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Ophthalmology. 2012 Jul;119(7):1388-98. doi: 10.1016/j.ophtha.2012.03.053. Epub 2012 May 1.

Ranibizumab and bevacizumab for treatment of neovascular age-related macular degeneration: two-year results.

Collaborators (893)

Williams DF, Beardsley S, Bennett S, Cantrill H, Chan-Tram C, Cheshier H, Damato K, 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, Snater J, Steele T, Selders D, Tonsfeldt J, Valardi S, Fish GE, Aguado HA, Arceneaux S, Arnwine J, Bell K, Bell T, Bradley P, Callanan D, Coors L, Creighton J, Crew T, 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, Fec A, Fulwylie C, Ingram W, Latham S, Lester G, Liu J, Lobes L, Lucko NM, Mechling H, Merlotti L, McBroom K, Olsen K, Puskas D, Rath P, Schmucker M, 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 H, Ansari N, Bye A, Fu AD, Grout S, Indermill C, Johnson RN, Jumper J, Linares S, Lujan BJ, Munden A, Persons M, 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, Bell 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 P, 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, Brady T, 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, Yafchak M, 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, Held 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, Wan L, 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, Redden L, Richmond R, Ross B, White K, Youngberg M, Topping TM, Bennett S, Chong S, Ciotti M, 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, Amonette M, 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 RT, Winters KJ, Wray J, Harris AE, Bunnell M, Crooks K, Fitzgerald R, Javid C, Kew C, Kill E, Kline P, Kreienkamp J, Martinez M, Moore RA, Saavedra E, Taylor L, Walsh M, Wilson L, Ciulla TA, Coyle E, Harrington T, Harris C, Hood C, Kerr I, Maturi R, Moore D, Morrow S, Savage J, Sink B, Steele T, Thukral N, Wilburn J, Walker JP, Banks J, Ciampaglia D, Dyshanowitz D, Frederick J, Ghuman A, Grodin R, Kiesel C, Knips E, McCue J, Ortiz M, Peters C, Raskauskas P, Schoeman E, Sharma A, Wing G, Youngblood R, Chandra SR, Altaweel M, Blodi B, Burke K, Dietzman KA, Gottlieb J, Knutson G, Krolnik D, Nork T, 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, Schoen D, Schultz A, Tempel E, Wheeler L, 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, Kirschner V, Lester C, Montague C, Russell S, Stockman H, Taylor B, Verdick R, Walshire J, Thompson JT, Connell B, Constantine M, Davis JL Jr, Holsapple G, Hunter L, Lenane C, 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, Lee E, Lord U, Miretsky E, Palitsch K, Petrin T, Reader L, Reznichenko S, Robertson M, Smith J, Vavvas D, Wells J, Cahill C, Clark W, Henry K, Johnson D, Miller P, Clark L, Spivey R, Swinford T, 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, Pierce 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, Belz J, 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 E, 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.

Author information

  • 1Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA.

Abstract

OBJECTIVE:

To describe effects of ranibizumab and bevacizumab when administered monthly or as needed for 2 years and to describe the impact of switching to as-needed treatment after 1 year of monthly treatment.

DESIGN:

Multicenter, randomized clinical trial.

PARTICIPANTS:

Patients (n = 1107) who were followed up during year 2 among 1185 patients with neovascular age-related macular degeneration who were enrolled in the clinical trial.

INTERVENTIONS:

At enrollment, patients were assigned to 4 treatment groups defined by drug (ranibizumab or bevacizumab) and dosing regimen (monthly or as needed). At 1 year, patients initially assigned to monthly treatment were reassigned randomly to monthly or as-needed treatment, without changing the drug assignment.

MAIN OUTCOME MEASURES:

Mean change in visual acuity.

RESULTS:

Among patients following the same regimen for 2 years, mean gain in visual acuity was similar for both drugs (bevacizumab-ranibizumab difference, -1.4 letters; 95% confidence interval [CI], -3.7 to 0.8; P = 0.21). Mean gain was greater for monthly than for as-needed treatment (difference, -2.4 letters; 95% CI, -4.8 to -0.1; P = 0.046). The proportion without fluid ranged from 13.9% in the bevacizumab-as-needed group to 45.5% in the ranibizumab monthly group (drug, P = 0.0003; regimen, P < 0.0001). Switching from monthly to as-needed treatment resulted in greater mean decrease in vision during year 2 (-2.2 letters; P = 0.03) and a lower proportion without fluid (-19%; P < 0.0001). Rates of death and arteriothrombotic events were similar for both drugs (P > 0.60). The proportion of patients with 1 or more systemic serious adverse events was higher with bevacizumab than ranibizumab (39.9% vs. 31.7%; adjusted risk ratio, 1.30; 95% CI, 1.07-1.57; P = 0.009). Most of the excess events have not been associated previously with systemic therapy targeting vascular endothelial growth factor (VEGF).

CONCLUSIONS:

Ranibizumab and bevacizumab had similar effects on visual acuity over a 2-year period. Treatment as needed resulted in less gain in visual acuity, whether instituted at enrollment or after 1 year of monthly treatment. There were no differences between drugs in rates of death or arteriothrombotic events. The interpretation of the persistence of higher rates of serious adverse events with bevacizumab is uncertain because of the lack of specificity to conditions associated with inhibition of VEGF.

Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Comment in

PMID:
22555112
[PubMed - indexed for MEDLINE]
PMCID:
PMC3389193
Free PMC Article

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