard; DM Lewison; JL Tesmer; CM Greven; J Fish; C Everhart; MD Clark; DT Miller; AM Hendrick; GB Hubbard; J Yan; BE Cribbs; LT Curtis; JL Brower; JL Dobbs; DJ Jordan; BU Ahmad; SS Huang; HM Sedlacek; CL Hornsby; LP Ferguson; K Carlton; KA Sholtis; P Allchin; C Clow; MA Harrod; G Pankhurst; I Baum-Rawraway; SA Hrvatin; RC Gentile; A Yang; W Carrasquillo-Boyd; R Masini; CN Samy; RJ Kraut; K Shirley; L Corso; K Ely; E Scala; S Gross; V Alava; E Margalit; DG Neely; M Blaiotta; L Hagensen; AE Harris; RL Lennon; DR Cota; L Wilson; JA Wells; LP Aiello; RW Beck; NM Bressler; SB Bressler; KV Chalam; RP Danis; BJ Arnold-Bush; F Ferris; SM Friedman; AR Glassman; MH Scott; JK Sun; RW Wong; AR Glassman; RW Beck; T Almukhtar; BJ Arnold-Bush; BB Dale; A Baptista; C Connor; J Conner; SR Constantine; K Dowling; SS Dupre; AR Ayala; ML Huggins; S Inusah; PA Johnson; BL Loggins; SL McClellan; M Melia; E Battle; CR Stockdale; D Stanley; G Jaffe; B Balsley; M Barbas; R Burns; D Busian; R Ebersohl; C Heydary; S McEwan; J Myers; A Robertson; K Shields; G Thompson; K Winter; E Young; RP Danis; MD Davis; Y Huang; B Blodi; A Domalpally; J Reimers; P Vargo; H Wabers; D Myers; D Lawrence; J Allan; LM Jampol; NM Bressler; A Antoszyk; CW Baker; JK Sun; JA Wells; S Friedman; SB Bressler; IU Scott; E Schron; DF Everett; PH Miskala; J Connett; G Abrams; DR Barnbaum; H Flynn; RS Weinstock; CP Wilkinson; S Wisniewski; S Genuth; R Frank; LP Aiello; AN Antoszyk; CW Baker; RW Beck; NM Bressler; SB Bressler; RP Danis; MD Davis; MJ Elman; FL Ferris; AR Glassman; JG Gross; GJ Jaffe; LM Jampol; RK Maturi; E Schron; JK Sun; JA Wells; A Bhavsar; AJ Brucker; KV Chalam; DF Everett; J Fish; S Friedman; J Googe; DM Holcomb; A Lauer; DM Marcus; A McClain; BJ Perez; IU Scott; J Starr |
| سلسلة جزيئية: | ClinicalTrials.gov NCT01627249 |
| المشرفين على المادة: | 0 (Angiogenesis Inhibitors) 0 (Antibodies, Monoclonal, Humanized) 0 (Recombinant Fusion Proteins) 0 (Vascular Endothelial Growth Factor A) 15C2VL427D (aflibercept) 2S9ZZM9Q9V (Bevacizumab) EC 2.7.10.1 (Receptors, Vascular Endothelial Growth Factor) ZL1R02VT79 (Ranibizumab) |
| تواريخ الأحداث: | Date Created: 20150219 Date Completed: 20150402 Latest Revision: 20240610 |
| رمز التحديث: | 20240610 |
| مُعرف محوري في PubMed: | PMC4422053 |
| DOI: | 10.1056/NEJMoa1414264 |
| PMID: | 25692915 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1533-4406 |
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| DOI: | 10.1056/NEJMoa1414264 |