Tags

Type your tag names separated by a space and hit enter

Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema: Two-Year Results from a Comparative Effectiveness Randomized Clinical Trial.
Ophthalmology. 2016 06; 123(6):1351-9.O

Abstract

PURPOSE

To provide 2-year results comparing anti-vascular endothelial growth factor (VEGF) agents for center-involved diabetic macular edema (DME) using a standardized follow-up and retreatment regimen.

DESIGN

Randomized clinical trial.

PARTICIPANTS

Six hundred sixty participants with visual acuity (VA) impairment from DME.

METHODS

Randomization to 2.0-mg aflibercept, 1.25-mg repackaged (compounded) bevacizumab, or 0.3-mg ranibizumab intravitreous injections performed up to monthly using a protocol-specific follow-up and retreatment regimen. Focal/grid laser photocoagulation was added after 6 months if DME persisted. Visits occurred every 4 weeks during year 1 and were extended up to every 4 months thereafter when VA and macular thickness were stable.

MAIN OUTCOME MEASURES

Change in VA, adverse events, and retreatment frequency.

RESULTS

Median numbers of injections were 5, 6, and 6 in year 2 and 15, 16, and 15 over 2 years in the aflibercept, bevacizumab, and ranibizumab groups, respectively (global P = 0.08). Focal/grid laser photocoagulation was administered in 41%, 64%, and 52%, respectively (aflibercept vs. bevacizumab, P < 0.001; aflibercept vs. ranibizumab, P = 0.04; bevacizumab vs. ranibizumab, P = 0.01). At 2 years, mean VA improved by 12.8, 10.0, and 12.3 letters, respectively. Treatment group differences varied by baseline VA (P = 0.02 for interaction). With worse baseline VA (20/50 to 20/320), mean improvement was 18.1, 13.3, and 16.1 letters, respectively (aflibercept vs. bevacizumab, P = 0.02; aflibercept vs. ranibizumab, P = 0.18; ranibizumab vs. bevacizumab, P = 0.18). With better baseline VA (20/32 to 20/40), mean improvement was 7.8, 6.8, and 8.6 letters, respectively (P > 0.10, for pairwise comparisons). Anti-Platelet Trialists' Collaboration (APTC) events occurred in 5% with aflibercept, 8% with bevacizumab, and 12% with ranibizumab (global P = 0.047; aflibercept vs. bevacizumab, P = 0.34; aflibercept vs. ranibizumab, P = 0.047; ranibizumab vs. bevacizumab, P = 0.20; global P = 0.09 adjusted for potential confounders).

CONCLUSIONS

All 3 anti-VEGF groups showed VA improvement from baseline to 2 years with a decreased number of injections in year 2. Visual acuity outcomes were similar for eyes with better baseline VA. Among eyes with worse baseline VA, aflibercept had superior 2-year VA outcomes compared with bevacizumab, but superiority of aflibercept over ranibizumab, noted at 1 year, was no longer identified. Higher APTC event rates with ranibizumab over 2 years warrants continued evaluation in future trials.

Authors+Show Affiliations

Palmetto Retina Center, Columbia, South Carolina.Jaeb Center for Health Research, Tampa, Florida.Jaeb Center for Health Research, Tampa, Florida. Electronic address: drcrstat1@jaeb.org.Department of Ophthalmology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.Scheie Eye Institute, University of Pennsylvania, Philadelphia, Pennsylvania.National Eye Institutes, National Institutes of Health, Bethesda, Maryland.Retina-Vitreous Surgeons of Central New York, PC, Syracuse, New York.Retina Research Center, Austin, Texas.Jaeb Center for Health Research, Tampa, Florida.Jaeb Center for Health Research, Tampa, Florida.No affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

26935357

Citation

Wells, John A., et al. "Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema: Two-Year Results From a Comparative Effectiveness Randomized Clinical Trial." Ophthalmology, vol. 123, no. 6, 2016, pp. 1351-9.
Wells JA, Glassman AR, Ayala AR, et al. Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema: Two-Year Results from a Comparative Effectiveness Randomized Clinical Trial. Ophthalmology. 2016;123(6):1351-9.
Wells, J. A., Glassman, A. R., Ayala, A. R., Jampol, L. M., Bressler, N. M., Bressler, S. B., Brucker, A. J., Ferris, F. L., Hampton, G. R., Jhaveri, C., Melia, M., & Beck, R. W. (2016). Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema: Two-Year Results from a Comparative Effectiveness Randomized Clinical Trial. Ophthalmology, 123(6), 1351-9. https://doi.org/10.1016/j.ophtha.2016.02.022
Wells JA, et al. Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema: Two-Year Results From a Comparative Effectiveness Randomized Clinical Trial. Ophthalmology. 2016;123(6):1351-9. PubMed PMID: 26935357.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema: Two-Year Results from a Comparative Effectiveness Randomized Clinical Trial. AU - Wells,John A, AU - Glassman,Adam R, AU - Ayala,Allison R, AU - Jampol,Lee M, AU - Bressler,Neil M, AU - Bressler,Susan B, AU - Brucker,Alexander J, AU - Ferris,Frederick L, AU - Hampton,G Robert, AU - Jhaveri,Chirag, AU - Melia,Michele, AU - Beck,Roy W, AU - ,, Y1 - 2016/02/27/ PY - 2016/01/08/received PY - 2016/02/05/revised PY - 2016/02/09/accepted PY - 2016/3/4/entrez PY - 2016/3/5/pubmed PY - 2017/6/27/medline SP - 1351 EP - 9 JF - Ophthalmology JO - Ophthalmology VL - 123 IS - 6 N2 - PURPOSE: To provide 2-year results comparing anti-vascular endothelial growth factor (VEGF) agents for center-involved diabetic macular edema (DME) using a standardized follow-up and retreatment regimen. DESIGN: Randomized clinical trial. PARTICIPANTS: Six hundred sixty participants with visual acuity (VA) impairment from DME. METHODS: Randomization to 2.0-mg aflibercept, 1.25-mg repackaged (compounded) bevacizumab, or 0.3-mg ranibizumab intravitreous injections performed up to monthly using a protocol-specific follow-up and retreatment regimen. Focal/grid laser photocoagulation was added after 6 months if DME persisted. Visits occurred every 4 weeks during year 1 and were extended up to every 4 months thereafter when VA and macular thickness were stable. MAIN OUTCOME MEASURES: Change in VA, adverse events, and retreatment frequency. RESULTS: Median numbers of injections were 5, 6, and 6 in year 2 and 15, 16, and 15 over 2 years in the aflibercept, bevacizumab, and ranibizumab groups, respectively (global P = 0.08). Focal/grid laser photocoagulation was administered in 41%, 64%, and 52%, respectively (aflibercept vs. bevacizumab, P < 0.001; aflibercept vs. ranibizumab, P = 0.04; bevacizumab vs. ranibizumab, P = 0.01). At 2 years, mean VA improved by 12.8, 10.0, and 12.3 letters, respectively. Treatment group differences varied by baseline VA (P = 0.02 for interaction). With worse baseline VA (20/50 to 20/320), mean improvement was 18.1, 13.3, and 16.1 letters, respectively (aflibercept vs. bevacizumab, P = 0.02; aflibercept vs. ranibizumab, P = 0.18; ranibizumab vs. bevacizumab, P = 0.18). With better baseline VA (20/32 to 20/40), mean improvement was 7.8, 6.8, and 8.6 letters, respectively (P > 0.10, for pairwise comparisons). Anti-Platelet Trialists' Collaboration (APTC) events occurred in 5% with aflibercept, 8% with bevacizumab, and 12% with ranibizumab (global P = 0.047; aflibercept vs. bevacizumab, P = 0.34; aflibercept vs. ranibizumab, P = 0.047; ranibizumab vs. bevacizumab, P = 0.20; global P = 0.09 adjusted for potential confounders). CONCLUSIONS: All 3 anti-VEGF groups showed VA improvement from baseline to 2 years with a decreased number of injections in year 2. Visual acuity outcomes were similar for eyes with better baseline VA. Among eyes with worse baseline VA, aflibercept had superior 2-year VA outcomes compared with bevacizumab, but superiority of aflibercept over ranibizumab, noted at 1 year, was no longer identified. Higher APTC event rates with ranibizumab over 2 years warrants continued evaluation in future trials. SN - 1549-4713 UR - https://www.unboundmedicine.com/medline/citation/26935357/Aflibercept_Bevacizumab_or_Ranibizumab_for_Diabetic_Macular_Edema:_Two_Year_Results_from_a_Comparative_Effectiveness_Randomized_Clinical_Trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0161-6420(16)00206-2 DB - PRIME DP - Unbound Medicine ER -