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JAMA Ophthalmol. 2016 Feb;134(2):127-34. doi: 10.1001/jamaophthalmol.2015.4599.

Association of Baseline Visual Acuity and Retinal Thickness With 1-Year Efficacy of Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema.

Collaborators (440)

Tennant MT, Baker CF, Greve MD, Hinz BJ, Somani R, Cruess AF, Dickinson JD, Gupta RR, Hoskin-Mott A, Kozousek V, Samad A, Koushan K, Berger AR, Chow DR, Mandell MA, Yoganathan P, Navajas EV, Albiani D, Chui L, Kirker AW, Ma PE, Maberley DA, Merkur A, Brent MH, Mandelcorn ED, Schadlu R, Schadlu AP, Seetharam SS, Christoforidis JB, Salehi-Had H, Daniels SA, Leong CJ, Ranchod TM, Verne AZ, Daniels SA, Leong CJ, Ranchod TM, Verne AZ, Pieramici DJ, Castellarin AA, Dhoot D, Nasir MA, Steinle N, Rofagha S, Brinton DA, Jung JJ, Lee SS, Lit ES, Fan JT, Huang LL, Rauser ME, Khurana RN, Bansal AS, Boldrey EE, Borrillo JL, Palmer JD, Pesavento RD, Carlson JP, Chin EK, Murthy RC, Novack RL, Esmaili DD, Liao DS, Tabandeh H, Chang MA, Equi RA, Pearlman JA, Reed JB, Telander DG, Tsai T, Wendel RT, Diddie KR, Dessouki A, Chen H, Chow C, Monahan PM, Gasperini JL, McBeath J, Roh ML, Chan CK, Lalezary M, Lin SG, Moshiri A, Morse LS, Park SS, Yiu GC, de Koo LC, Haffner GM, Chaudhry NA, Townsend JH, Friedman SM, Moinfar N, Burgess SK, Lara TM, Lehr JT, Kaushal S, Ghuman AT, Raskauskas PA, Sharma AG, Walker JP, Wing G, Samy CN, Kraut RJ, Suner IJ, Hammer ME, Peden MC, del Cid MR, Dhalla MS, Halperin LS, Thompson WS, Shienbaum G, Gonzalez MA, Lara WC, Levy JH, Chen M, Levy MH, Gupta SK, Bawcombe DP, Chalam KV, Grover S, Gupta SK, Hendrick AM, Cribbs BE, Hubbard GB, Jain N, Robinson J, Yan J, Stoltz RA, Jacobson MS, Koh SS, Lampert SI, Miller JJ, Rivellese MJ, Sharma JB, Stallman JB, Vanderveldt SL, Meleth AD, Kooragayala LM, Marcus DM, Singh H, Kaufman PL, Lewis GM, McCluskey JD, Drouilhet JH, Scott MH, Nielsen JS, Alliman KJ, Saggau DD, Labriola LT, Tsipursky LT, Bhatia SP, Chiranand P, Maker MP, Lyon AT, Fawzi AA, Gill MK, Mirza RG, MacCumber MW, Ravage ZB, Lim JI, Chan RV, Chau FY, Leiderman YI, Ulanski LJ, Sheth VS, Bhatt HK, Jager RD, Lazarus HS, Maturi RK, Fox GM, Batlle IR, Christensen RD, Cooper BA, Dyer DS, Singh RS, Suiter BG, Singh A, Baker CW, Tilford RH, Stone TW, Isernhagen RD, Kitchens JW, Purkiss TJ, Shirkey BL, Wood WJ, Aiello LP, Andreoli CM, Arrigg PG, Murtha TJ, Schlossman DK, Shah ST, Sharuk GS, Silva PS, Sun JK, Westerfeld C, Shah CP, Cleary TS, Morley MG, Wiegand TW, Velez G, Rand LI, McCabe FJ, Baker BJ, Defrin MH, Elman MJ, Leder HA, Solomon SD, Colina JF, Brady CJ, Bressler NM, Bressler S, Finkelstein D, Meyerle CB, Scholl HP, Scott AW, Wenick AS, Edwards PA, Desai U, Gao H, Hessburg T, Kumar N, Gardner TW, Comer GM, Devisetty LV, Johnson MW, Shah AR, Zacks DN, Aaberg TM, Pezda NF, Shevchenko L, Westhouse SJ, Ramasamy SR, Glazer LC, DeHorn KU, Garber FW, Zheutlin JD, Barkmeier AJ, Bakri SJ, Iezzi R, Smith WM, Bhavsar AR, Emerson GG, Emerson MV, Jones JM, Koozekanani D, Montezuma SR, Rosenthal WN, Blinder KJ, Krummenacher TK, Smith BT, Sabates FN, Kunjukunju N, Blinder KJ, Krummenacher TK, Smith BT, Browning D, Antoszyk AN, Punjabi OS, Garg S, Houghton OM, Ulrich JN, Stone CM, Do DV, Chace R, Shah SP, Fine HF, Roth DB, Foxman BT, Foxman SG, Margolis TI, Chiu MT, Pitcher JD 3rd, Ramaiya KJ, Reddy AK, Wyant FW, Das A, Rosberger DF, Brooks NO, Mian UK, Gentile RC, Barzideh N, Gupta M, Rose SJ, Connolly BP, Hall EF, Hampton GR, Brown JS, Rosenberg KI, Seth RK, Lema GM, Gentile RC, Barzideh N, Gupta M, DiLoreto DA, Chung MM, Kleinman DM, Ramchandran RS, Kiss S, D'Amico DJ, Orlin A, Ahmad BU, Hyon KY, Singerman LJ, Coney JM, Miller DG, Novak MA, Rao LJ, Schartman JP, Ahmad BU, Hyon KY, Kingsley RM, Fransen SR, Leonard RE, Shah VA, Shah SN, Phelps BS, Ridges RM, Lauer AK, Bailey ST, Campbell JP, Flaxel CJ, Hwang TS, Edwards AO, Hunter AA 3rd, Peters MA, Lee MS, Ma C, Patel AK, Tlucek PS, Greene JM, Linares HM, Pavlica MR, Olsen KR, Bergren RL, Conrad PW, Doft BH, Rath PP, Vyas AP, Olsen KR, Bergren RL, Conrad PW, Doft BH, Rath PP, Vyas AP, Brucker AJ, Kim BJ, VanderBeek BL, Gross JG, Fishburne BC, Neamtu VA, Wells JA 3rd, Clark WL, Payne JF, Breazeale RI, DeCroos F, Shah RJ, Googe JM, Anderson NG, Perkins SL, Shuler RK, Cummings HL, Gunn JM, Wong RW, Day S, Martinez JA, Nixon PA, Carvounis PE, Weng CY, Singer MA, Bell DJ, Khawly JA, Chang E, Rahman HT, Tzu JH, Wykoff CC, Benz MS, Brown DM, Chen E, Fish RH, Kim RY, Major JC, Schefler AC, Shah AR, Wong TP, Berger BB, Chexal S, Jhaveri CD, Mein CE, Chica MA, Holy SE, Rush RB, Fish GE, Wang RC, Shami M, Gonzalez VH, Adyanthaya R, Patel NR, Santiago JG, Kwun RC, Brinton EP, Brinton GS, Howard JG, Knudsen VL, Swartz M, Winward KE, O'Keefe JS, Astruc JA, Schwent BJ, Tabassian AR, Brar VS, Mansour SE, Chisholm LD, Lauer AK, Bailey ST, Campbell JP, Flaxel CJ, Hwang TS, Peters MA, Lee MS, Ma C, Patel AK, Tlucek PS, Wirthlin RS, Cheek AG, Guglielmo ES, Kinyoun JL, Chao JR, Rezaei KA, Kim JE, Connor TB, Han DP, Stepien KE, Weinberg DV, Wirostko WJ, Gottlieb J, Altaweel MM, Blodi BA, Danis RP, Ip MS, Mititelu M.

Author information

1
Palmetto Retina Center, West Columbia, South Carolina.
2
Jaeb Center for Health Research, Tampa, Florida.
3
Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
4
Beetham Eye Institute, Joslin Diabetes Center, Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts.
5
Charlotte Eye, Ear, Nose and Throat Associates, PA, Charlotte, North Carolina.
6
Paducah Retinal Center, Paducah, Kentucky.
7
Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland8Editor, JAMA Ophthalmology.
8
Elman Retina Group, Baltimore, Maryland.
9
National Eye Institute, National Institutes of Health, Bethesda, Maryland.
10
Florida Retina Consultants, Winter Haven.
11
California Retina Consultants, Santa Barbara.

Erratum in

Abstract

IMPORTANCE:

Comparisons of the relative effect of 3 anti-vascular endothelial growth factor agents to treat diabetic macular edema warrant further assessment.

OBJECTIVE:

To provide additional outcomes from a randomized trial evaluating 3 anti-vascular endothelial growth factor agents for diabetic macular edema within subgroups based on baseline visual acuity (VA) and central subfield thickness (CST) as evaluated on optical coherence tomography.

DESIGN, SETTING, AND PARTICIPANTS:

Post hoc exploratory analyses were conducted of randomized trial data on 660 adults with diabetic macular edema and decreased VA (Snellen equivalent, approximately 20/32 to 20/320). The original study was conducted between August 22, 2012, and August 28, 2013. Analysis was conducted from January 7 to June 2, 2015.

INTERVENTIONS:

Repeated 0.05-mL intravitreous injections of 2.0 mg of aflibercept (224 eyes), 1.25 mg of bevacizumab (218 eyes), or 0.3 mg of ranibizumab (218 eyes) as needed per protocol.

MAIN OUTCOMES AND MEASURES:

One-year VA and CST outcomes within prespecified subgroups based on both baseline VA and CST thresholds, defined as worse (20/50 or worse) or better (20/32 to 20/40) VA and thicker (≥400 µm) or thinner (250 to 399 µm) CST.

RESULTS:

In the subgroup with worse baseline VA (n = 305), irrespective of baseline CST, aflibercept showed greater improvement than bevacizumab or ranibizumab for several VA outcomes. In the subgroup with better VA and thinner CST at baseline (61-73 eyes across 3 treatment groups), VA outcomes showed little difference between groups; mean change was +7.2, +8.4, and +7.6 letters in the aflibercept, bevacizumab, and ranibizumab groups, respectively. However, in the subgroup with better VA and thicker CST at baseline (31-43 eyes), there was a suggestion of worse VA outcomes in the bevacizumab group; mean change from baseline to 1 year was +9.5, +5.4, and +9.5 letters in the aflibercept, bevacizumab, and ranibizumab groups, respectively, and VA letter score was greater than 84 (approximately 20/20) in 21 of 33 (64%), 7 of 31 (23%), and 21 of 43 (49%) eyes, respectively. The adjusted differences and 95% CIs were 39% (17% to 60%) for aflibercept vs bevacizumab, 25% (5% to 46%) for ranibizumab vs bevacizumab, and 13% (-8% to 35%) for aflibercept vs ranibizumab.

CONCLUSIONS AND RELEVANCE:

These post hoc secondary findings suggest that for eyes with better initial VA and thicker CST, some VA outcomes may be worse in the bevacizumab group than in the aflibercept and ranibizumab groups. Given the exploratory nature of these analyses and the small sample size within subgroups, caution is suggested when using the data to guide treatment considerations for patients.

TRIAL REGISTRATION:

clinicaltrials.gov Identifier: NCT01627249.

PMID:
26605836
PMCID:
PMC5567793
DOI:
10.1001/jamaophthalmol.2015.4599
[Indexed for MEDLINE]
Free PMC Article

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