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N Engl J Med. 2011 May 19;364(20):1897-908. doi: 10.1056/NEJMoa1102673. Epub 2011 Apr 28.

Ranibizumab and bevacizumab for neovascular age-related macular degeneration.

Collaborators (861)

Williams DF, Beardsley S, Bennett S, Cantrill H, Chan-Tram C, Cheshier H, Davies J, Dev S, Enloe J, Follano G, Gilbert P, Johnson J, Jones T, Mayleben L, Mittra R, Moos M, Neist R, Oestreich N, Quiram P, Ramsay R, Ryan E, Schindeldecker S, Steele T, Tonsfeldt J, Valardi S, Fish GE, Aguado HA, Arceneaux S, Arnwine J, Bell K, Bell T, Boleman B, Bradley P, Callanan D, Coors L, Creighton J, Cummings K, Dock C, Duignan K, Fuller D, Gray K, Hendrix B, Hesse N, Jaramillo D, Jost B, Lash S, Lonsdale L, Mackens M, Mutz K, Potts M, Sanchez B, Snyder W, Solley W, Tarter C, Wang R, Williams P, Perkins SL, Anderson N, Arnold A, Blais P, Googe J, Higdon TT, Hunt C, Johnson M, Miller J, Moore M, Morris CK, Morris C, Oelrich S, Oliver K, Seitz V, Whetstone J, Doft BH, Bedel J, Bergren R, Borthwick A, Conrad P, Fulwylie C, Ingram W, Latham S, Lester G, Liu J, Lobes L, Lucko NM, Merlotti L, Olsen K, Puskas D, Rath P, Schueckler L, Schultz C, Shultz H, Steinberg D, Vyas A, Whale K, Yeckel K, Orth DH, Arredondo LS, Brown S, Ciscato BJ, Civantos JM, Figliulo C, Hasan S, Kosinski B, Muir D, Nelson K, Packo K, Pollack JS, Rezaei K, Shelton G, Townsend-Patrick S, Walsh M, McDonald HR, Ansari N, Bye A, Fu AD, Grout S, Indermill C, Johnson RN, Jumper JM, Linares S, Lujan BJ, Munden A, Rodriguez R, Rose JM, Teske B, Urias Y, Young S, Dreyer RF, Daniel H, Connaughton M, Handelman I, Hobbs S, Hoerner C, Hudson D, Kopfer M, Lee M, Lemley C, Logan J, Ma C, Mallet C, Milliron A, Peters M, Wohlsein H, Pearlman JA, Andrews M, Bartlett M, Carlson N, Cox E, Equi R, Gonzalez M, Griffin S, Hogue F, Kennedy L, Kryuchkov L, Lopez C, Lopez D, Luevano B, McKenna E, Patel A, Reed B, Secor N, Sison IR, Tsai T, Varghis N, Waller B, Wendel R, Yebra R, Roth DB, Deinzer J, Fine H, Green F, Green S, Keyser B, Leff S, Leviton A, Martir A, Mosenthine K, Muscle S, Okoren L, Parker S, Prenner J, Price N, Rogers D, Rosas L, Schlosser A, Studenko L, Tantum T, Wheatley H, Trese MT, Aaberg T, Bezaire D, Bridges C, Bryant D, Capone A, Coleman M, Consolo C, Cook C, DuLong C, Garretson B, Grooten T, Hammersley J, Hassan T, Jessick H, Jones N, Kinsman C, Krumlauf J, Lewis S, Locke H, Margherio A, Markus D, Marsh T, Neal S, Noffke A, Oh K, Pence C, Preston L, Raphaelian P, Regan VR, Roberts P, Ruby A, Sarrafizadeh R, Scherf M, Scott S, Sneed S, Staples L, Terry B, Trese MT, Videtich J, Williams G, Zajechowski M, Joseph DP, Blinder K, Boyd L, Buckley S, Crow M, Dinatale A, Engelbrecht N, Forke B, Gabel D, Grand G, Grillion-Cerone J, Holekamp N, Kelly C, Nobel G, Pepple K, Raeber M, Rao PK, Ressel T, Schremp S, Sgorlon M, Shears S, Thomas M, Timma C, Vaughn A, Walters C, Weeks R, Wehmeier J, Wright T, Berinstein DM, Ayyad A, Barazi MK, Bickhart E, Byank L, Cronise A, Denny V, Dunn C, Flory M, Frantz R, Garfinkel RA, Gilbert W, Lai MM, Melamud A, Newgen J, Newton S, Oliver D, Osman M, Sanders R, von Fricken M, Dugel P, Arenas S, Balea G, Bartoli D, Bucci J, Cornelius JA, Dickens S, Doherty D, Dunlap H, Goldenberg D, Jamal K, Jimenez N, Kavanagh N, Kunimoto D, Martin J, Miner J, Mobley S, Park D, Quinlan E, Sipperley J, Slagle C, Smith D, Yager R, Flaxel CJ, Bailey S, Francis P, Howell C, Hwang T, Ira S, Klein M, Lauer A, Liesegang T, Lundquist A, Nolte S, Nolte SK, Pickell S, Pope S, Rossi J, Schain M, Steinkamp P, Toomey MD, Vahrenwald D, West K, Hubbard B, Andelman S, Bergstrom C, Brower J, Cribbs B, Curtis L, Dobbs J, DuBois L, Gaultney J, Gibbs D, Jordan D, Leef D, Martin DF, Myles R, Olsen T, Schwent B, Srivastava S, Waldron R, Antoszyk AN, Balasubramaniam U, Brooks D, Brown J, Browning D, Clark L, Ennis S, Helms JV, Herby J, Karow A, Leotaud P, Massimino C, McClain D, McOwen M, Mindel J, Pereira C, Pierce R, Powers M, Price A, Rohrer J, Sanders J, Avery RL, Avery K, Basefsky J, Beckner L, Castellarin A, Couvillion S, Giust J, Giust M, Nasir M, Pieramici D, Rabena M, Risard S, See R, Smith J, Bakri SJ, Abu-Yaghi N, Barkmeier A, Berg K, Burrington J, Edwards A, Goddard S, Howard S, Iezzi R, Lewison D, Link T, McCannel CA, Overend J, Pach J, Ruszczyk M, Shultz R, Stephan C, Vogen D, Bradford RH Jr, Bergman V, Burris R, Butt A, Daniels B, Dwiggins C, Fransen S, Guerrero T, Haivala D, Harris A, Icks S, Kingsley R, Richmond R, Ross B, White K, Youngberg M, Topping TM, Bennett S, Chong S, Cleary T, Corey E, Donovan D, Frederick A, Freese L, Graham M, Gud N, Howard T, Jones M, Morley M, Moses K, Stone J, Ty R, Wiegand T, Williams L, Winder B, Awh CC, Arrindell E, Beck D, Busbee B, Dilback A, Downs S, Guidry A, Gutow G, Hardin J, Hines S, Hutchins E, LaCivita K, Lester A, Malott L, McCain M, Miracle J, Moffat K, Palazzotta L, Robinson K, Sonkin P, Travis A, Wallace R, Winters KJ, Wray J, Harris AE, Bunnell M, Crooks K, Fitzgerald R, Javid C, Kew C, Kill E, Kline P, Kreienkamp J, Moore R, Saavedra E, Taylor L, Walsh M, Wilson L, Ciulla TA, Coyle E, Harrington T, Harris C, Maturi R, Morrow S, Savage J, Sink B, Steele T, Thukral N, Wilburn J, Walker JP, Banks J, Ciampaglia D, Dyshanowitz D, Frederick J, Ghuman AT, Grodin R, Kiesel C, Knips E, Peters C, Raskauskas P, Schoeman E, Sharma A, Wing G, Chandra SR, Altaweel M, Blodi B, Burke K, Dietzman KA, Gottlieb J, Knutson G, Krolnik D, Nork TM, Olson S, Peterson J, Reed S, Soderling B, Somers G, Stevens T, Wealti A, Bearelly S, Branchaud B, Bryant JW, Crowell S, Fekrat S, Gammage M, Harrison C, Jones S, McClain N, McCuen B, Mruthyunjaya P, Queen J, Sarin N, Skalak C, Skelly M, Suner I, Tomany R, Welch L, Park SS, Cassidy A, Chandra K, Good I, Imson K, Kaur S, Metzler H, Morse L, Redenbo E, Salvador M, Telander D, Thomas M, Wallace C, Barr CC, Battcher A, Bottorff M, Chasteen M, Clark K, Denning D, Schultz A, Tempel E, Whittington GK, Stone TW, Blevins T, Buck M, Cruz L, Heath W, Holcomb D, Isernhagen R, Kidd T, Kitchens J, Sears C, Slade E, Van Arsdall J, VanHoose B, Wolfe J, Wood W, Zilis J, Crooks C, Disney L, Liu M, Petty S, Sall S, Folk JC, Aly T, Brotherton A, Critser D, Hinz CJ, Karakas S, Lester C, Montague C, Russell S, Stockman H, Taylor B, Verdick R, Thompson JT, Connell B, Constantine M, Davis JL Jr, Holsapple G, Hunter L, Lenane CN, Mitchell R, Russel L, Sjaarda R, Brown DM, Benz M, Burns L, Carranza JG, Fish R, Goates D, Hay S, Jeffers T, Kegley E, Kubecka D, McGilvra S, Richter B, Sneed V, Stoever C, Tellez I, Wong T, Kim I, Andreoli C, Barresi L, Brett S, Callahan C, Capaccioli K, Carli W, Coppola M, Emmanuel N, Evans C, Fagan A, Grillo M, Head J, Kieser T, Lord U, Miretsky E, Palitsch K, Petrin T, Reader L, Reznichenko S, Robertson M, Vavvas D, Wells J, Cahill C, Clark WL, Henry K, Johnson D, Miller P, Oliver L, Spivey R, Taylor M, Lambert M, Chase K, Fredrickson D, Khawly J, Lazarte V, Lowd D, Miller P, Willis A, Ferrone PJ, Almonte M, Arnott R, Aviles I, Carbon S, Chitjian M, Damore K, Elliott C, Fastenberg D, Golub B, Graham K, Lavorna A, Murphy L, Palomo A, Puglisi C, Rhee D, Romero J, Rosenblatt B, Salcedo G, Schlameuss M, Shakin E, Sookhai V, Kaiser R, Affel E, Brown G, Centinaro C, Fine D, Fineman M, Formoso M, Garg S, Grande L, Herbert C, Ho A, Hsu J, Jay M, Lavetsky L, Liebenbaum E, Maguire J, Monsonego J, O'Connor L, Regillo C, Rosario M, Spirn M, Vander J, Walsh J, Davidorf FH, Barnett A, Chang S, Christoforidis J, Elliott J, Justice H, Letson A, McKinney K, Perry J, Salerno JA, Savage S, Shelley S, Singerman LJ, Coney J, DuBois J, DuBois K, Greanoff G, Himmelman D, Ilc M, Mcnamara E, Novak M, Pendergast S, Rath S, Smith-Brewer S, Tanner V, Weiss DE, Zegarra H, Halperin L, Aramayo P, Dhalla M, Fernandez B, Fernandez C, Lopez J, Lopez M, Mariano J, Murphy K, Sherley C, Veksler R, Rahhal F, Babikian R, Boyer D, Hami S, Kessinger J, Kurokouchi J, Mukarram S, Pachman S, Protacio E, Sierra J, Tabandeh H, Zamboni A, Elman M, Butcher T, Cain T, Coffey T, Firestone D, Gore N, Singletary P, Sotirakos P, Starr J, Meredith TA, Barnhart CJ, Cantrell D, Esquejo-Leon R, Houghton O, Kaur H, Ndure F, Glatzer R, Joffe L, Schindler R, Martin DF, Fine SL, Katz M, Maguire MG, Brightwell-Arnold M, Glaser R, Hall J, Harkins S, Huang J, Khvatov A, McWilliams K, Nolte SK, Peskin E, Pistilli M, Ryan S, Schnader A, Ying GS, Jaffe G, Afrani-Sakyi J, Balsley B, Bennett LS, Brooks A, Brower-Lingsch A, Bruce L, Burns R, Busian D, Choong J, Cloaninger L, DeCroos FC, DuBois E, El-Dairi M, Gach S, Hall K, Hawks T, Huang C, Heydary C, Ho A, Kini S, McCall M, Muhammad D, Nicholson J, Queen J, Rieves P, Shields K, Skalak C, Specker A, Stinnett S, Subramaniam S, Tenbrink P, Toth C, Towe A, Welch K, Williams N, Winter K, Young E, Grunwald JE, Alexander J, Daniel E, Flannagan E, Martin ER, Parker C, Sepielli K, Shannon T, Whearry C, Redford M, Martin DF, Avery RL, Bakri SJ, Daniel E, Fine SL, Grunwald JE, Jaffe G, Kopfer MR, Maguire MG, Meredith TA, Peskin E, Redford M, Williams DF, Martin DF, Bennett LS, Daniel E, Ferris FL 3rd, Fine SL, Grunwald JE, Jaffe G, Maguire MG, Peskin E, Redford M, Toth C, Peskin E, Brightwell-Arnold M, DuPont J, Maguire MG, McWilliams K, Nolte SK, Friedman LM, Bressler SB, DeMets DL, Friedlander M, Johnson MW, Lindblad A, Losordo DW, Miller FG.

Abstract

BACKGROUND:

Clinical trials have established the efficacy of ranibizumab for the treatment of neovascular age-related macular degeneration (AMD). In addition, bevacizumab is used off-label to treat AMD, despite the absence of similar supporting data.

METHODS:

In a multicenter, single-blind, noninferiority trial, we randomly assigned 1208 patients with neovascular AMD to receive intravitreal injections of ranibizumab or bevacizumab on either a monthly schedule or as needed with monthly evaluation. The primary outcome was the mean change in visual acuity at 1 year, with a noninferiority limit of 5 letters on the eye chart.

RESULTS:

Bevacizumab administered monthly was equivalent to ranibizumab administered monthly, with 8.0 and 8.5 letters gained, respectively. Bevacizumab administered as needed was equivalent to ranibizumab as needed, with 5.9 and 6.8 letters gained, respectively. Ranibizumab as needed was equivalent to monthly ranibizumab, although the comparison between bevacizumab as needed and monthly bevacizumab was inconclusive. The mean decrease in central retinal thickness was greater in the ranibizumab-monthly group (196 μm) than in the other groups (152 to 168 μm, P=0.03 by analysis of variance). Rates of death, myocardial infarction, and stroke were similar for patients receiving either bevacizumab or ranibizumab (P>0.20). The proportion of patients with serious systemic adverse events (primarily hospitalizations) was higher with bevacizumab than with ranibizumab (24.1% vs. 19.0%; risk ratio, 1.29; 95% confidence interval, 1.01 to 1.66), with excess events broadly distributed in disease categories not identified in previous studies as areas of concern.

CONCLUSIONS:

At 1 year, bevacizumab and ranibizumab had equivalent effects on visual acuity when administered according to the same schedule. Ranibizumab given as needed with monthly evaluation had effects on vision that were equivalent to those of ranibizumab administered monthly. Differences in rates of serious adverse events require further study. (Funded by the National Eye Institute; ClinicalTrials.gov number, NCT00593450.).

Comment in

PMID:
21526923
[PubMed - indexed for MEDLINE]
PMCID:
PMC3157322
Free PMC Article

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