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Association of Baseline Visual Acuity and Retinal Thickness With 1-Year Efficacy of Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema.
JAMA Ophthalmol. 2016 Feb; 134(2):127-34.JO

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.

Authors+Show Affiliations

Palmetto Retina Center, West Columbia, South Carolina.Jaeb Center for Health Research, Tampa, Florida.Feinberg School of Medicine, Northwestern University, Chicago, Illinois.Beetham Eye Institute, Joslin Diabetes Center, Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts.Charlotte Eye, Ear, Nose and Throat Associates, PA, Charlotte, North Carolina.Paducah Retinal Center, Paducah, Kentucky.Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland8Editor, JAMA Ophthalmology.Charlotte Eye, Ear, Nose and Throat Associates, PA, Charlotte, North Carolina.Jaeb Center for Health Research, Tampa, Florida.Elman Retina Group, Baltimore, Maryland.National Eye Institute, National Institutes of Health, Bethesda, Maryland.Florida Retina Consultants, Winter Haven.Jaeb Center for Health Research, Tampa, Florida.California Retina Consultants, Santa Barbara.Beetham Eye Institute, Joslin Diabetes Center, Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts.Jaeb Center for Health Research, Tampa, Florida.No affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

26605836

Citation

Wells, John A., et al. "Association of Baseline Visual Acuity and Retinal Thickness With 1-Year Efficacy of Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema." JAMA Ophthalmology, vol. 134, no. 2, 2016, pp. 127-34.
Wells JA, Glassman AR, Jampol LM, et al. Association of Baseline Visual Acuity and Retinal Thickness With 1-Year Efficacy of Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema. JAMA Ophthalmol. 2016;134(2):127-34.
Wells, J. A., Glassman, A. R., Jampol, L. M., Aiello, L. P., Antoszyk, A. N., Baker, C. W., Bressler, N. M., Browning, D. J., Connor, C. G., Elman, M. J., Ferris, F. L., Friedman, S. M., Melia, M., Pieramici, D. J., Sun, J. K., & Beck, R. W. (2016). Association of Baseline Visual Acuity and Retinal Thickness With 1-Year Efficacy of Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema. JAMA Ophthalmology, 134(2), 127-34. https://doi.org/10.1001/jamaophthalmol.2015.4599
Wells JA, et al. Association of Baseline Visual Acuity and Retinal Thickness With 1-Year Efficacy of Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema. JAMA Ophthalmol. 2016;134(2):127-34. PubMed PMID: 26605836.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Association of Baseline Visual Acuity and Retinal Thickness With 1-Year Efficacy of Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema. AU - Wells,John A, AU - Glassman,Adam R, AU - Jampol,Lee M, AU - Aiello,Lloyd Paul, AU - Antoszyk,Andrew N, AU - Baker,Carl W, AU - Bressler,Neil M, AU - Browning,David J, AU - Connor,Crystal G, AU - Elman,Michael J, AU - Ferris,Frederick L, AU - Friedman,Scott M, AU - Melia,Michele, AU - Pieramici,Dante J, AU - Sun,Jennifer K, AU - Beck,Roy W, AU - ,, PY - 2015/11/26/entrez PY - 2015/11/26/pubmed PY - 2016/7/1/medline SP - 127 EP - 34 JF - JAMA ophthalmology JO - JAMA Ophthalmol VL - 134 IS - 2 N2 - 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. SN - 2168-6173 UR - https://www.unboundmedicine.com/medline/citation/26605836/Association_of_Baseline_Visual_Acuity_and_Retinal_Thickness_With_1_Year_Efficacy_of_Aflibercept_Bevacizumab_and_Ranibizumab_for_Diabetic_Macular_Edema_ L2 - https://jamanetwork.com/journals/jamaophthalmology/fullarticle/10.1001/jamaophthalmol.2015.4599 DB - PRIME DP - Unbound Medicine ER -